Barring fire, major earthquakes, or volcanic catastrophe, concrete is good for centuries — the Pantheon has been in continuous use since 126 AD. The long expected life and high initial cost of biomanufacturing buildings and equipment builds legacy into the system from the start. And the imperatives of launching a new biotechnology industry in the 1980s led to the building of many facilities within a few years to produce the first wave of recombinant DNA products. I spoke…
November 2012
Participating in the Rx-360 Pilot Joint Audit Program
The Rx-360 consortium has had a profoundly positive impact on pharmaceutical manufacturers and their suppliers. As an international, nonprofit, pharmaceutical supply chain group (established in 2009), its mission is to “create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by enhancing product quality and authenticity throughout the supply chain†(1). The list of consortium members (www.rx-360.org/Membership/ListofMembers/tabid/71/Default.aspx) is diverse and presently includes both pharmaceutical manufacturers and suppliers (24 and…
The Global Cold Chain
In biopharmaceutical development, ancillary business operations such as logistics and supply chain management are frequently perceived as secondary objectives to the ultimate goal of discovering treatments and cures for devastating diseases. However, in the hypercompetitive world of drug development, forward-thinking companies have found that optimizing their clinical-trial supply chain can provide a strategic advantage to accelerating drug development. The globalization of clinical research has made the safe, punctual, and compliant transport of study drugs and other temperature-sensitive materials increasingly complex.…
Toward Nonantibody Platforms
Monoclonal antibodies (MAbs) remain the largest segment of the biopharmaceutical market, but they are not the only recombinant proteins in development. Remember that the first biopharmaceutical approved for sale was recombinant insulin — a hormone — back in the 1980s. And proteins aren’t the only recombinant biologics. The sector has expanded since then to include gene therapies and viral vectors, vaccines, and even cells and tissues. Companies around the world are developing such products for cancer, neurological, infectious disease, metabolic,…
Polysorbates, Immunogenicity, and the Totality of the Evidence
Protein aggregation underlies many deleterious effects for biotherapeutics. Principal among those are loss of efficacy, induction of unwanted immunogenicity, altered pharmacokinetics, and reduced shelf life. Consequently, aggregation-preventing surfactants are essential components of many protein formulations. They facilitate the development, manufacture, and stability of dosage forms by helping formulators manage protein aggregation and reduce interactions with container and delivery device surfaces. Monoclonal antibodies (MAbs) present difficulties with respect to aggregation because they usually require relatively high doses for therapeutic…
Carrier Protein Outsourcing
Vaccines represent a significant, increasing area of product development within the biopharmaceutical industry. The segment includes several blockbuster commercial products, nearly 300 vaccines currently in development, and many more candidates in various stages of research and preclinical development (1). The 2010 worldwide vaccine market was ~US$20 billion and is projected to approach $30 billion by 2015 (2). Conjugate vaccines sales currently exceed $7 billion and are expected to increase substantially. Conjugate vaccines (covalently linked polysaccharide and protein) have…
Attaining Next-Level Titers in CHO Fed-Batch Cultures
Taking full advantage of high cell-specific productivity of recombinant proteins requires use of robust fed-batch processes involving addition of one or more concentrated nutrient solutions. Proportionately large amounts of concentrated nutrient supplements are often needed to support the stoichiometrically balanced metabolic requirements of high-density cell cultures. Large feed additions ultimately dilute the final product at harvest, but attempts to minimize feed volumes often lead to multiple concentrated acidic and basic subgroups. Those impart additional complexity to manufacturing processes.…
Global Marketplace
Single-Use Technology Product: inSITE inflation and integrity testing system Applications: Media/buffer preparation, filtration, separations, seed/culture harvest, ultrafiltration, final filling Features: ASI’s inSITE system applies a final integrity test at the point of use to eliminate concerns for gross and fine leaks that can come from handling and loading procedures. The unit will inflate to a specified pressure to limit errors from pinching and creasing. It can be used with any container ≤3,000 L and is completely mobile with cleanroom-grade wheels…
IBC’s Fifth Annual AsiaTIDES
This is the only event in Japan with coverage of all oligonucleotide classes: RNAi, peptide therapeutics, and vaccines. AsiaTIDES continues to be the premier forum where attendees get a comprehensive update, meet key players, and increase their knowledge of the oligonucleotide- and peptide-based therapeutics fields. Hear the latest reports from RXi, Tekmira, Santaris, miRagen, Arrowhead, REPLICor, Noxxon, Silence, PeptiDream, Pfizer, Immunovaccine, OncoTherapy Science, Zealand, Radius, Aileron, and more. Learn manufacturing capabilities of all the major oligonucleotide and peptide contract manufacturing…
A New Path in the Fight Against Melanoma
Increased activation of cell survival signaling cascades helps tumor cells grow and makes cancer cells difficult to kill. Inhibiting proteins involved in those survival pathways is a useful strategy for selectively destroying such cells. The mitogen-activated protein kinase (MAPK) pathway is one such signaling cascade. Preclinical research finds that it is activated in most melanomas. One key kinase involved has become the focus of some targeted melanoma therapies. MAPK/ERK kinase (MEK), also known as MAPKK, has several known…