2021

Your Partner for Host Cell Protein Analytics for Over 25 Years

Cygnus Technologies, part of Maravai LifeSciences, is the biopharmaceutical industry’s partner in host cell protein (HCP) and other process-related impurity detection and analytics. In addition, Cygnus now provides innovative viral clearance solutions. Cygnus helps companies developing therapeutic proteins, vaccines, antibodies, plasma derivatives, and gene therapies ensure the safety of their biotherapeutics before human trials, regulatory approval, and commercial release. Cygnus provides analytical tools and solutions for improving bioprocess development for faster regulatory approval and better clinical outcomes. Cygnus is an…

Achieve Best-in-Class Purification with the Avantor J.T.Baker BAKERBOND PROchievA Resin

There is an established, global pipeline of existing and upcoming monoclonal antibody (MAb) drugs that treat a wide variety of clinical indications. In MAb manufacturing, protein A chromatography is a proven downstream purification process, but there remains a need to reduce total costs while improving purity and yield. The Avantor J.T.Baker BAKERBOND PROchievA recombinant protein A chromatography resin advances the production of MAbs by providing different choices to biopharmaceutical supply chains. Offered both as a bulk resin and as prepackaged…

Scalable, Real-Time Bioprocess Monitoring Solution: Kaiser Raman Technology and Sartorius BioPAT Spectro Yield Value from Early Process Development to Single-Use Manufacturing

Raman spectroscopy is used in biomanufacturing as a process analytical technology (PAT) tool for making rapid, nondestructive, in-process measurements. However, Raman data collection at early stages of bioprocess development has been a challenge because of the lack of interface to bioreactors <250 mL. Realizing the industry was struggling to capitalize on the full potential of Raman spectroscopy, Kaiser Optical Systems, Inc. (Kaiser), an Endress+Hauser company, collaborated with Sartorius to bring Raman to Ambr 15 microbioreactors (10–15 mL) and Ambr 250…

Take Complexity and Risk Out of Regulatory Compliance

Novo Nordisk Pharmatech’s high-purity, nontherapeutic insulin is sourced directly from the Novo Nordisk parent company, the world’s largest insulin producer. The product consists of insulin human crystals that are biosynthetically produced by recombinant microbial expression in yeast. Insulin human AF stimulates the proliferation of cells and enhances the yield, and it is a key component in serum-free growth media for mammalian cells. Insulin human AF is used for manufacturing monoclonal antibodies, virus vaccines, gene therapies, and other biological drug products…

eBook: Process-Related Impurities — Emerging Strategies for Detection, Identification, and Management of Host-Cell Proteins

Host-cell proteins (HCPs) represent a major class of process-related impurities (PRIs) that are generated during biopharmaceutical manufacture. Although the vast majority of such proteins are removed from a drug substance during downstream purification, residual HCPs can remain in a finished drug product. Even in minimal concentrations, copurifying HCPs can pose safety risks and compromise protein-product yield, efficacy, and stability. Thus, regulatory agencies consider the presence of HCPs to be a critical quality attribute (CQA). Sufficient clearance of these impurities helps…

Contractor Perspectives: Best Practices for Transfer, Handling, Testing, and Storage of Cell Banks

For comments about how contract development and manufacturing organizations (CDMOs) manage their cell-banking quality assurance (QA) practices. I contacted long-time member of BPI’s Editorial Advisory Board Scott M. Wheelwright, PhD, for his perspectives. Wheelwright brings many years of experience to this discussion, with insights into the evolution of technologies and practices extending back to the early launch of the biopharmaceutical industry. Currently, he provides consulting support for companies with manufacturing and sourcing in China and other Asian countries. He also…

June 2021: From the Editor

We’ve reached midyear 2021 and our last regular issue until September. You will receive our annual Innovators issue in August. Along with it will be the (also yearly) featured report summarizing presentations from the BPI Theater at the Biotechnology Innovation Organization (BIO) International Convention. BPI strives to maintain a balance of thought leadership from different groups in the industry ecosystem: end users, academic researchers, suppliers, contractors, regulators, and consultants. And we focus on specific bioprocesses for each product modality —…

Mesenchymal Stromal Stem Cells: Next Steps and Considerations for CGMP Manufacturing

Massimo Dominici is scientific founder of Rigenerand srl, a joint venture between RanD (a biomedical company producing bioreactors for liver support and chemohyperthermic technology for cancer) and experts in cell and gene therapy at the University of Modena and Emilia Region in Italy. Rigenerand develops and manufactures medicinal products for cell-therapy applications (primarily for regenerative medicine and oncology) and three-dimensional (3D) bioreactors as an alternative to animal testing for preclinical investigations. The company also produces its own pipeline of cell…

Raw Materials for Advanced Therapies: When the Process Is the Product, Ingredients Are Key

Scott Burger and Bill Janssen are both established, independent consultants specializing in gene and cell therapies. This past spring, we three discussed several aspects of raw material strategy for advanced therapies as well as the need for trained technicians in the industry. With a bachelor of science degree in biology from Tulane University (New Orleans, LA, 1983) and a medical doctorate from the University of Pennsylvania (Philadelphia, PA, 1988), Scott Burger served his residency training and fellowship at Washington University…

Four Design Factors Shaping Multimodal Cell and Gene Manufacturing

Cell and gene therapy manufacturing is about to hit a breaking point. The tension lies between increasingly diverse research pipelines and a tradition of dedicated facilities built for single-product, large-scale manufacturing. That incompatibility is widening as more cell and gene therapy products progress toward commercial production, forcing manufacturers to make a choice: either invest in major facility modifications and complex technology transfers to keep up or break from tradition and explore the potential of multimodal manufacturing. More than half of…