Happy autumn! I am writing this a few days before the editors head to Biotech Week Boston and the BPI conference. This is my first travel since January of 2020, and I am eager to see everyone again. As usual, the fall months coincide with our finalizing next year’s editorial calendar. I will be able to share those details (and other BPI news) with you in our next issue. One major project that came our way a few months ago…
In the first cell therapy special issue of BioProcess International back in 2011, members of the International Society for Cell and Gene Therapy’s (ISCT’s) commercialization committee highlighted the need for cell-processing professionals who prepare bone-marrow and cord-blood products to collaborate with bioprocess engineers in establishing commercially-relevant manufacturing processes for a new wave of cell-based therapies (1). The emerging field of cell and gene therapy presented unique challenges for creating scalable bioprocesses under current good manufacturing practices (CGMPs) to accommodate primary…
The past 20 years have been extraordinary for intellectual property law. Most of the transformations can be attributed to changes in the statute, US Supreme Court jurisprudence, almost complete turnover in judges in the Court of Appeals for the Federal Circuit (“Federal Circuit,” below), and advances in technology that could not have been anticipated in 2002. An understanding of those changes requires a retrospective of patent law over those 20 years. At that time, the Federal Circuit was 20 years…
Cleaning validation receives a great deal of attention within the biopharmaceutical industry, not least because of the risks of product adulteration and hence patient harm from improperly cleaned surfaces (notwithstanding additional concerns such as operator protection). Traditionally, cleaning validation efforts focus on direct product-contact surfaces. However, the hazard and resultant risk posed from indirect product-contact surfaces should not be underestimated. Consideration of the risks presented by indirect surfaces should figure into every contamination-control strategy. Understanding of these risks cannot be…
Sterilizing-grade filtration is an essential operation for biomanufacturing. It ensures that drug substances are free from microorganisms at the end of a downstream process. The COVID-19 pandemic has highlighted the need for high-quality therapies to be manufactured efficiently at scale, with particular focus on the need for multiple vaccines to be developed, produced, and distributed globally (1). Some vaccines have used lipid nanoparticle encapsulation technology, which also has potential for use in gene therapy development in the near future. Lipid…
Antibody–drug conjugates (ADCs) represent a growing therapeutic segment of the oncology field. Five such treatments received market approval from the US Food and Drug Administration (FDA) between 2008 and 2018, whereas three were approved in 2019 and two each were approved in 2020 and 2021 (1). This disruptive technology combines highly potent small-molecule payloads with monoclonal antibodies (MAbs) to improve their specificity as cancer treatment. The antibodies deliver those toxic compounds directly to cancer cells but not to healthy cells,…
Process-related impurities such as host cell proteins (HCPs) can raise concerns about biological product efficacy, quality, safety depending on their properties and levels. In the first part of this series, we surveyed relevant regulatory frameworks and detailed potential effects of HCPs on biologic efficacy. Here in part 2, we review available literature on HCPs and patient safety, including information about HCP-related immune responses and adverse clinical events. HCP Effects on Patient Safety At least five HCP-induced factors can influence a…
Microbiology has risen as a major part of global industry over the past three decades. Industrial microbiology, biotechnology, biopharma and now biointelligent production systems (1) embrace a wide range of manufacturing platforms and product areas involving microbes, animal cells, and plant cells — as well as whole organisms. The multibillion-dollar applications of biomanufacturing display great variety. They include microbial-based production of such valuable metabolites as amino acids, vitamins, solvents, and organic acids as well as larger products such as enzymes,…
Most biopharmaceuticals are manufactured in large-scale stainless-steel piping and vessels, with downstream processes taking place within rigid and inflexible facilities. Although process steps such as harvest, purification, fermentation, filtration, dispensing, and freezing require flexibility, stainless steel has not been replaced yet by single-use systems at a large scale. However, manufacturers wanting to optimize process efficiency and scalability to obtain a viable and valuable product for commercial use inevitably will need single-use technology. Aseptic fluid management with single-use systems offers numerous…
Proteins create cellular matrices, catalyze biochemical reactions, and form signaling pathways to respond to external stimuli. Studies of protein structure and function increase researchers’ understanding about the foundations of life. However, because most proteins are difficult to obtain commercially, it is important to establish sources that can provide researchers with plentiful supplies of proteins. In recombinant protein expression, a gene encoding a protein of interest is cloned into an expression vector (usually a plasmid) and transferred into a host cell…