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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10 Solutions to Drive Efficiencies in Your Bioprocesses

For 10 years running, BioProcess International has been recognized as the #1 bioprocessing industry event. It is where the industry connects each year to share technical, scientific and strategic solutions across all phases of BioProcess development.  This year, it will take place September 16-19, 2013 in Boston, MA.

What are the 10 Solutions to help you improve integration, productivity and flexibility you can gain at BioProcessing International?

1. Overcome production challenges of more complex molecules, beyond mAbs, currently emerging in the industry pipeline
2. Prepare your offensive or defensive strategy for the imminent wave of biosimilar products
3. Manage the development challenges of multiple compounds to increase production throughout and success rates
4. Develop more flexible processes and capabilities in both stainless-steel and single-use facilities for more versatile manufacturing operations
5. Leverage new technologies for efficient development, manufacturing and cost reductions
6. Improve integration and efficiency at process interfaces from discovery to development to production
7. Modify fixed facilities with flexible capabilities to keep pace with evolving product pipelines
8. Maximize throughput of higher titer processes and cell culture intensification
9. Improve efficiency, speed and quality in upstream and downstream development
10. Streamline operations and eliminate waste with continuous processing and improvement principles 

In addition, you have access to meet with the leaders in industry with more than 200 speakers and 150+ exhibitors and 1500+ attendees. There is no other bioprocessing event that can compare to the content, networking and business opportunities.

Download the agenda to find out all the BPI Event has to offer.

If you'd like to join us at BioProcess International, as a reader of this blog, when you register to join us and mention code BPI13BLOG to receive maximum savings of $500 off the standard rate!  If you have any questions about the event, feel free to email Jennifer Pereira.

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Biorepositories Session Spotlight: Meeting the Biospecimen Management Challenges of the Coming Decade and Beyond

The end goal for any organization working in biopharmaceuticals is to maintain high quality biospecimens for research, clinical trials and patient diagnosis. While a great deal of progress has been made in the last decade in biospecimen management, there is still a ways to go, especially as new technologies emerge and the biopharma industry tries to standardize their processes. In today's featured session, keynote Helen Moore, Program Director for NCI’s Biorepositories and Biospecimen Research Branch discusses this and other challenges such as new understandings about patient de-identification and informed consent and building robust systems for management of biospecimen lifecycle data.

The Biorepositories and Sample Management Conference 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.  If you'd like to join us in Boston, as a reader of this blog when you register to join us and mention code XP1898BLOG, you'll save 15% off the standard rate.

Keynote Helen Moore

Featured Session:  Meeting the Biospecimen Management Challenges of the Coming Decade and Beyond

Featured Speaker: Helen Moore, Program Director, NCI-BBRB

About the session: A great deal of progress has been made over the last decade in biospecimen management. However, significant challenges remain and must be addressed in order to ensure that high quality biospecimens are available for research, clinical trials, and patient diagnosis.

• • Incorporating new understandings about patient deidentification and informed consent into biospecimen management practices
• • Building the foundation of knowledge in Biospecimen Science
• • Applying new knowledge to the development of common biospecimen management standards
• • Building robust systems for management of biospecimen lifecycle data and donor clinical data

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How can biorepositories accelerate clinical trials?

The Moffitt Cancer Center of Tampa, Florida has taken a huge step in creating effective efforts to make patient recruitment easier and have quicker, more successful clinical trials. How? They've created a biorepository that archives and details biological samples provided by patients already being treated. To collect samples, they encourage their patients to donate their tumor tissue and other biological samples through the Total Cancer Care© protocol.

According to the Oncology Nurse Advisor, after donation their samples are analyzed, biomarkers are noted and the information is kept in electronic health records. With this precision, the importance of the well kept and ordered biorepository is proven by helping those conducting clinical trials to reduce the patient trial size, conduct them faster due to the help of the analysis that aids personalized medicine.

According to David Fenstermacher, PhD, also Moffitt Cancer Center, “Our study provides evidence that programs, such as the Total Cancer Care® protocol, that follow patients and collect clinical data for storage in a common warehouse can reduce the number of patients needed for a clinical trial without compromising the results of the study. Another positive impact of using the biorepository for clinical trial participation is that phase II trials that test new cancer treatments being developed by the pharmaceutical industry move more quickly and cost less.”

A major issue in the current biorepositories industry is that it is difficult to keep track of and provide storage for samples in an efficient way. What other progress has been made in the field?  This fall at the Biorepositories and Sample Management event, Helen Moore, Program Director, NCI-BBRB will be joining us to address some of the other progress that has been made in the sample management field during the presentation Meeting the Biospecimen Management Challenges of the Coming Decade and Beyond. For more information on this event, download the agenda. If you'd like to join us September 25-27, 2013 in Boston, 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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Agenda Now Available: IIR's BioRepositories and Sample Management Conference

IIR's 6th Annual Biorepositories and Sample Management Conference is the largest US-event where you come to harness, protect, and grow the value that lies in your samples. We do this through detailed case studies and expert insight into those areas that present the greatest challenges to your business, including how to:

• • Develop harmonized standards to overcome the challenge of sample access
• • Understand current regulatory guidelines - or lack thereof - that affect your day-to-day functions
• • Examine how quality factors in to the evolution of evidence-based Biobanking
• • Determine whether building your own Biorepository or outsourcing to a vendor is the best choice for your company

Download the brochure to view the full agenda.

The Biorepositories and Sample Management Conference will take place September 25-27, 2013 in Boston, MA. Your registration also grants you access to our co-located event, Clinical Collaboration Congress. If you’d like to join us, as a member of this group, you’ll save 15% off the standard rate when you register to join us and mention code XP1898BLOG. This year, we’re also offering a second free delegate pass to a biorepository or biobank participants with the purchase of each pass. For more information on this offer, read here. If you have any questions, feel free to email Jennifer Pereira.

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Rutgers University completes renovations on largest academic biobank

Rutgers has completed renovations on one of the world's largest university-driven biobanks. As chosen by the NIH, it is one of four institutions that will provide sample processing, analysis, storage, and data management for research projects. A recent Rutgers release states that the biobank features the new Genomics Technology Center. It will serve government agencies, foundations, and private-sector clients worldwide, including major pharmaceutical companies.  The University's biobank is already known for the advances it has made in mental disorders and addictions.

Andrew I. Brooks, Chief Operating Officer, Director of Technology Development and Rutgers associate research professor of genetics stated, "We’ve integrated our operation to make us more efficient, thereby increasing our capacity so we can better serve NIH-funded researchers but also to make our services more available to the private sector. We’ve expanded out infrastructure and doubled our automation analytical capabilities. Our goal is to standardize biosample collection, processing, distribution, and analysis to facilitate and accelerate the disease-discovery process.”

While institutions like Rutgers continue to make strides, the Biorepository industry as a whole is still in need of guidance to push progress forward. Our fall conference, Biorepositories and Sample Management Conference, brings together Industry Standardization Workgroup featuring participants Amelia Wall Warner, Head, Clinical Pharmacogenomics, Merck; Anita Nelsen, Head, R&D Human Sample Repository, GlaxoSmithKline; Helen Moore, Program Director, NCI-BBRB; Lori Ball, COO, Biostorage Technologies; and Katheryn Shea, President, ISBER; VP, Bioservices Operations, Precision Bioservice. During this afternoon session, the panelists and attendees will meet together to discuss Regulatory trends in patient privacy of biospecimens, Bioethical issues, Standardization of samples, Consent and re-consent, Return of research results to patients and more. For more information on this workgroup and the rest of the event, download the agenda here. If you'd like to join us in Boston September 25-27, 2013, a a reader of this blog, when you register to join us and mention code XP1898BLOG, you'll save 15% off the standard rate.

How important is it that we develop industry standards for the biobanking sector?

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Just Released: Formulation & Delivery Conference Agenda

We’re pleased to announce the release of IBC’s 13th Annual Formulation & Delivery Strategies for Biologics and Protein Therapeutics taking place this September.

Download the agenda here.

Conference sessions provide predictive methods and innovative technologies for the rational development, production and delivery of next-generation biologics and protein therapeutics:

• - Particle Identification and Characterization for Realizing Stable, Safe and Effective Formulation
• - Analytical Strategies for Determining Formulation Stability
• - Biosimilar Formulation and QbD Considerations for Biologic Development
• - Localized and Targeted Delivery Strategies
• And more!

This event will take place September 17-19, 2013 at the Hynes Convention Center in Boston, Massachusetts. It is co-located with the BioProcess International Conference & Exhibition. As a member of this group, when you register to join us and mention code B13166JP, you’ll save 20% of the standard rate. If you have any questions, feel free to email Jennifer Pereira.

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Utilizing Design of Experiments (DOE) for Characterizing Assay Robustness during Drug Development

Kyra J. Cowan, Ph.D., Scientist, Genentech, Inc, and presenter at next week's Development, Validation and Maintenance of Biological Assays recently sat down with us to preview her presentation.  For more information on the event, download the agenda.  If you'd like to join us next week in Seattle, as a reader of this blog when you register to join us and mention code IBA13JP, you'll save 20% off the standard rate.

Your abstract states that you identified factors which impacted assay performance utilizing a screening DOE design. Once you have identified these factors do you then utilize the response surface mapping DOE designs to determine appropriate ranges?

We used a 24-run Plackett-Burman screening design to economically model all main effects and all ten 2-way interactions that may impact the response, and these factors and their corresponding levels that were included in this robustness DOE were selected based on prior knowledge of the assay and the acceptance criteria for the assay (Cowan KJ et al., Bioanalysis 4(17), 2127-39 (2012)). A response surface mapping DOE to determine appropriate ranges could have been used, in particular to further define the optimal coat concentration (for example) for this study, however we chose not to run this because we clearly saw the impact of having an unstable ligand, which was the source of the lack of robustness for this assay, and that only by handling the ligand under specific conditions could we rely on the method.

Assay robustness is a common analytical development step to utilize DOE approaches. Do you use DOE for any other development steps? If so which ones?

We can and have in some instances employed DOE to initiate assessment of reagent conditions and assay parameters at the beginning of the development stages of an assay (eg. for assay optimization), whether it’s a PK or an ATA assay, to efficiently assess the levels of the critical factors (such as coat concentration, minimum dilution of matrix, and detection reagent concentration). Some have found this to be a useful step in accelerating assay development, to assess assay robustness, or in new reagent validation.

 Many of our conference attendees are developing cell-based bioassays. Can you envision using the same DOE approach for a cell-based assay instead of a Ligand Binding Assay and what would be the additional challenges?

 As with all DOEs, the critical step is to determine which factors (and their levels) need to be assessed, since this design was meant to be a fit-for-purpose DOE and the factors will define the effectiveness of the DOE. The factors selected to be analyzed, and in turn the output or response of the DOE, should reflect the experience of the assay developer during development. This particular Plackett-Burman design used in the presentation was originally designed so that it could also incorporate not only coating conditions and substrate development time, but different lots of matrix and detection lots and their concentrations. For a cell-based assay robustness DOE, additional or alternative factors that could be included in the design that may change in small increments over time could be cell seeding density, cell harvest density, cell age, and both assay and detector (eg. Alamar Blue) incubation times, and the 2 levels for each of these factors could be the predicted or potential small variations on the final conditions selected for that cell-based assay. A recent paper by Xinyi C. Chen et al (2012) implemented DOE in the development and validation of a cell-based assay and describes a fractional factorial design to address some of these issues (Chen XC et al., J. Immnunol. Met. 376, 32-45 (2012)).

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A deeper look at Flublok - the egg free vaccine

Recently, we invited Manon M.J. Cox, President and CEO, Protein Sciences Corporation to sit down with us before the Vaccines Development and Production Summit to give us a preview of the flu vaccine industry, what challenges their facing and the remarkable technology her company has developed in order to stand apart in the flu vaccine industry.

During the podcast, she discusses the difference between Flublok and other vaccines and the current perception of receiving a flu vaccine by many adults.  She also looks at the current influenza outbrake,t hat of H7N9 and how they've developed a plan to combat it with a vaccine.

Listen to the podcast here.

Manon will be joining us at the Vaccines Development and Production Summit this June 3-5, 2013 in Durham, North Carolina.  For more information on her presentation Flublok®: Developing the World’s First Recombinant, Highly Purified, Egg-Free Influenza Vaccine and the rest of the program, download the agenda. As a reader of this blog when you register to join us and mention B13187SPX32, you'll save 20% off the standard rate. If you have any questiosn, feel free to reach out to Jennifer Pereira.

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Vaccines Session Spotlight: Influenza Vaccines for Pandemic Preparedness and the Future and the World’s First Egg-Free Vaccine

Pandemic preparedness is a regulatory and industry effort. Today we feature two of the sessions at Vaccines Development and Production Summit.  You can  hear from the latest U.S. Department of Health and Human Services efforts from Keynote Presenter Robert C. Huebner, Ph.D., Acting Director, Influenza Division, HHS/ASPR/BARDA.  We'll also be joined by Manon M.J. Cox, President and CEO, Protein Sciences Corporation, who developed the  the novel technology Flublok.  It was also  the worlds’ first recombinant, highly purified, egg-free influenza vaccine and it successively navigated the regulatory pathway of the FDA.

The Vaccines Development and Production Summit will take place June 3-5, 2013 in Durham, North Carolina. For more information the featured sessions and the rest of the agenda, download the program.  If you'd like to join us, as a reader of this blog when you register to join us and mention code B13187SPX32, you'll save 20% off the standard rate.

Featured Sessions:

Development of New Influenza Vaccines for Pandemic Preparedness and the Future
Featured Speaker: Robert C. Huebner, Ph.D., Acting Director Influenza Division, HHS/ASPR/BARDA
About the presentation: Since 2004, BARDA has supported the nation’s pandemic preparedness and the technology use for seasonal and pandemic influenza vaccine production. This talk reviews the progress of the current BARDA programs and discusses future efforts to meet the nation’s needs for seasonal and pandemic influenza vaccines.


Flublok®: Developing the World’s First Recombinant, Highly Purified, Egg-Free Influenza Vaccine
Featured Speaker: Manon M.J. Cox, President and CEO, Protein Sciences Corporation
About the presentation:This presentation explores the novel manufacturing technology and regulatory pathway of Flublok, which the FDA regards as a technological advance in the manufacturing of an influenza vaccine. This keynote examines the departure from using the virus and eggs in production and how the process allows for the rapid production of large quantities of the influenza virus protein, hemagglutinin (HA), using a baculovirus expression system.

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BPI China Spotlight: Adjustment of Critical Quality Attribute (CQA) by Multivariate Analysis (MVA) in Biosimilar Media Supplement Development

Recently, we had the opportunity to sit down with H. Fai Poon, M.D., Ph.D., Director of Cell Culture, Hisun Pharmaceutical (Hangzhou) Co., Ltd., China to discuss his background and experience with cell cultures and biosimilar development. During the podcast, he discusses his background, his company, and what he will be addressing at BioProcess International China taking place August 20-21 in Shanghai.

On Tuesday, April 20, Dr. Poon will be presenting the case study Adjustment of Critical Quality Attribute (CQA) by Multivariate Analysis (MVA) in Biosimilar Media Supplement Development.  Quality by Design (QbD) is the approach towards development and commercialization of biologics. In QbD, the process is designed and controlled to deliver critical quality attributes (CQA) consistently. Such process controls are particularly important for biosimilar development since they are required to demonstrate CQA similarity to reference drugs. We present a case study here that we applied multivariate analysis (MVA) to adjust the CQA of a biosimilar drug. CQA of a biosimilar product was adjusted to the reference drug criteria by cell culture media supplement optimization using MVA. Moreover, such optimization resulted in a more robust biomanufacturing process.

For more information on this session and the rest of the program, download the agenda.  If you'd like to join us in Shanghai, as a reader of this blog when you register to join us and mention code BPIC13JP, you'll save 20% off the standard rate.  Have any questions? Email Jennifer Pereira.

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Human Factors Session Spotlight: Linking HF to Clinical Trials – Can Clinical Trials Be a Source of Human Factors Information, or Not?

Clinical studies on the drug component of many drug-device combination products are conducted simultaneously, yet independently of the human factors studies. If there is a delay on one of these studies, the market launch of the combination product can be delayed.  This May in Bethesda, Maryland, experts from P/L Biomedical, MannKind Corporation and Hospira gather to discuss the  interface between the clinical drug study and the human factors device study to see where there are opportunities for greater synergy and efficiency.

The Human Factors for Drug-Device Combination Products Summit will take place May 14-15, 2013.  For more information on this session and the rest of the agenda, download the brochure.  If you'd like to join us in Maryland, as a reader of this blog when you register to join us and mention code HFJP13, you'l save 20% off the standard rate!

Featured Session: Linking HF to Clinical Trials – Can Clinical Trials Be a Source of Human Factors Information, or Not?

Participants:
Moderator: Lee H. Leichter, RAC, MBA, President, P/L Biomedical
Panelists: Chad Smutney, Senior Director, Device Technology, MannKind Corporation
Seema Kumbhat, MD., Medical Director, Drug Device Development, Hospira

About the session:
• How are clinical studies affected? Should they be conducted at the same time as when you’re conducting HF usability studies?
• What data can/cannot be collected effectively in a clinical trial?
• Can you link clinical trials to human factors studies to come up with elements during trials to show that you’ve probed patient user usage and that residual error is acceptable?
• Medical / clinical perspective on leading human factors programs at corporations: strengths/pitfalls

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Flu vaccines and the egg allergy - is there finally a solution?

The flu vaccine has become a staple in the United States - The Bolus cites several reasons including expanded access and improved awareness and education.  But there is currently a small portion of potential individuals who can't revive the current flu vaccine - those who are allergic to eggs.  However, recently the FDA has approved two types of egg-free vaccines including Flucelvex and Flublok for adults over the age of 18.  These two procedures have found alternative ways that can leave chicken embryo fluid out of the vaccine development process.

This coming June at the Vaccines Development and Production Event, Manon M.J. Cox, President and CEO, Protein Sciences Corporation, will be on hand to discuss the development of Flublok®.  For more information on Manon's presentation, download the agenda.  If you'd like to join us June 3-5 in Durham, North Carolina, as a reader of this blog when you register to join us and mention code VDPS13JP, you'll save 20% off the standard rate!

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Eppendorf develops new single-use bioreactor

Eppendorf has developed the first single-use bioreactor for
microbial applications.

According to BioResearch Online:

The BioBLU 0.3f joins the BioBLU 0.3c which was presented last year and is designed for the cultivation of animal and human cells. Both the BioBLU 0.3c and BioBLU 0.3f are specifically designed for use with the compact DASbox mini bioreactor system. Eppendorf’s DASbox system is a unique mini bioreactor system for parallel operation of 4, 8 or more mini-bioreactors and well suited for Design of Experiment (DoE), bioprocess development screening and for use as a scaledown model. With the new BioBLU 0.3f, Eppendorf is paving the way for users of conventional microbial-based biotechnology to take advantage of, the time and cost benefits of single-use bioreactor technology, such as in pharmaceutical product development.

To learn more about Disposable Probes and Sensors? We'll have Alan Opper, Eastern Regional Manager of Finesse Solutions on hand to present Building Flexibility into Bio-Processing: Turn-Key Bioreactor Control Systems for Both cGMP and Non-GMP Applications and Kamal Rashid, Ph.D., Associate Director, Research Professor of Utah State University to present A Comparative Study of Stirred-Tank Bioreactors: Reusable (Glass) vs. Single-Use (New Brunswick CelliGen® BLU) at the upcoming Single-Use Applications for Biopharmaceutical Manufacturing Summit taking place June 3-5, 2013 in Durham,North Carolina. If you'd like to find out more about these presentations, 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 SU13JP to save 20% off the standard rate.

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Single Use Session Spotlight: Single-Use Process Fit for mAb Production

Applying single-use technology has shown to lower costs and increase yield. How? Merck & Co., Inc. completed an end-to-end process fit using single-used technology for the production of monoclonal antibodies. Gain insights on single-use technology versus traditional stainless steel for process fits and facility designs. Dr. Jeffrey Johnson will be joining us at the Single-Use Applications Summit for Biopharmaceutical Manufacturing to present Single-Use Process Fit for mAb Production this June in Durham, North Carolina.

For more information on this session and the rest of the program, download the agenda. If you'd like to join us June 3-5, 2013, in Durham, North Carolina, as a reader of this blog when you register to join us and mention code SU13JP, you'll save 20% off the standard rate!

Featured Session:  Single-Use Process Fit for mAb Production

Featured Speaker: Jeffrey Johnson, MS, New Technology Lead, Merck & Co

About the session: A complete process fit for end to end single use production of monoclonal antibodies will be presented. The evaluation includes a comparison of stainless steel and SU facilities, with capital estimates and total cost of ownership assessments, and NPV modeling. Sensitivity analysis will be demonstrated using single use equipment evaluated at lab or pilot scale. This in depth evaluation will provide insight into single use vs. traditional stainless steel process fits and facility designs.

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