Biologic Drugs

Last year, a monoclonal antibody, TGN1412, led to potentially fatal adverse effects in a small group of Phase I volunteers in London. In the wake of this incident, EMEA has drawn up new guidelines that could lead to demands for more data on novel biologics. They may have implications for both manufacturing and clinical trials of biopharmaceuticals that are considered to pose a high risk to patients.

The UK, with its high quality educational capabilities in bioscience, has an opportunity to become the global hub of bioscience training, but must act quickly to secure this position.

The combination of supercritical fluid chromatography with chiral separation media offers several analytival advantages over traditional liquid chromatography techniques.

The scale-up of manufacturing processes to clinical production can be complicated and expensive, with many issues to consider. This article describes some of the common and less obvious pitfalls encountered by biopharmaceutical companies when scaling up protein production processes, and how to avoid them.

Ultrahigh pressure liquid chromatography maximizes efficiency, but, as defined by the resolution equation, the stationary phase is still a crucial consideration when attempting to resolve mixtures of compounds.

High performance liquid chromatography has become an efficient technique at the production scale, and simulated moving bed chromatography provides several benefits during processing.

A new economical method for producing fast-melting lamina-like dosage forms.

In biomanufacturing, multiple sensors provide a wealth of data that could be used to enhance process understanding and assist in performance improvement. This article looks at how to move from a data-rich environment to one where the data are translated to useful information that leads to knowledge and, ultimately, process improvements.

Getting from a cell culture to a purified biotech product is a demanding exercise involving many operations. Increasing productivity in the upstream part of biotech production is placing new demands on the purification process, which may lead to adopting new technologies.

... the biotech industry could make characterization of its products easier by paying more attention to downstream processing and purification issues, creating a cleaner product that is easier to identify.

Pharma companies and CMOs build positions in mAbs.

Nanotechnology is emerging as a tool for resolving challenges in delivering poorly water soluble and highly potent drugs.

Exhibitors' products prevent counterfeiting, provide child resistance, protect product quality, and improve packaging-line efficiency.

Sterile liquids are frequently transferred during the processing of sterile liquid drugs such as injectables or ophthalmic drops. Several types of transfer can be performed, each requiring a validated method to ensure the desired sterility-assurance levels are achieved.

It has been a long time coming, but stakeholders in the US are now seriously debating a route to market for cheaper copies of biopharmaceutical drugs. The European Agency for the Evaluation of Medicinal Products (EMEA) has led the way on this issue by publishing clear guidelines on what companies must do to get their versions of drugs such as erythropoietin (EPO), an advanced treatment for anæmia, and similar products approved.

Cells function as highly accurate quality control (QC) machines to ensure that only correctly folded proteins are released into the physiological milieu to perform their designated functions. The efficient removal of damaged or incorrectly folded/misfolded proteins at the correct time keeps a cell viable and functioning.

This article discusses a number of factors that may influence the behaviour of conjugated biopharmaceuticals. Optimizing bioconjugation processes may be critical to achieve the desired drug performance.

...Scotland has a favourable regulatory environment, funding support from its government and some of the most advanced research facilities in the world.

... there is a huge manufacturing challenge involved in bringing cell therapies (especially stem cell therapies) from the lab bench into the clinic.

Washington, DC (Feb. 22)-The Biotechnology Industry Organization criticized two separate studies respectively released by the Pharmaceutical Care Management Association and Express Scripts, Inc. regarding the cost-savings, interchangeability, and market penetration of follow-on biologics.

Disposables simplify the flow of people and materials through a facility, decreasing both its footprint and amount of equipment needed, as well as minimizing upfront capital costs.

While single-use technologies can be used for filtration, storage and at connection points in egg-based vaccine production, their use multiplies in cell-based applications.

Washington, DC (Jan. 26)-The US Department of Health and Human Services has granted targeted liability protections for manufacturers of a vaccine to prevent a pandemic of influenza A (H5N1).

Over the past decade, disposable technologies have become a reality in biotech processes. The use of disposables in research and manufacturing allows high flexibility.

Brain and heart broth is still used in path labs, but, when it comes to biopharmaceutical manufacturing, cells are having to learn to do without animal components whenever possible.

The US Department of Health and Human Services (HHS, Washington, DC) has awarded three vaccine makers a total of $132.5 million to advance their strategies for adjuvant-containing vaccines to combat the H5N1 strain of avian influenza. Under the contracts, each company will build capacity to produce either 150 million does of the vaccine or enough adjuvant for 150 million doses within six months after the onset of an influenza pandemic.

The concept of quality should not only apply to the manufacture of the media - it should also continue throughout the product's lifetime of usage.

There are currently several hundred biotech-based drugs in clinical trials, representing around a quarter of all drugs in development - a proportion that looks set to increase.

Biotechnology stocks dropped 14% in 2006, giving up more than half of the value they'd picked up during a "stellar" 2005, according to G. Steven Burrill, CEO of Burrill & Company (www.burrillandco.com), the venture and merhant banking company. "Overall, it wasn't a great year for biotech," said Burrill in a year-end analysis, indicating that the biotechnology industry will finish the year with its collective market capitalization essentially unchanged, at approximately $490 billion. As for the future, biotechnology will continue to fuel a the transformation in healthcare, a tansformation emphasizing earlier disease detection, more targeted treatments, and adjunctive support through enhanced nutrition. We will see further progress on the personalized, predictive, preventative front...with new products targeting the "individualization" of medicine in the marketplace. Other predictions for 2007 include...