Laura Bush

It seems clear that insuring the roughly 46 million Americans who are now uninsured will increase drug sales.

The US Food and Drug Administration announced yesterday that it has approved four vaccines against the 2009(A)H1N1 (?swine?) influenza virus.

Lonza (Basel, Switzerland), broke ground earlier this week on a new cell therapy manufacturing facility in Tuas Biomedical Park, Singapore, adjacent to Lonza?s large-scale mammalian manufacturing facility.

Novavax (Rockville, MD) recently achieved positive Phase 2a results for its trivalent virus-like particle (VLP) vaccine against seasonal influenza, and positive preclinical results for a VLP vaccine against H1NI (swine) flu.

If risk assessments only identify "the usual suspects," the process will not add much value.

ICH Q9 encourages companies to apply the concept of quality risk management. Easier said than done.

Protalix BioTherapeutics received approval from the US FDA on August 17 to proceed with its treatment protocol for prGCD, a development drug for Gaucher's disease.

SAFC Biosciences (St. Louis, MO) has developed a chemically defined cell culture supplement based on the characterization of hydrolysate components proven to provide cell growth and protein production capabilities equivalent to traditional undefined hydrolysate raw materials.

The prospect of conducting risk assessments, as part of the quality risk management strategy promoted by the International Conference on Harmonization (ICH) Q9 guideline, tends to evoke blank stares and confusion. It also prompts many questions: Which of the many tools-PHA, HACCP, FMEA, etc.-should we use?

Sartorius Stedim Biotech (Goettingen, Germany) and SAFC Biosciences (St. Louis, MO), a division of SAFC, have entered into a partnership to share expertise, support each other in developing custom solutions for customers, and generate data on the performance of equipment in different applications.

Perhaps the best way to regulate drugs is to regulate them not conservatively or liberally, but effectively.

The truth is, we should have been afraid of H1N1, because the threat of a flu pandemic is real.

Genzyme Corporation has halted production at its manufacturing plant in Allston Landing, MA, because it has detected a virus that impairs cell growth in one of the six bioreactors there.

Importing foreign drugs is not the best way to increase access to medicine. The risks are too high, and it burdens the over-stretched FDA unfairly.

Members of the pharmaceutical and biotech industries have formed a new industry coalition, called "Rx-360," with the goal of improving supply chain safety.

The current outbreak of the H1N1 influenza strain is exactly the kind of situation the vaccine company Novavax (Rockville, MD) has been preparing for over the last three years.

Avoiding healthcare reform is not the best option for the pharmaceutical industry.

A new excipient monograph standard for recombinant human albumin (HSA) became official in the United States Pharmacopeia-National Formulary (USP-NF) today, and Novozymes Biopharma (Nottingham, UK) says that its "Recombumin" and "Albucult" products are the first to comply with the new standard.

In response to requests from the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration yesterday authorized the use of the antiviral drugs Tamiflu and Relenza beyond their approved indications in response to the outbreak of swine flu.

Centocor Ortho Biotech (Horsham, PA), a subsidiary of Johnson & Johnson, received approval from the US Food and Drug Administration on April 24 for Simponi (golimumbad), a monthly treatment for moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

When the final version of the Quality by Design (QbD) case study is made public this summer, it will be an aspirational document, says Ken Seamon, PhD, one of the project?s facilitators. "If the regulatory authorities read our final document and said 'yes, this is all fine,' we will have failed," he said.

The 45 comments submitted raised concerns about legacy products and ongoing process monitoring.

In the Food and Drug Administration?s draft revision of the 1987 Process Validation Guidance, the lack of clarity about how the revised guideline applies to legacy products and the potential burden of new requirements for ongoing process monitoring are common concerns raised in many of the comments submitted by industry to the agency. To date, more than 45 companies or organizations have submitted comments on the draft revision, issued in November 2008.

At some point, will heavy investments in large, stainless-steel based facilities become a burden to US companies?

Even the best biotech companies lack a crystal ball. In 2003, Genentech had a shortage of manufacturing capacity. So they started an internal campaign, called "Every Gram Counts," to produce as much as possible.

How change plays out will depend not only on the new Whitehouse, but on pharma leaders' ability to adapt to changing times.

Looking ahead at the biopharmaceutical industry into 2009.

The US Food and Drug Administration has issued a new draft guidance document on process validation. This much-awaited revision of the 1987 guidance of the same name has been in the works for at least three years, and is being welcomed by industry experts.

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

Despite creating plastic waste, the disposables option is better for the environment.