Author Archives: Alison Center

Monoclonal Antibodies: Beyond the Platform in Manufacturing

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The vast majority of monoclonal antibody (MAb) production processes are based on fed-batch Chinese hamster ovary (CHO) cell culture and protein A affinity column chromatography capture. Increasing cost-consciousness — among innovator companies as well as biosimilar makers — has many companies looking “beyond the platform†for less expensive alternatives that may provide better results. Here the BPI editors review some state-of-the-art alternatives in upstream and downstream MAb drug substance bioprocessing as well as drug-product manufacturing. The current “gold standard†platform…

March 29, 2019

Continuous Chromatography: Experts Weigh in on the Possibilities and the Reality

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Discussions of continuous processing in the biopharmaceutical industry are an important part of current efforts toward intensifying bioproduction and bioprocessing. Biomanufacturers are looking at all components of their development and manufacturing processes for ways to reduce the size of their facilities, lower costs, and increase speed and flexibility of operations. Increasing options for and availability of single-use technologies have been major enablers of myriad attempts to improve efficiencies. Although the general consensus may still be that single-use components are more…

February 28, 2019

Messenger RNA Drugs: Engaging the Machinery of Patients’ Cells to Therapeutic Effect

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Although most of the bioprocess industry has focused on process development for large-molecule formulations (e.g., protein drugs), a growing segment of the industry has been concentrated on other types of biotherapeutics to leverage advances in understanding of immunology and genetic engineering. Such technologies may emerge both as tools for drug manufacturing and at some point, as biopharmaceuticals, biotherapeutics, vaccines, and cell and gene therapies,  themselves. What brings mRNA research to BioProcess International’s attention is the increasing interest turned toward therapeutic…

December 22, 2018

Innovators and Biosimilar Companies: Experts Predict Intense Conflicts Ahead

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CPhI Worldwide (organized by UBM) announced last fall the final section findings of the fifth edition of the CPhI Annual Report. Presented live at the meeting in Frankfurt, Germany, the report is now available online. It highlights immediate and long-term trends in pharmaceutical data, regulation, generics, and biosimilars. Four experts gave their views. They warned that the US Food and Drug Administration’s (FDA) approach to achieving six-sigma (nearly perfect or 99.9997% defect-free) quality is failing in respect to the pharmaceutical…

June 20, 2018

Facilities of the Future: Intelligent Design and Control Enable Quality, Efficiency, and Good Citizenship

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Today’s biomanufacturers need to be able to add capacity and capability quickly; provide increased supply service to customers on demand; and streamline the flows of personnel, traffic, utilities, and materials throughout bioprocess facilities. And companies need to be flexible enough to subtract capacity and retool quickly to produce new or different products. Many future facilities will be automated to some extent and use robotics in manufacturing. With personalized medicine on the rise, bioprocessors can benefit from colocation with academic research…

April 20, 2018

Panel Discussion: Emerging Biotherapies and Their Manufacturing Challenges

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At noon on Tuesday, 20 June 2017, BioProcess International presented a panel discussion as part of the “Emerging Therapies†session of its BPI Theater at the Biotechnology Innovation Organization’s annual convention in San Diego. Moderated by Patricia Seymour (senior consultant at BioProcess Technology Consultants), this panel comprised Holger Wesche (vice president of research at Harpoon Therapeutics), Richard Snyder (chief scientific officer of Brammer Bio), Marc Better (vice president of product sciences at Kite Pharma), and Paulo Carvalho (associate director of…

August 8, 2017

Panel Discussion: How CMO Business Models Have Adapted to Meet the Challenges and Opportunities of Protein-Based and Emerging Therapy Markets

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On Tuesday, 20 June 2017, BioProcess International presented a panel discussion from 1:20 to 2:00 pm as part of the “Emerging Therapies†session of its BPI Theater at the BIO annual convention in San Diego. Moderated by Gil Roth (president of the Pharma and Biopharma Outsourcing Association), the panel comprised John Foy (vice president of business management for biologics at Patheon), Michael A. Riley (vice president and general manager of Catalent Biologics), Victor Vinci (vice president and chief scientific officer…

August 7, 2017

Panel Discussion: Cell, Gene, and Tissue Therapies — Applying Key Lessons from the Evolution and Commercialization of Protein-Based Therapies

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On Tuesday, 20 June 2017, BioProcess International presented a panel discussion from 2:20 to 3:30 pm as part of the “Emerging Therapies†session of its BPI Theater at the BIO annual convention in San Diego. Moderated by David Brindley (University of Oxford and Harvard University), the panel comprised Morrie Ruffin (managing partner of the Alliance for Regenerative Medicine), David Backer (head of commercial development for gene editing and novel modalities at MilliporeSigma), Robert Preti (president and chief executive officer of…

August 7, 2017

Panel Discussion: Process and Business Considerations for Innovation — Supplier and End-User Perspectives

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On Wednesday, 21 June 2017, BioProcess International presented a panel discussion from 11:00 am to 12:00 pm as part of the “Emerging Techniques and Technologies†session of its BPI Theater at the BIO annual convention in San Diego. Moderated by Tom Ransohoff (vice president of BioProcess Technology Consultants), the panel comprised Stewart McNaull (senior vice president of business development at KBI Biopharma), Bernard Huyghe (senior director at Pfizer), John Bonham-Carter (director at Repligen, not pictured), and Todd J. Menkhaus (cofounder of…

August 7, 2017

Panel Discussion: Single-Use and Process Development Technologies — Making the Right Choices for Your Process

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At noon on Wednesday, 21 June 2017, BioProcess International presented a panel discussion as part of the “Emerging Techniques and Technologies†session of its BPI Theater at the BIO annual convention in San Diego. Moderated by Susan Dexter (managing director of Latham Biopharm Group), this panel comprised Deborah Harris (vice president of operations at Abzena), Magnus Schroeder (director of downstream process development at CMC Biologics), and Stephen Lam (vice president of operations at Patheon). There is no debate: Single-use technologies…

August 7, 2017