Manufacturing

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.

To date, calorimetry has not been given a fair trial in the PAT arena. Recent advances in reactor technology and design will ensure that real-time calorimetry is the present and future of PAT.

Recent regulatory initiatives have emphasized the need to improve pharmaceutical manufacturing. PAT marked the beginning of a number of regulatory efforts to encourage innovation and a transition towards science-based manufacturing. This article reviews the progress of the regulatory initiatives and describes two significant research initiatives to develop a future pharmaceutical manufacturing environment based on scientific understanding of pharmaceutical materials and processes.

Company and People Notes: Evotec and Renovis enter agreement, Amgen to lay off 675 workers, more.

The European Medicines Agency?s Committee for Medicinal Products for Human Use recommended the lifting of the suspension of the marketing authorization for ?Viracept? (nelfinavir mesylate) from Roche and the re-introduction of the drug in the European Union.

Reflecting a strategic interest to strengthen its position in biologics, Bristol-Myers Squibb agreed to acquire the biopharmaceutical company Adnexus Therapeutics for $430 million.

The US Food and Drug Administration has denied shipments of active pharmaceutical ingredients manufactured at a production facility of Kunshan Chemical and Pharmaceutical Co. for violation of good manufacturing practices, according to an FDA warning letter issued Sept. 6, 2007.

Company and People Notes: Catalent expands Bolton, UK, warehouse; Biotica appoints Edward E. Hodgkin as CEO and director; more.

Pfizer plans to cease all remaining manufacturing operations at its facility in Sandwich, Kent, United Kingdom. The closure will result in the loss of approximately 420 jobs, phased over the next two years, according to a company release

Bayer Schering Pharma officially completed the acquisition of Novartis?s biologics manufacturing facility in Emeryville, California.

The European Commission (EC) has deemed research-performing small- and medium-sized enterprises (SMEs) ?the entrepreneurial stars of Europe?, hoping to raise ?800 million extra funds for them.

Sartorius has officially started up operations at its new plant in Beijing. By building the new facility, the company has now doubled its production capacity in China from approximately 4000 m2 to more than 8000 m2; an additional building phase makes it possible to even quadruple the floor space in the future. The investment volume for the new plant site is about ?10 million.

Lundbeck and Takeda have formed a strategic alliance for the codevelopment and co-commercialization in the US and Japan of several compounds in Lundbeck's pipeline for mood and anxiety disorders.

Company and People Notes: Baxter and Halozyme Expand Relationship, Crucell Names COO, More.

More than 100 people attended this week’s Regulatory Affairs Conference by the International Pharmaceutical Excipients Council of the Americas to discuss the latest trends and challenges in the excipient supply chain.

The US Food and Drug Administration’s Interagency Working Group on Import Safety released a Strategic Framework based on a cost-effective, risk-based approach for ensuring the safety of products exported to the United States.

The United States House of Representatives passed its version of the Patent Reform Act of 2007 (H.R. 1908) in a 220–175 vote.

Aptuit expands its drug-development capabilities with the formation of Aptuit Laurus to take advantage of the growing pharmaceutical outsourcing market in India.

FDA must increase inspections of foreign API manufacturing facilities as more production moves offshore.

Contract manufacturers slim down to improve profitability.

Appendix: definitions and regulations, Federal Food, Drug, and Cosmetic Act; Appendix: definitions and regulations, Title 21 Code of Federal Regulations; Appendix: definitions and regulations, Compliance Policy Guides

News and Views

Going digital can produce high-quality, full-color labels at potentially lower cost.

User-fee legislation will require more testing and data disclosure to prevent unsafe drug use.

The influence of magnesium stearate (MgSt) on powder lubrication and finished solid-dose properties presents big challenges to drug manufacturers.

Jason Kamm, managing consultant with Tunnell Consulting discusses the challenges and opportunities for pharmaceutical manufacturers in ICH Q10, the draft guidance on pharmaceutical quality systems issued by the International Conference on Harmonization.