EU Biosimilars: Video Analysis

We're pleased to announce a new content partnership with Datamonitor Healthcare. Each week they'll be sharing their latest research and insights into the Biosimilars field!

While we're still sorting the details between the new legislation and interchangeability regarding Biosimilars, the EU market is already in development stages for even later patent expiries. Recent studies show that 88 products are in various stages of development, with 75 of the products currently active. The EU market is also currently increasing in complex biologics, as well as second wave of Biosimilars.

View a presentation of key findings of 88 marketed and development stage EU biosimilars below:


To learn more about the recent EU Market and Biosimilars join us October 15-17 in Boston, MA for the 14th Annual Business of Biosimilars Conference. For more information, view our agenda. We look forward to seeing you this fall!

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Where can you hear FDA Perspectives this Fall?

At IBC’s 17th Annual Well Characterized Biologicals conference this October in Washington DC, you’ll meet and hear from multiple FDA regulators who provide you guidance to achieve success in your protein characterization and comparability efforts. We’ll help you understand all of the emerging regulatory/FDA guidances so that you can plan ahead and gain an advantage over your competitors

Hear FDA Perspective on Characterizing Biological Products

Gain an update on the US biosimilars program from Jeffrey Baker, Ph.D., Deputy Director of Biotechnology Products of CDER FDA. Obtain the latest updates on the emerging technical considerations to assure that your biosimilar products are safe and effective.

Hear regulatory considerations in the safety assessment of vaccine adjuvants and adjuvanted vaccines from Carmen Collazo-Custodio, Ph.D., Microbiologist and Primary Reviewer in the Division of Vaccines and Related Product Applications, CBER FDA. Regulatory considerations for the nonclinical and clinical safety evaluation of investigational vaccines containing novel adjuvants will be discussed.

Limit the amount of particulates in your protein therapeutics and ensure product consistency with Ewa Marszal, Ph.D., Chemist in the Hematology Division of CBER FDA's presentation on the recent advances in understanding the safety of particulate matter. Protein aggregates, testing methodologies and trends in setting standards are covered.

Be sure not to miss out on our featured FDA speaker, Alfred Del Grosso, Team Leader in Analytical Chemistry of CBER FDA's presentation on the top 10 list of analytical inadequacies in IND or BLA submissions. Hear his perspective on FDA expectation for analytical procedures and validations for drug products and drug substances.

Want to learn more? Download our agenda.

As a reader of this blog, you’ll receive 15% off the standard rate when using code XB13193BLOG to register. If you have questions about the event, contact Kate Devery (Kdevery@iirusa.com), or visit our webpage.

We look forward to seeing you October 21-23 in Washington, D.C!

Cheers,
The Well Characterized Biologicals Team

WCB Webpage
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P.S. When you register for the 17th Annual Well Characterized Biologicals conference, you’ll also have access to all sessions for the Product and Process Variants & Impurities, one of our co-located events.

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Development and Qualification of a Scalable, Disposable Bioreactor for GMP-Compliant Cell Culture

Today, we feature an article from our partners at BioProcessing International Magazine.

Development and Qualification of a Scalable, Disposable Bioreactor for GMP-Compliant Cell Culture

During the past decade, single-use bioreactors have become widely accepted for use in cell culture process development and clinical manufacturing. Their key benefits over stainless steel bioreactors are flexibility, cost, and time savings associated with the reduction of cross contamination risks (1).

Here, we describe our approach to development and qualification of the Biostat STR single-use, stirred-tank bioreactor. Unlike other stirred single-use bioreactors, it offers a similar design to that of well-established, conventional (stainless steel) stirred-tank bioreactors. Disposability of the single-use cultivation chamber gives it robustness, reliability, and reproducibility of biological results together with a supply assurance needed to meet biopharmaceutical industry requirements.

Development of a single-use bioreactor involves different phases of work (Pictured Left). The starting point should be a clear definition of the product’s intended application. Typically, related requirements are captured in a user requirement specification (URS). On the basis of that initial input, the bioreactor design and material selection are then initiated. The proof-of-concept phase establishes component- and product based tests that are predictive of the final application. Mechanical, chemical, and biological tests can be used to verify compliance with the URS during the prototype feasibility phase. Ideally, the production process should be qualified as well: Qualification efforts should cover production equipment, procedures, and parameters. Final product qualification can be based either on qualification of the individual components or the whole final product (or a combination of both) using mechanical and biological tests that emulate a specific intended application. Typically, this evaluation should be performed using bioreactor bags derived from regular manufacturing. All changes brought about (e.g., performance or robustness improvements) should be controlled by a stringent change-control process.

Download the full article here.

Follow the jump for references.

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Free Podcast on Biorepository Industry Standards

When asked, “What is one of the biggest challenges in biospecimen management today,” most executives answered, “lack of standardization.” Well, the industry is working on a solution. And we’re bringing it to you.

This September 25-27 in Boston, IIR’s 6th Annual Biorepositories and Sample Management Conference will host an exclusive Industry Standardization Workshop, where industry leaders will collaborate and begin a dialogue to create consistent global biospecimen standards.

Download this FREE podcast to hear what the leaders from Merck, NCI-BBRB, Biostorage and ISBER are saying about industry standards and listen to how they set the stage for the revolution in September.

We invite you to join the Industry Standardization Workshop! As a reader of this blog, when you register to join us and mention code XP1898BLOG, you’ll save 15% off the standard rate. Also – if you are a biorepository professional, you can buy one pass and bring a colleague for free. Rules and regulations apply.

Have any questions about the event or want to get involved? Email Jennifer Pereira.

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Biorepositories Session Spotlight: Set Best Practices in Sample Annotation to Boost the Breadth and Variety of Available Data

With potentially millions of specimens to store and keep track of, the annotation of clinical and demographic data is one of the most critically important tasks a Biorepository team and their support vendors must undertake. If you can pre-envision the needs and capabilities of your bioinformatics team, you can help improve efficiency down the road. At Biorepositories 2013, in this session, led by Genzyme, discussions some best-practices to ensure this efficiency such as engineering standardized templates to capture and represent the results of research assays and opening channels with the legal team to make sure all consent information is being archived and followed according to agreed protocols.

Biorepositories and Sample Management Conference 2013 will take place September 25-27, 2013 in Boston, MA.  For more information on this session and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us and mention code XP1898BLOG, you'll save 15% off the current rate!

Featured Session: Set Best Practices in Sample Annotation to Boost the Breadth and Variety of Available Data

Featured Speaker: Jean Cavallo, Associate Director, Molecular Pathology, Genzyme, a Sanofi Company

About the session: Annotation of clinical and demographic data of your research specimens is one of the most critically important tasks your team and support vendors must undertake – and also one of the most laborious and time-intensive. By pre-envisioning the needs and capabilities of your bioinformatics team, you can help design or select the s
oftware tools best suited for your research needs while greatly improving efficiency.

• • Engineer standardized templates to capture and represent the results of research assays for which there are no current standards
• • Overlay your data onto universally-understood vocabularies to facilitate bioinformatics research
• • Open channels with your legal team to make sure all consent information is being both archived and followed according to agreed protocols

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The 14th Annual Business of Biosimilars Agenda Is Now Available!

With Biosimilar development interest growing and the first approved monocolonal antibody in Europe this past July it will only be a matter of time before the first Biosimilar application is submitted in the US. Biosimilar market penetration is expected to grow exponentially. Are you prepared to develop a biosimilar strategy that avoids wasting time and money to be the first to market?

The 14th Annual Business of Biosimilars provides insights from market leaders including Teva, Mylan, Hospira, Sandoz, Momenta, and Boehringer Ingelheim on choosing the best pathway for the development, approval and market access of a biosimilar product. The is the only event out there that provides a unique multidisciplinary approach with a one-stop shop for all relevant topics related to Biosimilar development and market access.

Highlights include:

• THE US BIOSIMILAR LANDSCAPE
• THE GROWING GLOBAL BIOSIMILAR MARKET
• ANALYTICAL CHARACTERIZATION
• BIOSIMILAR POLICY MAKING
• MATCHING A REFERENCE PRODUCT
• CLINICAL DEVELOPMENT
• PARTNERSHIPS

To learn more, download our full agenda.

The 14th Annual Business of Biosimilars will take place October 15-17, 2012 in Boston, MA. As a reader of the Business of Biosimilars blog, you’ll receive 15% off when you use code XP1886BLOG to register. Have any questions about the event? Feel free to contact Kate Devery at kdevery@iirusa.com or visit the webpage.

Cheers,
The Business of Biosimilars Team

Business of Biosimilars Webpage
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See the new agenda for IBC’s 3rd Annual Cell Therapy Bioprocessing Conference!

The final agenda for IBC’s 3rd Annual Cell Therapy Bioprocessing Conference is now available. This year’s program provides a balance of product development strategies, process development and optimization methodologies, innovation case studies, product characterization, and bioprocessing/scale-up discussions with more contextual topics like industry overviews, CoGS cost modeling, and reimbursement.

Achieve commercial success with 20 case studies and new data presentations to help you:

• - Scale Immunotherapies Using High- Throughput Technologies Throughput Technologies
• - Streamline Manufacturing with Risk-Based, Unit Operation Approaches
• - Quantify the Investment of Your Cell Therapies Using Cost of Goods Modeling
• - Minimize Variation through Systematic Approaches to Process Design and Optimization
• - Enhance Quality and Enable Process Changes with New Potency Evaluation Strategies
• - Ensure Successful Scale Up and Validation by Establishing Process Consistency
• - Reduce Risk in Cell Therapy Applications by Developing Serum-Free Reagents

Want to find out more about these case studies, the keynotes and the rest of the agenda?

 Download the agenda.

The Cell Therapy Bioprocessing Event will take place October 21-22 in Bethesda, Maryalnd. As a reader of this blog, when you register to join us and mention code B13188JP20 and you’ll save 20% off the standard rate. Have any questions or want to get involved in this year’s event? Feel free to email Jennifer Pereira.

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Complete Response Letters are received by 42% of NDAs/BLAs, leading to approval delays of up to 26 months.

We're pleased to announce a new content partnership with Datamonitor Healthcare. Each week they’ll be sharing their latest research and insights into the Biosimilars field!

The last thing you want to receive when developing a new drug is a Complete Response Letter. What usually comes to mind when receiving a CRL? Costly delays. So what exactly can be disclosed from a CRL? And who can view it?

Want to learn more? View the complete study conducted by Datamonitor on the trends of approval successes and delays associated with CRLs.


Analysis of several case studies revealed key lessons that could be of relevance to avoiding CRLs with other NDAs/BLAs. These were:

 • Increase investment in manufacturing divisions to ensure that sites are ready for and can pass FDA inspections.
• For BLAs submitted under 351(k) or 351(a), source the reference product from the US for the purposes of comparability.
 • Fully disclose all data available that could be of relevance in the FDA’s drug benefit-risk assessment.
 • Maintain independent source documentation of data that are transmitted via electronic patient-reported outcomes.
• Retain electronic data copies for audit trails: Portable Document Format (PDF) copies alone are not sufficient.
 • Perform a thorough quality check of the entire NDA/BLA to correct all errors or omissions before submission.

To learn more about how CRLs impact the development of Biosimilars join us October 15-17 in Boston, MA for the 14th Annual Business of Biosimilars Conference. For more information, view our agenda. We look forward to seeing you this fall!

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A short history of cell culture media and the use of insulin

Today, we feature this article from our partners at BPI Magaine.

A short history of cell culture media and the use of insulin

The ancestors of cell culture media were the balanced salt solutions (BSS) devised by early workers interested in studying isolated organs ex vivo.

Such solutions provided irrigation and supply of water, bulk inorganic anions essential for normal cell metabolism, osmotic balance (isotonicity), a carbohydrate such as glucose as energy source, and a buffering system to maintain the medium within the physiological pH range (7.2 - 7.6) usually monitored by the addition of phenol red (1).

The first BSS was composed in 1885 by Sydney Ringer (1836-1910), a British clinician and pharmacologist from University College London wh
o worked on the isolated frog heart (2).

A version containing lactate is still used for intravenous perfusion. Ringer's solution was modified by Maurice V. Tyrode (1878-1930), an American physiologist born in Besançon to study isolated kidneys. Another popular balanced salt solution was devised by John H. Hanks (1906-1990), an American microbiologist, in order to attempt to cultivate the leprosy bacillusin vitro (he never succeeded) (3). Renato Dulbecco, an Italian born (1914) American virologist (who won the Nobel Prize in Physiology and Medicine in 1975 with Howard Temin and David Baltimore for their discovery of reverse transcriptase), described the much used Phosphate Buffered Saline (PBS) (4).

However it became clear that in order to get cells to actually proliferate in vitro, additional nutrients had to be added to culture media.

The first successful attempt at tissue culture is attributed to Ross Harrison (1870-1959) at Johns Hopkins University, who explanted in 1907 tadpole tissues in clotted frog lymph as nutritional and growth support, using a hanging drop on a glass slide. He was successful in observing neurite expansions (5,6).

Building on Harrison's success, the major early figure in tissue culture was Alexis Carrel (1873-1944), a French surgeon. He moved to the University of Chicago in 1903 and obtained the Nobel Prize in Physiology and Medicine in 1912 for inventing a method to suture blood vessels. In 1906 he moved to the Rockefeller Institute for Medical Reseach and started his work on tissue culture, in which he did pioneering work (124 articles, 7,8) and dominated the field, for better or for worse, until his death. He adopted Harrison's hanging drop technique but replaced the frog lymph by a plasma clot and fed the explants serum, a salt solution and chick embryo extract, which he called "plasmatic medium", which became a standard until the 1950's. His most famous experiment was the maintenance for over 34 years  of an embryonic chicken heart explant, finally discarded two years after Carrel's death. This nurtured Carrel's firm belief that primary cells in culture were immortal given the appropriate nutrition. Definitive evidence that this is wrong was provided by Leonard Hayflick (born 1928), an American gerontologist and professor of anatomy at UCSF, who demonstrated in 1965 that normal human diploid fibroblasts do not survive in vitro for more than approximately 50 divisions ("Hayflick's limit") (9).  The survival of Carrel's culture was likely due to the daily feeding of new embryonic cells from the embryonic extract.

The first continuous culture of a rodent cell line (L929) from a single cell was generated by Wilton R. Earle at the National Cancer Institute in 1943 (10). In 1951, George O. Gey (1899 -1970) at Johns Hopkins University developed the first continuous human cancer cell line from Henrietta Lacks's cervical carcinoma, the celebrated HeLa cell line whose eagerness to grow has resulted in crosscontamination of many cell cultures…

To read the rest of the white paper, visit BPI Magaine.

Follow the jump to see the References.

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See Who is Attending BioProcess International in September!

The largest and fastest growing event for the bioprocessing industry is coming to Boston on September 16-19, 2013, will you be there?

BioProcess International 2013 is your chance to mix, mingle and learn from the who’s who in the bioprocessing industry. These are just a few of the companies registered to join us in Boston:

3M Company * AbbVie BioResearch Center * Bayer Healthcare Corporation * CMC Biologics Inc * Delphi Genetics * Eli Lilly & Company * FloDesign Inc * GE Healthcare * Hamilton Company * Idexx Laboratories * Johnson & Johnson * KBI Biopharma Inc * Life Technologies * Mangan Biopharm * New England Biolabs * Olympus Biotech * Pall Life Sciences * Qosina * Refine Technology * Sandoz GmbH * TAP Biosystems * United Biochemicals * Vaxinnate Corporation * W L Gore & Associates Inc * Xcellerex Inc * ZDev Consulting

To see who you can meet this year at BPI, see the list of the growing list of pre-registered attendees.

Are you interested in finding out more about the BioProcess International Event? Download the agenda to find out more about the speakers, presentation and focuses of this year’s event.

Bioprocess International Exhibition and Conference will take place September 16-19, 2013 in Boston, MA. As a reader of this blog, when you register to join us and mention code BLOG13JP to save 20% off the standard rate!

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How are technological advances & non-traditional approaches are improving efficiency, speed, quality and cost in downstream processing?

This week, Bioprocess International Conference producer Barry Walsh shares how he believes that new technology is improving downstream processing and what he's looking forward to at this year's event.

How are technological advances and non-traditional approaches improving efficiency, speed, quality and cost in downstream processing? And what are the options and obstacles to change?

 Protein A is the foundation of the industry because it is probably applicable and it has a well-known developed pathway with predictable results. But the cost of Protein A is extremely high, sometimes exceeding $240,000 for 10 liters. However, cost of production is being dramatically reduced by the development of more efficient mechanical systems like continuous chromatography, which helps to streamline operations and eliminate waste. Advances with these systems help companies justify the continued use of Protein A and avoid the cost of equipment retrofits, cost of changing development, validation, manufacturing and other risks that would be associated with adopting a non-affinity platform. Alternatively, companies are developing alternative technology platforms because of the opportunity to substantially reduce costs in development, validation, clinical purification, manufacturing, as well as the opportunity to improve reproducibility in product quality. Some of these new technologies are able to displace the current platform. It will create a completely novel, overall paradigm in downstream processing. 

I’m really looking forward to hearing James Thomas deliver his keynote address on “Producing High-Quality, Low-Cost Biotherapeutics in the Century of Biology”. He delivered a keynote address at the first BioProcess International Conference back in 2004 and I am interested to hear his perspective on how far the industry has evolved over the past 10 years and hear what innovations lie ahead for companies in this dynamic field.

I also can’t wait to hear the debate that will take place during the point/counter-point discussion on capture options and antibody purification because it is a very polarizing topic. We will get some great answers to questions like: “Is Protein A Really doing the job?” “Is Protein A the right standard?” “Do alternatives to Protein A have serious potential and why?”

This is an excerpt from a podcast interviews series in coordination with BPI Magazine.  To hear the complete podcast along with other speaker interviews, download them by visiting this webpage.

If you'd like to join Barry in Boston this coming September 16-19 at the Bioprocess International Conference, as a reader of this blog when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate! Have any questions? Feel free to email Jennifer Pereira.

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Session Spotlight: Top 10 List of Analytical Inadequacies in IND or BLA Submissions

Procedures to support the identity, strength, quality, purity and potency of drug products and drug substances are an important component of new product applications reviewed by the FDA. Inadequacies commonly encountered in these submissions involve procedural details, system suitability tests, representative instrumental outputs, types of validation characteristics, linearity in sample matrix, verification of “compendial” procedures, robustness of critical assay parameters, accuracy calculations, precision and accuracy across intended range and factors in intermediate precision. So what exactly are the FDA expectations for analytical procedures and validations?

Session: Top 10 List of Analytical Inadequacies in IND or BLA Submissions
Speaker: Alred Del Grosso, Team Leader, Analytical Chemistry, CBER, US FDA

Join us for IBC's 17th Annual Well Characterized Biologicals as we highlight some of the errors and inadequacies FDA regulators have seen over the years in submissions. To learn more about our program, download the agenda.

As a reader of this blog, use code XB13193BLOG and save 15% off of the standard rate when you register. We look forward to seeing you October 21-23 in Washington, DC!

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Podcast: US Biosimilars Regulation – What now for substitution / interchangeability?

We're pleased to announce a new content partnership with Datamonitor Healthcare. Each week they’ll be sharing their latest research and insights into the Biosimilars field! 
It's no surprise that Biosimilar manufacturers don’t want to take a risk. There are many potential barriers with the new legislation that aims to switch prescriptions from original Biologics to comparable Biosimilars. One possible disruption? Requiring the Pharmacist to notify the Physician within 24 hours of dispensing the product. So how do you get companies on board?

Tune in to the podcast below and listen to experts, John Hodgson - Managing Editor, SCRIP Intelligence and Rory Bligh - Analyst (Companies), Datamonitor Healthcare as they cover key issues regarding the new legislation and the future of Biosimilars.

Key topics include:

• What does this legislation mean for the future of the biosimilars market?
• How will it shape upcoming legislation and regulatory changes?
• What can we learn from similar legislation that has implemented across Europe

Want to learn more about Biosimilars? Join us for the 14th Annual Business of Biosimilars event, October 15-17 in Boston, MA. Visit our website to opt in for all updates regarding Biosimilars. We look forward to seeing you this fall!

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BioProcess International Call for Posters: Have Your Research Published & Viewed by Your Industry Peers

The deadline of July 31 is approaching quickly to submit your poster abstract and take an active role at the largest BioProcessing event of the year. So much valuable research is being done by great contributors like you in the industry but are you sharing this information? I encourage you and your teams to gain the industry recognition and feedback that you need to help excel your projects.

Presenting a poster at BioProcess International can help you justify the time and cost for you to attend the conference. Not only are you attending the conference to learn new techniques and strategies, but you are also gaining well-deserved recognition for innovative research findings, successful business models, unique service propositions or creative business strategies. The event will take place September 16-19, 2013 in Boston, MA.

Submit your research on the following topic areas – space is limited!

• - Cell Culture & Upstream Processing
• - Recovery & Purification
• - Manufacturing
• - Analytical & Quality
• - Formulation/Delivery

Submit your poster entry here.

If your research topic fits one of the categories above, we encourage you to submit your poster online. To present a poster you must be a registered conference attendee.

• • The deadline to submit your poster to be included in the BPI Conference preview is July 31.
• • The deadline to submit your poster to be included in the onsite agenda and conference documentation is August 19. After this date posters will be accepted based on available space

Best Poster Awards will also be presented by BioProcess International Magazine.  Two winning posters, one academia/industry and one supplier, will be announced at the conference. They will be featured in and linked from BioProcess International Magazine's October 2013 Poster Hall eNewsletter, published in BioProcess International Magazine's November 2013 Interactive Poster Hall Supplement, and will be posted on a dedicated landing page with your pre-recorded podcast presentation on bioprocessintl.com/posters for a full year.  Check out last year's winning posters: Characterization of a Biomanufacturing Fermentation Process Using a New DOE Approach: Definitive Screening Designs and EtoxiClear™: A New Adsorbent for the Efficient Removal of Endotoxin From Biopharmaceuticals

If you'd like to join us in Boston, as a reader of this blog when you register to join us and mention priority code BPI13JP, you'll save 20% off the standard rate!  Have any questions?  Feel free to email Jennifer Pereira!

*Note: Poster abstract and full payment of conference and poster fees must be received by August 19, 2013. After that date posters are on a space available basis.

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Sources of variability in disposable bioreactors

Today, we return to Dr. Rajesh Krishnan, Associate Director of Cell Line and Upstream Process Development at Gilead Sciences Process Development Work at Gilead Sciences, podcast reported for BioProcess International. In his podcast, he looks at many aspects of single use technologies. Today, he answers the question:

What are some sources of variability in disposable bioreactors in how they perform?

Rajesh: I would say the biggest source of variability, besides potential issues with resins, would be the accuracy of process control; i.e., how well you are really controlling pH, dissolved oxygen and mixing in these different bag configurations. Process control can be impacted by many parameters, including the type of probes used (either single use or standard probes) and the design of the bag. I think that is where I’ve seen the biggest variability when I’ve done these assessments of single-use bioreactors in the past.

On the other hand, product quality variability, with material made in different single-use systems, was not really that significant in my experience.
However, another difference between single-use systems is the ease of set up and use (ex. Probe insertion into bags, placement of bags into the holders, etc). This does not really lead to process variability, but it can impact facility fit of the different bioreactors.

To hear Dr. Krishnan's entire podcast, download it here.

Dr. Krishnan will be presenting the case study Investigation and Reduction of Performance Variability in Single-use Cell Culture Bioreactors on Thursday, September 19 at Bioprocess International Conference and Exhibition. For more information on this session and the rest of the program, download the agenda. If you'd like to join us, as a reader of this blog, when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate.

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Save the date for IIR’s 14th Annual Biosimilars Event!

No other event provides the business know-how of getting biosimilars to market quickly and efficiently.Through a multidisciplinary approach of competitive intelligence, regulatory strategy, bioanalytical comparability, clinical development and more, IIR’s industry-leading 14th Business of Biosimilars provides insight from market leaders on choosing the best pathway for a Biosimilar product.

Why you should attend:

 • NEW! Pre-conference workshop—Understanding the Nuts and Bolts of Biosimilar Regulatory Requirements
• NEW! Point-counterpoint talks deliver both the Biosimilar and Brand perspectives on hot policy topics
• Navigate the EMEA approval pathway for monoclonal antibodies
• Conduct structural and PK/PD comparability assessments
• Overcome the science and complexity of indication extrapolation
• Define the role of higher order structure in fingerprinting
• Analyze current biosimilar market trends and future challenges
• And more!

Hear executive-level expert insight on critical Biosimilar success factors from:

• Mark McCamish MD, PhD, Head Global Biopharm. Development, SANDOZ INTERNATIONAL GMBH
• Michael Malecki,Director, Regulatory Policy, AMGEN
• Bruce A. Leicher,Senior Vice President and General Counsel, MOMENTA PHARMACEUTICALS
• Dr. Michel Mikhail, Chief Regulatory Officer & Executive Vice President Global Regulatory - Governmental Relations,FRESENIUS KABI
• Dr. Duncan A. Emerton, Biosimilars Practice Lead, DATAMONITOR HEALTHCARE CONSULTING
• Naomi Pearce,VP, IP Counsel and Director, Global Biologics COE, MYLAN
• Erika Lietzan, Partner, COVINGTON & BURLING LLP
• Paul Greenland,Vice President—Biologics, HOSPIRA UK LIMITED
• Magdalena Leszczyniecka PhD MBA, President and CEO, STC BIOLOGICS, INC.
• Bob Ward, VP, Head of Strategy & Alliances, New Opportunities,ASTRAZENECA
• Elizabeth Jex, Attorney Advisor, Office of Policy Planning, FEDERAL TRADE COMMISSION
• Wenyan (David) Shen,VP, Global Head of Biologics Development, TEVA

Stay Tuned! We are currently in the process of finalizing the speaking faculty as well as the event website. Be sure to check out our website for more information.
Best,
The Biosimilars Team

Biosimilars Homepage
Follow Us on Twitter: http://www.twitter.com/biosimilars

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Production challenges of complex molecules and biosimilar development

This week, we hear more from BioProcess International Conference director Michael Keenan.  He looks at how the Bioprocess International Event has strived to reach the needs help companies overcome production challenges and other emerging molecules in the industry such as biosimilars.

What changes or emerging trends have been added to this Bioprocess International program that make it imperative for them to return?

Well, there are a lot of things happening in the field right now, so we really tried to address these through the program. Companies currently are trying to figure out how to overcome production challenges of more complex molecules beyond the traditional monoclonal antibodies. So, we tried to address those in the sessions – the new kinds of complex molecules, infusions and ADCs and bi-specifics and other types of biologicals. 

There is an emerging trend on increased biosimilar development emerging in the industry, so we really tried to address this in the program. We’ve included a number of case studies that and will have speakers addressing ways how that people can prepare their offensive and defensive biosimilar strategies.

Companies are really trying to figure out how to become more flexible and efficient and really adapt to their bioprocesses depending on what the need is for the particular molecule and to give them the greatest flexibility. So, some of the things we’ve done this year in the program is add sessions related to new paradigms emerging in process development and manufacturing. One of the sessions is a new vision for product attribute controls, which is sort of a new approach being developed in the industry where companies can improve their process development and manufacturing operations by really focusing on product attributes. So, that’s one new session this year. 

We’ve also integrated the formulation and delivery track much more comprehensively within the program and that’s an emerging area, as well, that is new. 

We tried to incorporate a lot more interactive discussion sessions in the program. One that I’m pretty excited about is a session on harmonization of single-use systems, which is going to be bringing together key associations – people from the ASTM, PDA, ISPE, ASME BPE Group, BPOG and BPSA. It’s sort of a town-hall forum to discuss harmonization of single use systems with a focus on extractables and leachables. So, that’s another new addition. There are also other discussion sessions on beta testing of new technologies, looking at robust supply chain transparency, capture options and antibody purification and others.

One other final thing that I think is just a really compelling reason why people should come back this year is that we have dramatically increased the number of concrete case studies at the event this year. There are 76 this year, which is a 27% increase over 2012. There are also 96 unpublished data presentations this year, which is a 78% increase over last year. These are presentations that --- information that people can only get if they come to this year’s meeting because they may not be published elsewhere.

This is an excerpt from a podcast interviews series in coordination with BPI Magazine.  To hear the complete podcast along with other speaker interviews, download them by visiting this webpage.




If you'd like to join Michael in Boston this coming September 16-19 at the Bioprocess International Conference, as a reader of this blog when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate! Have any questions? Feel free to email Jennifer Pereira.

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Session Spotlight: Control of Process-Related Impurities for a Recombinant Seasonal Influenza Vaccine

The development of highly-purified malaria vaccines remains a challenge. Using the Pfenex Psuedomonas fluorescens expression system, a recombinant vaccine was produced to support Phase I clinical trials. So what is the best way to control process-related impurities?

 
Session: Control of Process-Related Impurities for a Recombinant Seasonal Influenza Vaccine

Speaker: Penny L. Post, PHh.D., Vice President, Regulatory, Protein Sciences Corporation

Join us for IBC's Inaugural Product and Process Variants & Impurities where we'll feature Flublok from Protein Sciences Corp., the first licensed egg-free recombinant influenza vaccine for adults, 18-49. In this presentation, Dr. Post shares the Meriden, CT-based company’s strategy for controlling process-related impurities and maintaining product quality. Want to learn more? Download our agenda.

As a reader of this blog, you'll receive 15% off of the standard rate when you mention code XB13194BLOG to register. We looking forward to seeing you October 21-23, in Washington, D.C.!

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[Podcast] Bright future for biomanufacturing

We're excited to announce a new content partnership!  We're teaming up with Datamonitor Healthcare to bring you their latest research and insights into the clinical trials field!

Growth in the biomanufacturing industry is growing at 7% according to a recent podcast with Andrew Badrot, Founder and CEO of CMS Pharma and former Vice President of Strategy at Lonza. Driving this growth in biomanufacturing are things like success in late stage clinical trials, increased production and success with the and new regulations geared at biosimilars. What speaker Badrot also points at is the over-proportional growth that will follow in the manufacturing industry. He predicts that it will grow at more than 9%. However, what traditional companies will see is more competition from emerging markets and more companies due to fewer barriers to entries as a result of single use systems.

Listen to the full podcast here.

If you're interested in finding out more about the current landscape of biomanufacturing, BioProcess International will take place this September and will continue it's look at product and process development and biomanufacturing scientists and executives to share technical, scientific and strategic solutions across all phases of bioprocess development.  For more information on this event, download the agenda.  If you'd like to join us September 16-19 in Boston, as a reader of this blog, when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate.

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How can you achieve better integration for a biopharmaceutical firm?

Last week, BioProcess International conference producer Barry Walsh shared some of the newest emerging trends and technologies in biopharmaceutical production.  This week, Michael Keenan shares how these things can be better integrated into an organization to ensure that processes are better and more fluidly completed within the organization.  How does producer Michael Keenan think BioProcess International can do this?

How is this need for better integration at all process interfaces within the organization.being addressed and facilitated at the event?

As we were doing research for the event this year, we were really hearing from a lot of people a very common theme, which is how do we break down the barriers between process development and manufacturing and even within process development? Breaking down barriers between upstream and downstream, breaking down barriers between clinical and commercial manufacturing? Even breaking down barriers between discovery up to sort of process development, really trying to make the transitions more smooth and efficient.

So, one of the ways that we tried to create a more integrated program agenda this year was by creating the concurrent conference tracks in such a way that whether you are in upstream development or downstream development, formulations, delivery, analytical quality or manufacturing, there were opportunities throughout the program for you to get specific content related to your specific interest, but yet jump to another track or another session to give you an idea of what happens before your job or after your job to help you integrate.

We have shared sessions this year. I know the upstream and downstream track have their sort of track, but we bring them together for an integrated upstream and downstream session so that both of those groups can understand and learn from each other. We have plenary sessions with fantastic keynote speakers this year, from Amgen, Genzyme, 11 biotherapeutics, Bristol Myers Squibb then Novartis on a variety of topics that will bring the entire audience together for a real keynote session and sharing of information and integration of ideas.
For the analytical quality track and the formulation development track and the manufacturing track, we also have brought those together for a shared session on one of the mornings again to facilitate this interaction and inter-discussion so that people from different disciplines can really learn from each other throughout the program.

This is an excerpt from a podcast interviews series in coordination with BPI Magazine.  To hear the complete podcast along with other speaker interviews, download them by visiting this webpage.



Next week, we'll hear from producer Michael Keenan on how he and Barry have worked to tailor the program to reach the needs of the new, emerging trends in the industry.

If you'd like to join Barry in Boston this coming September 16-19 at the Bioprocess International Conference, as a reader of this blog when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate! Have any questions? Feel free to email Jennifer Pereira.

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Celebrate America and Biorepositories! Register Thursday & Friday and save 50% off the standard rate!

Let freedom ring! Celebrate America’s freedom and YOUR freedom to register for the Biorepositories & Sample Management Conference with a 50% discount off the standard rate!*

Register to join us and mention code XP1898JULY4 to take advantage of this discount.  Visit the webpage to register.

Biorepositories will take place September 25-27, 2013 in Boston, MA. When you register, your pass includes admission to the Clinical Collaboration Congress. Your registration grants you access to both of these events — which means double the content and double the networking, too.

Have any questions? Email Jennifer Pereira.

*This promotion is only valid July 4 & 5, 2013.

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2013 BPI Conference Pre-Event Podcast Series: Upstream Processing

We’d like to share with you 2013 BPI Conference Pre-Event Podcast Series! This edition is Upstream Processing and previews what you will experience while attending the 2013 BioProcess International Conference & Exhibition this coming September.

Each of these podcast speakers will be joining us this September 16-19, 2013 in Boston for the BioProcess International Event. Featured Podcasts in this month’s upstream series are:

• The BioProcess International Conference & Exhibition: 10 Years of Industry Excellence
• By Barry Walsh and Michael Keenan, Conference Directors, IBC Life Sciences
• Apoptosis of CHO Cells Monitored by a Novel Dielectrophoretic (DEP) Cytometer
• By Michael Butler, PhD, Professor of Microbiology, University of Manitoba
• Challenges to the Entry of New Biologics into the Market
• By Joanne T. Beck, Ph.D., Vice President, Process Development, Shire Human Genetic Therapies
• Investigation and Reduction of Performance Variability in Single-Use Cell Culture Bioreactors
• By Rajesh Krishnan, PhD, Associate Director, Cell Line & Upstream Process Development, Gilead Sciences
• Fast Identification of Reliable Hosts for Targeted Cell Line Development
• By Yongping Crawford, PhD, Scientist, Early Stage Cell Culture, Genentech

To listen to each of these podcasts, visit the official webpage of the podcast series. 

Want to join these speakers and more at BioProcess International?  As a reader of this blog, we’re offering you a save 20% savings off the standard conference rates when you register to join us and mention priority code BLOG13JP when you register!*

Have any questions about the event or the program or want to get involved? Contact me jpereira@iirusa.com.

*This discount only applies to new registrations.

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