The following letter came in response to recent articles on lot-release testing and host-cell proteins: Schwertner D, Kirchner M. Are Generic HCP Assays Outdated? BioProcess Int. 8(5) 2010: 56–62. Rieder N, et al. The Roles of Bioactivity Assays in Lot Release and Stability Testing. BioProcess Int. 8(6) 2010:33–42. Members of our peer-review board recommended publishing this longer than average communication. A Rational Approach to Process-Specific Host-Cell Protein Detection So-called generic host-cell protein (HCP) antibodies and assay kits have proven to…
December 2010
Review, Approval, and Marketing of Biosimilars in the United States
During the past 30 years, advances in medicine and pharmaceutical research generated a new class of drugs called biologics. These drugs are complex proteins, carbohydrates, or other large molecules derived from biological sources (1). By contrast with more traditional pharmaceuticals (small-molecule drugs), biologics are not synthesized chemically from less complex components, but rather are derived from or manufactured using living organisms or extracted tissue (2) Biologics make up a small but significant percentage of the overall pharmaceutical market.…
The Human Factor in Facility Design Innovation
Bioprocess and pharmaceutical production environments must be well designed to meet strict cleanroom and quality assurance (QA) standards and productivity requirements. Managers may also consider innovative ways to enhance the design of these environments to enable the people critical to their companies’ success to be more productive and effective. In today’s work culture, countless hours can be lost to poor teamwork and ineffective communication. CGMP environments present additional, unique challenges to human interaction because of their built-in process and protocol…
The Dinosaurs Reborn: Evaluating Stainless Steel and Disposables in Large-Scale Biomanufacturing
Although a number of biomanufacturers have adopted disposable technologies for small-scale process design, there has been considerable debate over the role of single-use systems in large-scale biopharmaceutical manufacturing— particularly in retrofitting facilities. Some experts have gone so far as to suggest that large-scale stainless steel fermentors are “dinosaurs,†with their large capacities, long installation lead times, and low flexibility. I advocate a systematic approach to look holistically at possible retrofit technologies in existing (stainless steel) facilities, with particular…
Single-Use Systems As Principal Components in Bioproduction
Single-use systems (SUS) have become an accepted component of animal-cell–based bioproduction. No longer a merely exciting possibility, they have emerged as a significant and growing resource for companies to use from process development to manufacturing of approved products. Having been examined for years in less regulated environments, off-the-shelf SUS are now in regular use to some extent in nearly every segment of the production train by contract manufacturing organizations (CMOs) and biopharmaceutical companies in mid-scale production applications. For…
Scale-Up of a Plasmid DNA Purification Process
RecipharmCobra Biologics, Keele (previously Cobra Biomanufacturing Plc) has been producing plasmid DNA for clinical trials for more than 10 years and has an approved site under the EU clinical trials directive. During this period, the company has produced more than 40 plasmids (ranging from 500 mg to 5 g) for 25 customers in Europe and the United States. These plasmids have been used for gene therapy and vaccines as well as to produce viral vectors. RecipharmCobra has developed…
Linear Scale-Up of Cell Cultures
Reusable bioreactors have been the benchmark standard for many decades, during which a large knowledge base on process control and scale-up has been developed. However, single-use bioreactors are increasingly being implemented in modern bioindustrial upstream processes. Many of these bioreactors deviate from the traditional stirred-tank design, but a number of companies have expressed a strong need for single-use bioreactors based on the strirred-tank design. A traditional stirred-tank design would enable users to optimize their scale-up processes based on…
Risk Mitigation Through Improved Process Predictability
Unexpected events — whether catastrophic like the oil leak in the Gulf of Mexico or a disruptive supply chain shortage — can change the future of a company. To prevent such difficulties or at least minimize their impact, life sciences companies spend millions of dollars on daily analysis of enterprise-wide risks. Whereas supply chain and logistics are traditionally a focus of risk analysis teams, manufacturing and quality teams are now charged with improving process predictability. Through process understanding, that not…
Global Marketplace
Packaging Service: Flexible options in final assembly and secondary packaging Applications: Drugs and biologics Features: An international specialist in aseptic fill–finish, Vetter offers a range of options for final assembly and packaging of pharmaceutical and biotech products. The company provides semi- and fully automated secondary packaging; labeling, blistering, cartoning with package inserts, and case packing; assembly of pens, autoinjectors, and other safety devices; and high standards of cosmetic integrity. Contact Vetter Pharma International GmbH www.vetter-pharma.com Microbioreactors Product: ambr workstation Applications:…
IBC Life Sciences US 2011 Calendar
IBC Life Sciences has been supporting and supplying the life science industry with specialized information through conferences and courses since 1987. IBC Life Sciences events offer attendees the opportunity to gain new insights and hear latest developments as well as provide a forum to meet, connect, and network. New Directions for Diabetes Therapeutics (16–17 February 2011): Hilton Boston Back Bay, Boston, MA Viral Safety for Biologicals (24–25 February 2011): Walt Disney World Swan Resort, Lake Buena Vista, FL AsiaTIDES (2–4…