March 2012

Measuring kLa for Better Bioreactor Performance

Knowledge of kLa (the volumetric mass-transfer coefficient that describes the efficiency with which oxygen can be delivered to a bioreactor for a given set of operating conditions) is not new. Here I provide information for those who are unfamiliar with the measurement method and/or issues that must be considered when making these measurements. Advances in this area now make it advisable to run kLa measurements routinely in many bioprocesses. The Importance of Measuring kLa Before examining the process theory and…

Global Marketplace

Biobanking Resource Product: CryoFeed microsite Applications: Cell and tissue banking Features: Wheaton offers a curated collection of information about preserving cryogenic biospecimens online. The company responded to an influx of questions about sample containment by creating the CryoFeed website. It provides biobanking-related news and technical tips as well as a place where users can discuss related issues. As samples are collected and cryogenically stored at hospitals, universities, research institutions, and pharmaceutical companies, Wheaton says interest in biobanking and long-term storage…

IBC’s 22nd International Intensive Symposium Biological Assay Development, Validation, and Maintenance

Plan now to attend this highly technical conference for just the right mixture of practical tools, regulatory trend overviews, emerging technologies, and product case studies. Bioassay scientists are intensifying their use of new technologies. Quality by design validations are becoming common, with statistical tools implemented during development, and cells are being developed for single-use applications. This is the must-attend event for bioassay professionals who want to keep up with these changes — where scientists gather to discuss how to overcome…

From The Editor

Only recently did I finally get to watch the film Contagion, which was released this past fall. Sometimes the most provocative tests of our imagination come from our extreme fictional interpretations, and I was hopeful. (But remember Outbreak, the disappointing (if earnest) movie from the 1980s?) And I do believe this is a film worth recommending — both within and outside the industry. Mostly taking place in biosafety-level laboratories, Contagion does show how hard it is to isolate and grow…

Ten Years of Manufacturing

Our “manufacturing” theme could be considered a sort of catch-all, encompassing much of what BioProcess International covers. You could argue that “the whole development process” is all about manufacturing biotherapeutics. But we instead consider this “pillar” of bioprocessing to include everything that isn’t strictly “upstream” (production) or “downstream” (processing) of biomolecules. Facility and supply-chain isssues come into play here, as do formulation and fill–finish (and of course, outsourcing). We discuss quality systems and their associated analytics in this context, as…

Current Issues in Assuring Virological Safety of Biopharmaceuticals

The weakest link in the chain is also the strongest. It can break the chain.— Stanislaw Jerzy Lec, Polish writer, poet and satirist (1906–1966) Biologicals ushered in a new era for treating debilitating and life-threatening illnesses. According to a Pharmaceutical Research and Manufacturers of America (PhRMA) 2011 report, more than 900 biotech medicines and vaccines are in development that are targeting more than 100 diseases (1). Market researchers expect annual sales of biologics (now at about US$100 billion) to grow…

Biopharmaceutical and Medical Device Compliance

Almost every aspect of the biopharmaceutical and medical device industries raises regulatory compliance concerns. Heightened scrutiny is required across product lifecycles — from clinical trials to manufacturing, pricing, formulary placement, and promotional practices. Those areas (as well as patient privacy and adverse event reporting) require close attention to and compliance with healthcare laws, regulations, and guidelines. Part 1 of this two-part article describes statutes, regulations, and guidances applicable to the biopharmaceutical and medical device industries. Anti-Kickback and False Claim Laws…

What’s in a Game?

Not long ago, I was playing the popular board game Snakes and Ladders (also known as Chutes and Ladders) with my son. Based on an ancient Indian board game, it has over the years become a worldwide classic. The game is rather simple to play: Two or more players place their tokens on a game board that has numbered, gridded squares. They take turns rolling a single die to move their tokens by the number indicated by the die, following…

An Industry Perspective on Quality By Design

The US FDA’s quality by design (QbD) initiative and associated ICH Q8, Q9, and Q10 guidance documents are increasingly embraced by the biopharmaceutical manufacturing industry for ensuring consistent product quality and lower costs of development and manufacturing. One critical problem the industry faces involves understanding how to implement QbD and determine the benefit of such projects — which require the work of many groups across quality, manufacturing sciences, and engineering departments. Here we present the results from a survey of…

Revisiting Protein A Chromatography

Due to the molecular complexity of monoclonal antibodies (MAbs) and potential impurities in cell culture media before purification (host-cell proteins, DNA, media components) (1), subsequent downstream operations must consistently and reproducibly purify products to ensure safety and efficacy. The latest member of GE Healthcare’s MabSelect family is called MabSelect SuRe LX (2). As Table 1 shows, it has been developed using the same highly cross-linked agarose base matrix and protein A ligand as for other MAb affinity resins (Table 1).…