Author Archives: BPI Staff

April Spotlight

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WHO’s Most-Wanted List: Deadliest Bacteria In February, the World Health Organization (WHO) published its first-ever list of “priority pathogens,†a catalogue of 12 families of bacteria that pose the greatest threats to human health. In particular this list highlights the threat of gram-negative bacteria that are resistant to multiple antibiotics. It is intended to guide and promote research and development (R&D) of new antibiotics. “This is a new tool to ensure R&D responds to urgent public health needs,†said Marie-Paule…

April 17, 2017

March Spotlight

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Developing Standards for Clinical Research This past fall, the nonprofit Alliance for Clinical Research Excellence and Safety (ACRES) and its partner the British Standards Institution (BSI) launched a Global Standards for Excellence (GSE) working party to develop standards for accreditation of high-performing clinical research sites around the world. The goals are to promote professionalism and excellence in clinical research; accelerate medicine development; and enhance the performance, safety, and quality of clinical trials. Sara Monday (ACRES VP of site development and…

March 20, 2017

Spotlight for February 2017

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Introducing New Editorial Advisor Jason Condon is a senior CMC project manager at Vaccinex, Inc., in Rochester, NY as well as an assistant adjunct professor in biomedical engineering at the University of Rochester. He has held roles in biopharmaceutical manufacturing and process development at Bristol Myers Squibb and Janssen R&D. His expertise in cell culture and current good manufacturing practice (CGMP) manufacturing has contributed to developing manufacturing processes for monoclonal antibody (MAb), cell therapy, and vaccine production throughout his 13-year…

February 13, 2017

Ask the Expert: Top Five Considerations in Outsourcing to a Biomanufacturing Partner

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In BPI’s 5 October 2016 webcast, Paul Jorjorian (director of global technology transfer at Patheon) discussed his top five considerations for companies outsourcing to a biomanufacturing partner. Jorjorian’s Presentation Selecting a contract and development manufacturing organization (CDMO) is an important decision for many biopharmaceutical companies. Beyond time and cost, here are some other criteria to consider. The number-one issue is quality. Is your company’s definition of quality the same as a CDMOs — and if not, how do those definitions…

February 13, 2017

Spotlight for January

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New Bioanalytical Testing Laboratory In November 2016, Sartorius Stedim Biotech (SSB) opened a new bioanalytical and biosafety testing laboratory in the biotech hub area of Boston, MA. This dedicated laboratory is designed to accommodate rising North American demand for the company’s BioOutsource specialized assay platforms and facilitate ongoing expansion of products and testing services. The company performs a range of testing for biologics, vaccines, and biosimilars throughout their development and manufacture. Reinhardt Vogt is a member of SSB’s executive committee.…

January 20, 2017

Insect Cell Culture and the Baculovirus Expression Vector System: Challenges of Scale-Up and Development

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with Sharyn Farnsworth, MSc Scale-up and manufacturing strategy for insect cell culture (ICC) should be assessed at the earliest stages of process development. Your final goals will shape the process and determine at what stage to implement steps that can make the process more reliable and robust at manufacturing scale. Only a few vendors are experienced enough to guide you through them. On 7 December 2016, Sharyn Farnsworth (associate principal scientist at Fujifilm Diosynth Biotechnologies) discussed some upstream challenges BEVS/ICC…

January 19, 2017

December Spotlight

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BPI Advisor Will Be Missed Thomas J. Pritchett, PhD (1950– 2016), was a member of the BioProcess International advisor board since its founding. He also was founder, publisher, and editor of the BioQuality Newsletter and provided decades of analytical and quality control training to many people in the biopharmaceutical industry, both on the industrial and regulatory sides. Pritchett always provided insightful, well–thoughtout approaches to implementing current good manufacturing practices (CGMPs) under all conditions, ranging from virtual to global companies. He…

December 13, 2016

The 2016 BPI Awards: Honoring the People, Organizations, and Technologies in Global Biotherapeutics

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Since 2003, the mission of BioProcess International has been to connect biopharmaceutical scientists and decision makers to the science, technology, and expertise that can positively influence and improve existing bioprocesses. Our BioProcess International Awards were created in 2012 to mark the magazine’s 10-year anniversary. They allow us to reflect on and help honor the time and investment companies put into researching, developing, and launching biopharmaceutical products, technologies, and services to deliver better, more efficient treatments and increased hope to a…

December 13, 2016

Spotlight for November

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EU Workshop Report on Authorization of Advanced Therapy Medicinal Products The European Medicines Agency (EMA) published a report from a multi-stakeholder expert meeting held in May exploring ways to foster the development of ATMPs in Europe and expand patients’ access to these new treatments. ATMPs comprise gene therapies, tissue-engineered products, and somatic cell therapies. These medicines have the potential to reshape treatments of a wide range of conditions, particularly in diseases for which conventional approaches are inadequate. However, eight years…

November 14, 2016

Ask the Expert: Top Five Considerations in Outsourcing to a Biomanufacturing Partner

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    with Paul Jorjorian In BPI’s 5 October 2016 webcast, Paul Jorjorian (director of global technology transfer at Patheon) discussed his top five considerations for companies outsourcing to a biomanufacturing partner. Jorjorian’s Presentation Selecting a contract and development manufacturing organization (CDMO) is an important decision for many biopharmaceutical companies. Beyond time and cost, here are some other criteria to consider. The number-one issue is quality. Is your company’s definition of quality the same as a CDMOs — and if…

November 14, 2016