Session Spotlight: Update on United States Biosimilars Program

Because of the recently defined regulatory pathways for biosimilars, there has been a huge rise in the number of biosimilar products in development.Thorough characterization of a biosimilar candidate in comparison with the reference product is the basis for a targeted clinical development program. FDA biosimilar guidelines suggest not only to analyze isolated quality attributes but also to focus on combinations of quality parameters. So what is the current status?

Session: FDA Perspective - Update on the United States Biosimilars Program

Speaker: Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), CDER, US FDA

Want to learn more about emerging technical considerations to assure safe and efficacious biosimilar products? Join us October 21-23 in Washington, DC for the 17th Annual Well Characterized Biologicals event.

To learn more, download our brochure. Register today for the leading industry conference to provide multiple, detailed case studies of the challenges, strategies and technologies involved in characterization and comparability of new biological molecules. We look forward to seeing you this fall!

As a reader of this blog, you'll receive 20% off the standard rate when you mention the discount code XB13193BLOG to register.

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Session Spotlight: Changing the Manufacturing Process to Remove Impurities and Monitoring Product Quality Using Relevant Lot Release Assays

Process and product related impurities in therapeutic products can lead to adverse events. When CMC information related to the adverse events are available, the potential risk could be reduced by controlling the levels of the implicated impurities through changes in the manufacturing process and monitoring the quality of the product using relevant lot release assays. So where do you start?

Session: FDA Perspective - Changing the Manufacturing Process to Remove Impurities and Monitoring Product Quality Using Relevant Lot Release Assays

Speaker: Mikhail V. Ovanesov, Ph.D, Visiting Scientist, Principal Investigator, Laboratory of Hemostasis/Division of Hematology, Officer of Blood Research and Review, CBER, US FDA

Want to hear more about how changing the manufacturing process can remove impurities? Join us this October at the IBC's Inaugural Product Process Variants & Impurities Event.

For more information, download our brochure. Register today for the only industry forum covering variant and impurity control and mitigation strategies! We look forward to seeing you October 21-23 in Washington, DC.

As a reader of this blog, you'll receive 20% off the standard rate when you mention code XB13194BLOG to register.

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BioProcess International Poster Feature: EtoxiClear™: A New Adsorbent for the Efficient Removal of Endotoxin From Biopharmaceuticals

Last week, we put out a Call for Posters so that you could share your research and findings with your scientific community at the BioProcess International Conference this coming September 16-19, 2013, in Boston.  This week, we'll be looking at the two winning posters that were presented at the 2012 BioProcess International Event.  Monday, we featured Characterization of a Biomanufacturing Fermentation Process Using a New DOE Approach: Definitive Screening Designs.  Today, we feature the other winner of the BPI International poster contest.

EtoxiClear™: A New Adsorbent for the Efficient Removal of Endotoxin From Biopharmaceuticals

by Ben Galarza, Jason Shipp, Buzz Lobbezoo, Jennie Walden and Steve Burton

ProMetic BioSciences Ltd

About the poster:

Endotoxin or lipopolysaccharides (LPS) are highly toxic components of the cell wall of Gram-negative bacteria and are often present in significant amounts in bacterial cell culture expression systems such as E. coli. A number of methods have been adopted for the removal of endotoxin based on adsorption, in particular ion-exchange chromatography. Although downstream processing can significantly reduce endotoxin levels in the product, efficient and cost-effective removal of residual endotoxin from biopharmaceutical preparations remains a challenge.

This technical poster addresses the issues of removal of endotoxin from biological preparations. Specific reference will be made to a new synthetic ligand affinity adsorbent, EtoxiClear™, which exhibits high affinity for endotoxin, low protein binding and can be depyrogenated using sodium hydroxide. The bi-dentate ligand, attached to PBL’s proprietary base matrix – PuraBead®, binds in a spatially selective and optimal manner to the LPS molecule with a dynamic binding capacity for endotoxin in excess of 1,000,000 EU/mL of adsorbent (5 minute residence time). A number of biomolecules with different isoelectric points were used to demonstrate efficient recovery and clearance of residual endotoxin across the pH range. Protein recoveries in excess of 95% are achievable with endotoxin clearance to below 0.1 EU/mg protein.

Download the poster here.

If you'd like to join the Poster Hall at this year's BioProcess International, find out more at the webpage!

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BioProcess International Poster Feature: Characterization of a Biomanufacturing Fermentation Process Using a New DOE Approach: Definitive Screening Designs

Last week, we put out a Call for Posters so that you could share your research and findings with your scientific community at the BioProcess International Conference this coming September 16-19, 2013, in Boston.  This week, we'll be looking at the two winning posters that were presented at the 2012 BioProcess International Event.

Characterization of a Biomanufacturing Fermentation Process Using a New DOE Approach: Definitive Screening Designs

by Dogan Ornek, Maureen Hamilton, Michelle Chopra, Brian Kennedy, Anderson Rayford, Jesse McCool , Wenglong Lin, and Philip Ramsey, Lonza Biologics Inc.

About the poster:
Traditionally, a bioprocess is characterized using a two-step approach involving factor screening designs followed by response surface designs. This approach is very costly and time consuming since it requires a significant number of runs. Recently, Jones and Nachtscheim (2011) described a more efficient design that allows for factor screening, resolution of two-way interactions as well as estimation of quadratic effects in a single-step. The design, termed Definitive Screening has not yet been validated on a bioprocess.

Here, traditional and Definitive Screening designs were compared to characterize a pDNA fermentation process. A 15-run Definitive Screening design was evaluated against a 31-run fractional factorial design augmented with axial points to accommodate quadratic process effects. The experimental factors pH, %DO, induction temperature, induction OD600, and feed rate were included in both designs. Volumetric pDNA titer was used as the output. Both designs resulted in equivalent process characterization and modeling. Main effects, two-factor interactions, and quadratic effects in both design models were comparable. The traditional approach required 31 runs whereas the Definitive Screening approach required 15 runs. This comparison validates the use of Definitive Screening designs for fermentation process characterization; with a substantial cost and time savings over traditional DOE experimental approaches.

Download the poster here.

If you'd like to join the Poster Hall at this year's BioProcess International, find out more at the webpage!

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Download the 17th Annual Well Charaterzied Biologicals today!

The 17th annual Well Characterized Biologicals conference program is now complete and we are extremely pleased with how the final agenda turned out. This event is consistently rated as one of IBC’s most in-depth and information-packed conferences, and this year is no exception.

Program Highlights:

 • 8 Confirmed FDA/Health Canada Speakers Provide Updates on Regulatory Guidance and Expectations For Your Molecules

• 19 Case Studies and 20 Unpublished Data Presentations You Can Apply in Your CMC Programs

• Increased Networking Opportunities to Build Valuable Contacts and Expand Your Network

 • Expanded Exhibit Hall and Best Poster Award

 • New co-located event: Product and Process Variants & Impurities – Gain Access to Any Session

Want to learn more? Download our brochure.

Register today for THE leading industry conference to provide multiple, detailed case studies of the challenges, strategies and technologies involved in characterization and comparability of new biological molecules. For more information visit out website. We look forward to seeing you October 21-23 in Washington, DC.

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BioProcess International Call for Posters: Research Poster Proposals are now being accepted!

Do you have new research to share with your industry colleagues? We’re searching for the newest, innovative findings to be presented by our attendees this September 16-19, 2013 at the BioProcess International Conference & Exhibition in Boston. Share, learn from others, and be a valuable attendee at this year’s event!

What topic areas are we looking for?

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

If your research topic fits one of the categories above, we encourage you to submit your abstract! For more information on the poster program and to submit your entry,  visit the BPI Poster Page.

Two winning posters, one academia/industry and one supplier, will be announced at the conference. They will be featured in and linked from BPI's October 2013 Poster Hall eNewsletter, published in BPI'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.

You must be a registered attendee of the BioProcess International conference to present – however, as a reader of this blog, we’re offering to waive the poster fee and you’re able to save 20% off the standard rate*! Just mention priority code BLOG13JP when you register before Friday, June 28.*

*Discounts are for new registrations only. Discounted rates are based on the standard conference rates and cannot be combined with other offers. All posters must be submitted and approved by IBC in order to present.

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Save the Date: IIR’s Bioassays and Bioanalytical Method Development Event | Oct 7-9 in Berkeley, CA!

Save the date for IIR’s 9th Annual Bioassays and Bioanalytical Method Development Event the meeting place for the industry to come together to drive progress in bioanalytical R&D attracting experts from all disciplines and all levels, to share and discuss their challenges including:

•    Bi-specific and multi-specific targeting to reduce costs
•    Creating a cell-cased NAb assay in-house and its successful transfer to a CRO
•    Developing ADC assays and adhering to regulatory requirements
•    Utilizing statistical analysis to ensure accuracy and remove hurdles to FDA acceptance

Advance Strategies in Assay Development

•    NEW! Pre- Conference Summit on Reagents and Tools for Bioanalytical Method Development to ensure a reliable supply of assay materials during your research
•    NEW! Emerging Tech Showcases present up-and-coming technologies to develop and manage your bioassays
•    NEW! Interactive Roundtable discussions and session intensives offer a deep dive into those critical pain-points that may stifle productivity
•    NEW! Poster Presentations show you the newest research and technologies being developed in bioassays today
•    Plus - Back by Popular Demand!  Build your confidence in the foundational day-to-day challenges of immunology at the Immunogenicity University

Our 2013 Agenda is almost finished! Be sure to check our website for the finalized version.

We look forward to seeing you next fall!

Cheers,
The Bioassays & Bioanalytical Method Development Team

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Crucial Case Studies on In-House Biorepositories

Do you need guidance on building, staffing, supplying, monitoring and maintaining your in-house Biorepository?

By attending the 6th Annual Biorepositories and Sample Management Conference and learn the keys to optimizing your in-house operations to maximize resources and minimize costs. We have specific sessions that focus on proper design and engineering of the laboratories and storage areas associated with your biorepository:

Session: Facing the Unique Challenges of Staffing and Supplying an In-House Biopharma Tissue Repository
Speaker: Stephanie Johnson, Senior Supervisor, Human Tissue Lab, Genentech

• • Hear the challenges Genentech's Human Tissue Lab has faced and how they have been coping with them
• • Understand how to create "expertise" in biospecimen procurement, establishing strategies to replenish collections and respond nimbly to funding opportunities and maintaining appropriate staffing and articulating staffing needs based on business demands.

Session: The Recipe to Success: Building your In-house Biorepository
Speaker: Katheryn Shea, ISBER President 2012-2013; VP, Bioservices Operations, Precision Bioservice

• • Broaden your awareness of risk mitigation planning
• • Enhance your sample workflow
• • Best practices on training, maintenance and monitoring

Download the agenda to find out more about these sessions and the rest of the program.

The Biorepositories and Sample Management Event will take place September 25-27, 2013 in Boston, MA. When your register for the 6th Annual Biorepositories and Sample Management Conference, you get full access to the all-new Clinical Collaboration Congress. In addition, a colleague of yours from the Biorepositories can come to the event for free.  Also as a reader of this blog, when you register to join us and mention code XP1898BLOG, you'll save 15% off the standard rate.

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Biorepositories Session Spotlight: The Recipe to Success: Building your In-house Biorepository

There are a lot of decisions that have to be made after the initial decision to build a Biorepository in-house. Quality management of all the essential steps is essential. Design and engineering of the laboratories and storage areas associated with the Biorepository must be of the highest caliber, and the planning must take into account qualification of all systems and processes that will be applied. In this session, Katheryn Shea, VP of Bioservices Operations discusses these considerations and others including risk mitigation planning, training and competency programs and maintenance and monitoring.  Today, we're featuring the session presented by  Katheryn Shea, President, ISBER; VP, Bioservices Operations, Precision Bioservice

The Biorepositories and Sample Management Conference will take place September 25-27, 2013, in Boston.  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 standard rate.

Speaker Katheryn Shea

Featured Session: The Recipe to Success: Building your In-house Biorepository

Featured Speaker: Katheryn Shea, President, ISBER; VP, Bioservices Operations, Precision Bioservice

About the session: Building a biorepository requires sound planning from a multifaceted approach. This starts with the proper design and engineering of the laboratories and storage areas associated with the biorepository and must take into account qualification of all systems and processes that will be applied. Having a sound quality management system is essential to ensure consistency in operations.

• · Risk mitigation planning
• · Optimizing sample workflow
• · Training and competency programs
• · Maintenance and monitoring

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Could this technology effectively deliver vaccines through oral ingestion?

Researchers at Cambridge University have been working to develop a vaccine that can be universal - taken any time or any place - no matter the supply chain. They've been working on a vaccine that can survive the trip through the digestive system and make it to the small intestine where it can properly break down to deliver the active microbes to the immune system. The ultimate goal with this technology is to develop something that's needle free that can be a especially effective in developing countries. According to Bioscience Technology, as the technology goes into Phase I testing, they are looking to develop a dual vaccine for dtyphoid and enterotoxigenic Escherichia coli (ETEC).

Find out more about the technology here:

Vaccine development and production will be a main focus this year at BioProcess International. Novartis Vaccines & Diagnostics will join us to present Preparation of Highly Concentrated Influenza Vaccine for Use in Novel Delivery Approaches and Formulation of the Next Generation of Vaccine Adjuvants and Delivery Systems looking at new, innovative delivery systems that can better ensure safety and deliverability from production to the patient. For more information about these sessions and the rest of the program, download the agenda. If you'd like to join us in Boston September 16-19, 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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BioProcess International Session Spotlight: Facility of the Future – Single Use Facility, A Case Study from Biogen Idec

Single Use technologies have become widely deployed in bioprocessing and biopharmaceutical manufacturing for various applications. However, there are still a number of applications where single use technologies are not being used that offer opportunities for increase efficiency. Much more is being learned as companies test out disposable technologies and a number of practical challenges are being discovered.

This week, we profile the session Facility of the Future – Single Use Facility, A Case Study from Biogen Idec.  This session will highlight the practical experiences and lessons learned by companies who are actively trying to exploit single use technologies in their facilities and bioprocess operations. You will learn unbiased opinions about what works, what doesn’t and improvements that still need to be made to better incorporate this exciting technology for maximum benefit.

The BioProcess International Conference will take place September 16-19, 2013 in Boston, MA.  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.

Featured Session: Facility of the Future – Single Use Facility, A Case Study from Biogen Idec

Featured Speaker: Chien Lin, Senior Manager, Process Engineering, Global Project Engineering, Biogen Idec, Inc.

About the Session:  In 2012, Biogen Idec completed its first single use disposable manufacturing facility named FVM (Flexible Volume Manufacturing). This new manufacturing facility incorporated many innovative designs and seamlessly integrates operations into its existing facility in RTP (Research Triangle Park). This case study will highlight some of the design feature and intent, compare the cost of construction of this facility versus comparable traditional stainless steel facility, and finally some lessons learned from its first campaign.

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The benefits of flexible facilities

In a recent article at Pharmaceutical Manufacturing, Eric Unrau, Director of International Operations for CRB Consulting Engineers, sat down to talk some of the benefits of the new trend of creating flexible facilities when developing manufacturing facilities for pharmaceutical products.  The facilities are specifically created for the drug being made and at the requests of the Pharma companies which leads to reduced investments and faster schedules.  Due to the designed production equipment for the pharmaceuticals, product quality rises as well as a reduced risk for patients and regulatory.  When creating the facilities, CRB Consulting Engineers consider technologies, business drivers, design, quality, maintenance, safety, environmental and operations initiatives.  In the article, they take a look at how Shire pushed this envelope on taking advantage of these technologies.Read it here.

This fall at the BioProcess International Event taking place September 16-19, 2013, we'll be bringing companies including Biogen Idec, CMC Icos Biologics, Pall Life Sciencs and more together to share their insights on Flexible Facilities, Multi-product Manufacturing and Single-Use Implementation: Practical Experiences and Lessons Learned.  For more information on these sessions and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code BPI13BLOG, you'll save 20% off the standard rate!

Do you think flexible facilities will help more pharma companies move into faster production timelines?

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