Biochemicals/Raw Materials

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…

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…

Cell Banking in the Spotlight: Advising Biologics Developers About Cell Bank Preparation and Characterization

Living cells are at the heart of biotechnology, and cell lines for production and testing of biopharmaceuticals are highly valuable assets. The process of banking cells generally moves from development of a research cell bank (RCB) based on a clone of interest to establishment of a master cell bank (MCB), from which working cell banks (WCBs) can be produced. Especially for biotechnology startups, preparation of an MCB can involve a significant jump from work performed in standard laboratory conditions to…

Compounded Media Powder Streamlines Cell Culture Media Preparation Operations

Cell culture medium is critical to cell growth, metabolism, and protein expression. It provides for optimum pH, osmolality, and nutrients in an environment that is essential for cell survival, growth, and expression of proteins and/or metabolites and drug-substance modalities of interest (1). A complete medium typically contains basic nutrients such as carbohydrates, amino acids, lipids, salts, vitamins, trace metals, growth factors/hormones (e.g., insulin), antishear factors, and other chemicals that facilitate cell growth and protein expression and may stabilize recombinant protein…

Fetal Bovine Serum Source Countries: Comparing Regulatory Animal Health Infrastructures

The motto of the European Serum Products Association (ESPA) — “Serum Saves Lives” — reaffirms the essential role that animal serum plays in cell-culture–based research and applications to protect the health of both human and animal populations. Animal serum, especially fetal bovine serum (FBS), needs to be available in abundant supply and at affordable prices to medical and veterinary facilities all over the world. With one billion cattle globally, the supply of FBS should be plentiful, but not all countries…

Intensified Seed Train Strategy for Faster, Cost-Effective Scale-Up of Biologics Manufacturing

The high costs of and limits on global accessibility of biologics such as monoclonal antibodies (MAbs) are focusing the biopharmaceutical industry’s attention on strategies for rapid, economical development of such therapies. Process intensification is one approach to help shorten manufacturing timelines and reduce cost of goods (CoG) (1, 2). Today, process intensification in upstream cell culture enables biologics manufacturing in facilities with smaller footprints and lower scale-up volumes than was possible before. Intensified processing of Chinese hamster ovary (CHO) clones…

Cryopreserved Leukapheresis Materials Help Alleviate Donor Sourcing Issues

Reliable access to high-quality starting material is a primary challenge in cell therapy manufacturing. Freshly isolated leukopak starting materials depend on donor availability and are vulnerable to cell losses from scheduling changes and other unforeseen circumstances. Flexibility often is required for cell therapy manufacturing. Therefore, relying solely on freshly isolated starting material is impractical, particularly when cell therapy logistics involve global shipping and distribution. Donor sourcing is among the most critical factors shaping cell and gene therapy (CGT) supply chains.…

eBook: Raw Material Control Strategy — Leveraging Knowledge of Material Attributes and Data Analytics as Key Elements

Ensuring pharmaceutical quality begins with in-depth understanding of process/platform capabilities, which is informed by knowledge gained through product and process development, subject-matter expertise, and lessons learned from experience. And all outside factors that can affect manufacturing outcomes must be taken into consideration. Extra vigilance is necessary for understanding potential sources of variation and maintaining robust control strategies to ensure process consistency — and ultimately product quality for patients. Biomanufacturing unit operations require multiple raw materials that must be documented as…

Using Peptones to Achieve Diverse and Demanding Bioproduction Goals

As bioproduction requirements advance, it is critical to have consistent, high-quality media and supplements that continue to meet evolving industry needs. Peptones have been successfully used in bioproduction applications for more than 30 years to meet diverse and demanding production requirements. Their unique nutritional profiles and usage flexibility make peptones ideal components for creating a robust bioprocess. This Special Report will demonstrate the benefits of peptones and how they can be used to enhance process performance and consistently yield a…

Toward a Roadmap for Cell-Free Synthesis in Bioprocessing

Cell-free synthesis (CFS), also known as cell-free transcription and translation, supplements cellular components (either a cell lysate or purified recombinant elements) with nucleotides, amino acids, metabolic intermediates, and salts to produce a nucleic acid or protein from a genetic template added to the reaction. This exciting technology has seen a substantial increase in both academic and commercial interest over the past decade (1). Interest stems in large part from the potential to democratize access to the machinery of biology by…