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Identification of Process Parameters Which Underpin Robust Platform Production Processes

by Maxime Rantz, Leon Pybus, Kayleigh Coxon and Simon Uphill

Critical objectives for the biopharmaceutical industry are the creation of robust, reproducible processes which result in consistent critical product quality attributes and yields. To meet these requirements within a short time period it is important to apply platform production processes which consist of a common host cell line, expression vector, cell line development process, cell culture media/feed, process control and scale-up methodologies during cell line development, process characterization and cGMP manufacturing. In this study we integrate mathematical based approaches with…

Collaborating to Address the Bioburden Challenge

by Anders Ljunglof, David Westman, Anna Gronberg, Elin Monie, Tomas Bjorkman, Magnus Wetterhall, Johan Avallin and Josefin Bolik

Bacteria and their byproducts can negatively affect the safety and potency of a biopharmaceutical drug. At a minimum, bioburden contaminations lead to reduced productivity as a result of lost batches and/or deviation investigations. Striving towards a bioburden-free process, biopharmaceutical companies and their suppliers must collaborate. To meet this challenge, GE Healthcare is committed to continuous improvement of its chromatography resins to enable delivery of products without detectable bioburden. For example, development of Protein A resins to withstand high NaOH concentrations…

Purification of Antibody Fragments with Amsphere™ A3 Protein A Resin

by Guido Strohlein, Gerald Platteau, Bob Van der Jeugt, Vaiva Gaspariunaite, Cecile Vincke, Yann Sterckx and Serge Muyldermans

The binding mechanism between the engineered C domain of the Amsphere™ A3 protein A (PrA) ligand and a VHH single domain antibody (sdAb) was revealed. Binding sites in the PrA ligand in helices 2 and 3 and in framework regions 1 and 3 of the VHH were confirmed. Identified VHH residues are not involved in antigen recognition. Overlap with a human VH showed the same interaction sites. These results provide insight on why Amsphere A3 is a suitable tool for…

Modular, Single-Use Facilities Increase Biomanufacturing Flexibility

by BPI Contributor

The pipelines of biopharmaceutical companies are becoming increasingly diverse while improvements in cell lines are leading to more productive bioprocesses. These factors are driving new capacity demands for bio-pharmaceutical companies and their CDMO partners. It is becoming increasingly important, therefore, that companies implement innovative, highly efficient, flexible facilities that are capable of meeting these challenging capacity demands. Login to view full PDF version of poster.

Panel Discussion: Emerging Biotherapies and Their Manufacturing Challenges

by Alison Center

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…

New Tools to Improve Cell Viability, Purity, and Recovery

by BPI Staff and Sean Kevlahan

Presented by Sean Kevlahan (chief executive officer, Quad Technologies) 11:00–11:20 am Kevlahan described Quad Technologies as an early stage company founded in 2013 and headquartered in Woburn, MA. Its approach to cell and gene therapies is offering bioprocessing tools with a biomaterials focus. The company’s QuikGel platform is a hydrogel-based technology for making different sizes of hydrogel microbeads that will dissolve under gentle conditions. The beads can be magnetic or nonmagnetic for both research and bioprocessing applications. This technology provides Quad…

Advanced Therapies Capabilities at FDBT

by BPI Staff and Yan Zhi

Presented by Yan Zhi (program design technical lead, Fujifilm Diosynth Biotechnologies) 11:20–11:40 am Fujifilm Diosynth Biotechnologies Texas (FDBT) has two dedicated viral products facilities: The National Center for Therapeutic Manufacturing (NCTM) building was designed for process development and early phase clinical good manufacturing practice (GMP) production of advanced therapeutics including viral, microbial, and plasmid products. The newly built Flexible Biomanufacturing Facility (FBF) is designed for clinical and commercial GMP production of viral products. The NCTM boasts 14 first- and second-generation mobile…

Covering a Spectrum of New Product Development Technologies: From Cells to Cell Therapy

by BPI Staff and Stewart McNaull

Presented by Stewart McNaull (senior vice president of business development, KBI Biopharma) 11:40 am–12:00 pm Founded in 2004, KBI Biopharma operates a core facility in Durham, NC. In 2013, the company needed more space and set up laboratories in Research Triangle Park, NC. Using mammalian cell lines, it has developed both monoclonal antibody (MAb) and non-MAb platforms. It acquired a former Merck site in Boulder, CO, in 2014 and retained staff experts in fermentation expression, refolding, and mass spectrometry. With manufacturing…

Navigating the Road to Commercialization Together

by BPI Staff and Cyril Peter

Presented by Cyril Peter (senior proposal manager, Lonza Pharma and Biotech) 1:00–1:20 pm A publicly traded company, Lonza focuses on drug sponsors that want to go to market with their own products. “To get there, you need to make a drug out of your molecule, manufacture it, go through clinical trials, and generate data for submission to regulatory authorities for market authorization.” That requires information about the molecule (critical quality attributes, CQAs) and on how you make it (critical process parameters,…

Increasing Cell Productivity and Quality in MAb Production By Focusing on a Novel Target

by BPI Staff and Adam Elhofy

Presented by Adam Elhofy (chief science officer, Bio-Ess Laboratories) 2:00–2:20 pm “What we call biomanufacturing,” said Elhofy, “is all about cells. When cells get cranked up, they start to have deficiencies — and those deficiencies lead to different protein quality, to aggregates, and to a loss of consistency in protein quality. So how do you improve productivity and protein quality?” Bio-Ess Laboratories (formerly Essential Pharmaceuticals) has a technology to address the role that lipids play in cell productivity. The company has…