Approaching Quality of Biopharmaceutical Manufacturing at the Highest Level

In today's featured interview from Biopharmaceutical Development and Production Week 2014, Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about the challenges in the bio processing industry, the systems based thinking facing the industry and knowledge management, He also looks at the challenges facing the industry, the future of regulation of continuous process validation, He also addresses how global supply chains can help the needs of the patients. Want to learn more?

Watch the interview here:


To hear more exclusive insights from biopharmaceutical production regulators, join us at the 2015 Biopharmaceutical Development and Production Week. It will take place March 30-April 2 in Huntington Beach, California. To receive updates on the program as they occur, sign up for email updates.

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Sutro's Techniques for Protein Production

In today's featured interview from Biopharmaceutical Development and Production Week 2014, Trevor J. Hallam, Ph.D., Chief Scientific Officer, Sutro Biopharma, Inc. talks about optimizing protein production. He also looks at Sutro's unique approach to creating these molecules in a system manner that produces quality products that the patients can rely on. He also addresses how the antibody drug conjugates field is evolving. Want to know more? Watch the interview here:


Find out more about Sutro Biopharma.

Biopharmaceutical Development and Production Week will take place March 30-April 2, 2015 in Huntington Beach, California. For more information on the program, sign up for email updates.

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Perspectives on Assessment, Assurance and Drug Quality: Part 2

In today's featured presentation from Biopharmaceutical Development and Production Week 2014, Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about Abbreviated License Pathway for biological products- which rely on “highly similar” FDA product on existing knowledge about the safety, purity, and potency of the reference product. He mentions that as of February 28, 2014, CDER had 62 requests for an initial meeting and how FDASIA makes it criminal to stay silent about counterfeiting or safety related issues.Baker states that the FDA has a focus on quality expectation for clinical performance.

Want to know more? Watch the interview here:


Watch Part 1.

Biopharmaceutical Development and Production Week will take place March 30-April 2, 2015 in Huntington Beach, California.  To get the latest updates on the 2015 program, sign up for email updates.

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Perspectives on Assessment, Assurance and Drug Quality

In today's featured presentation from Biopharmceutical Development and Production Week 2014, Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about the FDA’s work environment is of assurance, assessment, and assertion, the space of assertion that a company has, process validation (making an assertion and being an advocate, in a data driven way),and the many ways to look at quality by using different tools to evaluate it. Baker stated that he believes that design is about providing an experience.

Want to learn more? Watch the first part of the presentation here:


Biopharmaceutical Development and Production Week is will take place March 30-April 2. The agenda will feature more unique insights into the regulations of biopharmaceutical production so be sure to sign up to receive program updates for the 2015 agenda.

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Innovation in a Maturing Manufacturing Sector Part 2

In today's featured presentation from Biopharmaceutical Development and Production Week 2014, Tina M. Larson, Senior Director, Technical Development Operations & Engineering, Genentech, talks about four innovations in the mAb industry which include: manufacturing consistency, novel drug formats, manufacturing plant design, and drug delivery.  She states that there are two categories of improving manufacturing consistency which are process development approaches and manufacturing technology approaches. She also talks about how one of the most important technologies in the mAb field is data technology.  And one thing they use data technology for is to monitor the health processes.

Watch the Part 2 of her presentation for more information:


Watch Part 1 here.

Biopharmaceutical Development and Production Week will take place March 30-April 2 in Huntington Beach, California. Sign up to receive email updates as they become available.

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Innovation in a Maturing Manufacturing Sector

In today's featured presentation from Biopharmaceutical Development and Production Week 2014, Tina M. Larson, Senior Director, Technical Development Operations & Engineering, Genentech, talks about how the column packing robustness is still a problem in this industry. She also talks about novel formats, many ways to bispecific antibodies, and antibody drug conjugates such as Kadcyla. She also mentions ADC- a very high potency drug.She wants it to reach all of the patients around the world. Want to learn more? Watch part two of her presentation:


See Part 1 of Tina's presentation here.

Biopharmaceutical Development and Production Week will take place March 30-April 2 in Huntington Beach, California. To receive updates about next year's keynote speakers, sign up to receive the latest updates.

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Flexible Bioproduction Technologies & Facilities: Updates from the U.S. Part 2

In today's featured presentation from Biopharmaceutical Development and Production Week, Thomas Warf, Director, Manufacturing, Facilities and Engineering, BARDA, U.S. Department of Health & Human Services talks about how NOVARTIS has been with the US government since 2006, and how they are responsible for the occupancy of the new pilot facility for the first half of the year, BARDA is responsible for the 2nd half. Warf also mentions that the Chinese found a new influenza with a fatality rate of 62%-75% and how the fill and finish field is at 90% capacity. To learn more, watch the second part of Thomas Warf's presentation:


Did you miss Part 1 of Thomas Warf's presentation? Watch it here.

Are you interested in finding out more about Biopharmaceutical Development and Production Week's 2015 keynotes?  Sign up to receive email updates about the program which will take place March 30-April 2 in Huntington Beach, California.

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Flexible Bioproduction Technologies and Facilities

In today's featured presentation from Biopharmaceutical Development and Producion Week 2014, Thomas Warf, Director, Manufacturing, Facilities and Engineering, BARDA, U.S. Department of Health & Human Services talks about how the government is entering the vaccine industry. He states that the companies have to apply like the vaccine is a commercial product, and talks about how there was almost a pandemic in 2009, and how they delivered more doses of the vaccine for this pandemic than ever before.He also states that this was the first product that was approved for animal trials. To learn more watch the presentation:


Biopharmaceutical Development and Production Week 2015 will take place March 30-April 2 in Huntington Beach, California. For the latest program announcements including the call for speakers and program release, sign up for email updates.

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Complex Medicines & Global Drug Delivery

In today's featured interview from Biopharmceutical Development and Production Week 2014, Tina M. Larson, Senior Director, Technical Development Operations & Engineering, Genentech talks about the four major opportunities in the drug delivery industry, and challenges in this industry. The four major opportunities include: improving drug-delivery to improve outcomes for patients, developing more complex medicines for patients, improving facility design and improving consistency for these drugs. She states that a challenge in this industry is delivering sophisticated medicines. She also says one opportunity in this industry is to scale these medicines globally. To learn more check out this interview:



Biopharmaceutical Development and Production Week will take place March 30-April 2 in Huntington Beach, California. To stay up to date on the latest about next year's program, sign up for email updates.

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