Development

The FDA's revised process validation guidance manages to explain the underlying concepts of Quality by Design without every using the phrase.

Using multivariate experiments to define acceptable ranges.

The FDA and other regulatory authorities are evaluating new regulations to ensure the safety and quality of nanomaterials in biomedical products.

Well-designed experiments can reduce the risk of coming to an incorrect conclusion during a process characterization, assay validation, or process validation study.

The year 2007 witnessed the approval of fifteen biopharmaceuticals in the United States and European Union.

The FDA's QbD pilot program is supporting good manufacturing on a global basis.

In biomanufacturing today, there is increasing focus on improving process development. The goal is to accelerate development and reduce costs, without compromising the ability to scale up to a robust commercial process later on.

Every biotech company reaches a point in its development where it must decide what path it will take after it passes the start-up phase. This article discusses what the company must consider to decide what business model it will follow.

How to implement a risk-based approach to eliminating viruses.

The heparin debacle and other crises involving imported drugs and biologics has put pressure on the US FDA to step up its oversight of foreign drug manufacturing.

Set limits to provide incentives for process improvements.

A review of some recent contributions in process chromatography.

The Sentinel System aims to generate more adverse event reporting by health professionals, to analyze health information more effectively, and to enhance FDA methods for communicating new safety information to providers and patients.

Quality by Design and Design Space can be used by companies to enhance process understanding, improve scientific rigor, and enhanced qualitative and quantative performance, as well as cost savings.

The US Food and Drugs Administration is boosting its efforts for orphan drugs development.

Resolve confusion about measurements.

Best methods to maximize product yield and membrane lifetime to enhance a tangential flow filtration process.

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.

Gene fusion tags can improve the yield and solubility of many recombinant proteins. This article discusses the most popular fusion tags and the proteases used to remove them, with special reference to recently introduced technologies.

Using chemically defined feeds with CHO cell lines not only eliminates the variability associated with using plant hydrolysates, but could also improve the productivity of biopharmaceutical protein manufacture and help move therapeutic proteins into clinical trials more rapidly.

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 comparative research approach may be preferable to price controls in the guise of government negotiations for the Medicare drug benefit, coverage denials, and limits on access to new technologies.

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.

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.

The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues. QbD scientifically provides a greater understanding of the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy by determining the various permutations of critical input variables that will keep the product within specification.

A comparison of primary harvest techniques.

Disposable technologies that mimic the conventional stainless-steel bioreactor will be most readily adopted

The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight.