The pandemic forced many companies in many industries around the world to rethink how to get work done with much less in-person interaction than ever before. For the few of us who already worked from home at least part time, it wasn’t quite business as usual — but only because the circumstances brought technological and procedural improvements in how we work remotely. For most of our colleagues, however, it was a bit like getting tossed into the deep end of…
I was both excited and curious the day I started a new job in the quality affairs department of a pharmaceutical company. As usual, I attended onboarding meetings and received a training plan that contained a list of standard operating procedures (SOPs). So far, so good. But once I looked into the company’s training documents, my excitement turned to surprise. The SOP training included more than 150 good practice (GxP) SOPs, several of them longer than 50 pages and full…
The SARS-CoV-2 pandemic created unprecedented stresses on bioprocessing and healthcare supply chains as suppliers struggled to find materials to meet demand for COVID-19 vaccines and therapeutics. BioPlan Associates, with BioPhorum and its members, recently researched the biomanufacturing industry’s response to the pandemic and prepared a white paper, Impact of COVID-19 on the Bioprocessing Supply Chain (1). Before COVID-19, the bioprocess supply industry had been growing consistently at 12–14% (nearly doubling revenue every five years) since 1990. During COVID, growth in…
Particulates are mobile, undissolved particles other than gas bubbles that are unintentionally present in an injectable drug product. Patient safety can be compromised by the amounts and types of particulates present in a drug product (1). They differ in nature (e.g., metal, glass, dust, fiber, rubber, polymer, mold, and degradant precipitates) and can be divided into three categories: intrinsic, inherent, and extrinsic particulates. Intrinsic (native) particles are derived from operation of a manufacturing process or its equipment, a product formulation,…
Biologics manufacturing entails multiple complex unit operations across three key process areas: cell culture, purification, and sterile fill–finish (Figure 1). Numerous raw materials are used to formulate reagents that are vital to those processes. For example, bioreactors require cell-culture media, and buffer solutions are used during both drug-substance filtration and drug-product final formulation. Changes in raw-material properties can introduce variation in the performance of intermediate processes and in product quality attributes. Therefore, raw-material properties must be monitored to help ensure…
Before June 2015, pharmaceutical manufacturing of certain types of drugs required dedicated facilities. The European good manufacturing practice (GMP) guidelines state that to minimize the risk of cross-contamination, “dedicated and self-contained facilities must be available for the production of particular medicinal products, such as highly sensitizing materials (e.g., penicillin) or biological preparations (e.g., from live microorganisms). The production of certain additional products, such as certain antibiotics, certain hormones, certain cytotoxics, certain highly active drugs, and nonmedicinal products should not be…
Critical quality attributes (CQAs) such as safety, efficacy, purity, and identity must be monitored and controlled in biopharmaceutical products to meet predefined specification limits. Setting such parameters is critical but challenging. Unduly narrow specification limits increase risks for rejecting good product batches, whereas overbroad limits can lead to acceptance of bad batches (1). Limited sample sizes, homogeneous results obtained from testing of raw materials exhibiting scant variability, and variability inherent to testing methodologies can add up, encouraging quality teams to…
Minimizing a facility footprint while maximizing manufacturing capacity is essential to staying agile, productive, and cost-effective — all of which are key elements to competing in a dynamic business landscape. To achieve such efficiency at commercial scale, bioprocessing facility design should be tailored to each organization’s specific needs. During scale-up, tailor-designed facility planning is critical to streamlined manufacturing of high-quality products. The size and layout of a space can otherwise become a limiting factor for long-term productivity, revenue, profit, and…
Early evidence of budding C-type particles from Chinese hamster ovary (CHO) cells was documented in the 1970s and 1980s (1, 2). In the early 1990s, scientists from Genentech began to characterize these “retrovirus-like particles” (RVLPs) from CHO cells (3). Although proven to be noninfectious (1, 2), the endogenous particles caused regulators to require a demonstration of retrovirus clearance before clinical trials or market approval authorization (4). To accomplish that, the biopharmaceutical industry adopted the use of xenotropic murine leukemia virus…
Valuable bulk biopharmaceutical intermediates, such as bacterial or yeast cells for microbial fermentation or materials produced during a biomanufacturing process, often are transported to and from different manufacturing sites. During that transfer, maintaining product quality while minimizing degradation in desired properties is of utmost importance. It requires carefully controlled and reliable cold-chain logistics, which in turn rely on the equally carefully controlled process steps of freezing and thawing. Spray drying is a widely used method for preserving microbial cells. However,…