There could be a serious glut of commercial scale mammalian cell culture capacity over the next five years. Then again, there could be a significant shortage. It all depends on how things develop in expression technology, the new product pipeline, and corporate strategies.
The evolution of therapeutic modalities drives the adoption of single-use technologies.
Despite a growing number of biosimilar approvals, market uptake remains a challenge.
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
When making critical decisions such as whether to build or buy critical capabilities, companies need a decision-making approach that weighs risks and rewards as a science with adequate inputs, repeatable processes, and measurable results. The method must also accommodate the human factor by encouraging wide participation and providing the kind of neutral decision criteria that satisfies participants about the objectivity of the process.
NeisVac-C is a polysaccharide-protein conjugate vaccine for use against Neisseria meningitidis serogroup C infection. The Phase 1 clinical formulation consisted of physiological saline, thimerosal, and aluminum hydroxide. The long-term stability data for both the PBS and saline formulations are presented in this article.
Interview with Roger Lias, president and group commercial director at Eden Biodesign, Inc.
This article discusses the production process of the major influenza antigen, hemagglutinin (HA), by rDNA methods in E. coli.
Interview with Magda Marquet, co-CEO and co-president of Althea Technologies
There are a number of specific characteristics to be considered when developing and manufacturing live bacterial vaccines.
The Center for Molecular Immunology (Havana, Cuba) has been working on a novel cancer immunotherapy targeting the epidermal growth factor (EGF). The vaccine is composed of a chemical conjugate of EGF and a carrier protein (rP64k), designed to trigger an anti-EGF antibody response. The results of studies of molecular characterization, immunogenic activity, and clinical data are presented here.
To succeed in a pandemic, the industry must forge a preparedness plan to ensure adequate vaccines.
The year 2007 witnessed the approval of fifteen biopharmaceuticals in the United States and European Union.
An analysis of current and upcoming industry challenges.
To achieve the right balance between disposable and reuseable options, companies must consider important technical and economic factors.
Manufacturers of biopharmaceuticals can improve productivity by taking patient wellness into account.
In addition to making technical developments, vendors are also looking at ways to improve supply-chain security. By offering standard, off-the-shelf products, vendors are able to shorten lead times and improve the security of supply.
As the use of disposable bioprocessing equipment has increased, a new question is gaining prominence: What is the best way to dispose of the equipment after use?
SciLog, Inc. (Middleton, WI), a privately held company that designs and manufactures computer-controlled bioprocessing equipment, has announced the signing of a patent licensing agreement with GE Healthcare (Somerset, NJ).
A discussion of past achievements and future expectations of recombinant protein production yields from mammalian cells.
With a variety of recombinant, animal-free, defined protein supplements such as growth factors, transferrin, and albumin entering the market, the biopharmaceutical industry now has innovative and safer alternatives to serum and other animal-derived supplements.
Recombinant protein and plasmid DNA production using microbial expression systems is the cornerstone of many biologics manufacturing processes. HCD methods are commonly used for these processes because of the advantages they provide.
Process-modeling tools can ensure smooth tech transfer.
The current focus on cost-of-goods (COGS) models is underplaying the benefits of disposables technology in biopharmaceutical manufacturing. The best method for accounting for the benefits of reduced and delayed capital expenditures is through the use of NPV analysis.
It is important to understand critical aspects of the CMO's capabilities. Only by auditing certain key areas can the sponsor be assured of the quality of the materials produced.
The industry needs to open up to validation failures.
US Food and Drug Administration's Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.
DSM Biologics (Heerlen, the Netherlands), and Upfront Chromatography A/S (Copenhagen, Denmark) have announced a collaboration to optimize Upfront’s new, fully disposable chromatography system for use with DSM's proprietary manufacturing technology.
The FDA is under attack from all sides. Many influential members of Congress either don't trust the agency to monitor the industry appropriately, or have found it politically expedient to keep sounding alarms about inadequate oversight of food and drug safety and clinical research. The good news is that there seems to be a growing consensus that FDA needs a major infusion of cash to regain its stature as an effective science-based regulatory agency.
