In this anniversary year, I find myself thinking back on things I once was told would never happen in — or never apply to — biopharmaceutical manufacturing. Initially peripheral (seemingly) topics ease into relevance and, by surprising us, emphasize the importance of keeping our eyes on the big picture(s). When I was an editorial assistant in the late 1980s, I was told simply to toss press releases related to, for example, anything having to do with centrifuges…
May 2012
Expansion of the Prior-User Rights Defense
A common reaction to some patents directed to manufacturing processes (especially of biotherapeutics) is “How did they get a patent for that when we’ve been doing the same thing for years?” But the number of patents covering biotherapeutic production processes is steadily increasing along with the realization that upstream and downstream processing events provide a potentially abundant source of so-called “second-generation” patent protection for biologics, especially those facing biosimilar competition. Although some groups are prolific patent filers claiming a wide…
Fight Cancer with Nanotechnology
Imagine a diagnostic test that sifts through millions of molecules in one drop of a patient’s blood to detect the tell-tale protein signature of a cancer subtype. Envision a drug “ferry†that doesn’t release its cytotoxic contents until it slips inside cancer cells — or a molecule or small panel of proteins that can reveal within days whether a cancer treatment is working. Bioprocess Applications of Nanoparticles () Researchers have created nanosized particles and devices that are…
Approaches to Debottlenecking and Process Optimization
Two major challenges associated with optimizing biomanufacturing operations remain unresolved. The first is variability: how to understand and improve manufacturing with significant variation in process times throughout all unit operations. The second is complexity: modern biomanufacturing facilities are complex and interconnected, with piping segments, transfer panels, and valve arrays, as well as water for injection (WFI) and other shared resource constraints. That complexity is becoming even greater with the need for process standardization and processing of higher (and…
Large-Scale, Single-Use Depth Filtration Systems
Clarifying cell culture broth is the first downstream unit operation in an elaborate sequence of steps required to purify a biological therapeutic. A combination of centrifugation, depth filtration, or tangential-flow filtration (TFF) is used for that operation. The availability of largescale, single-use, depth filtration technology in the recent years, however, has given process developers the capability to improve and simplify downstream processes. Clarification of Cell Culture Streams The main purpose of clarification is to efficiently separate…
Integrity Testing of Sterilizing-Grade Filters
Integrity testing of sterilizing-grade filters is necessary to reliably prevent damage to these sterile barriers from compromising the production of biopharmaceuticals. Documented integrity test results are essential to a manufacturing audit trail for releasing pharmaceutical products (1, 2). Accordingly, problems encountered during this testing can lead to considerable financial damages and substantial delays or even entirely prevent a production lot from being released to the market. Therefore, filter integrity testing is a critical step with high economic importance…
Retention of Highly Penetrative A. laidlawii Mycoplasma Cells
Mycoplasma are infamous for contaminating cell culture lines at rates as high as 80% (1,2,3,4,5). For biopharmaceutical processes, the inadvertent use of contaminated culture medium or medium components can lead to contamination of an aseptic process-validation media fill or cell culture medium for a bioreactor (6,7,8,9,10,11). Thoroughly testing medium components before use is generally impractical because of the large volume of material in use. Frequently, culture media cannot be autoclaved (because of the presence of heat-sensitive components or…
Global Marketplace
Affinity Chromatography Product: CaptureSelect affinity ligands Applications: Antibody-based separations Features: BAC BV has teamed up with both Life Technologies and GE Healthcare to supply them with CaptureSelect antibodies for use as chromatography ligands. Life Technologies has launched a 0.1- to 7.9-mL range of POROS columns for analytical chromatography for IgG, IgM, human serum albumin fusion proteins, and antibody fragments containing κ or λ light chains. GE Healthcare has added LambdaFabSelect for GMP purification of antibodies and fragments that contain λ…
IBC’s 9th Annual Single-Use Applications for Biopharmaceutical Manufacturing
This conference offers solutions toward better industry cooperation in standards harmonization and downstream processing. New applications for disposables in fill–finish and bulk storage will be covered through a series of case studies, panel discussions, point–counterpoint debates, and breakout-discussion roundtables. Program Highlights PDA Task Force for Single-Use Systems will outline a technical report overview and concepts focused on extractables and leachables. Genentech will disclose additional data from experiences with disposable bags for cell culture media storage. A panel of experts from…
Biobanking Basics
With increasing large-scale “-omic†and clinical studies, the value and need for large and small biobanks or biorepositories has grown exponentially. Many organizations are processing and storing hundreds, thousands, even millions of biosamples. Those samples are collected from a number of sources, however, and put to end uses that are not always anticipated at collection. Consistent standards thus must be established to collect and store samples. Everyone involved must work toward a common goal of high-quality, consistent, reliable,…