News

11 Universities Join FDA ?National Institute for Pharmaceutical Technology and Education?

New FDA Guidance on Electronic Common Technical Document Submissions

US District Court Rejects FDA Suit to Block Device Manufacturer

Novartis Purchases Chiron in a Total Buyout

Moheb Nasr, PhD, director of the newly created Office of New Drug Quality Assessment at the US Food and Drug Administration (Rockville, MD, www.fda.gov), has proposed creating a "regulatory agreement" between FDA and sponsors to govern the chemistry, manufacturing, and controls (CMC) sections of new drug applications (NDAs).

Making active pharmaceutical ingredients (APIs) requires long chains of chemical reactions and large quantities of solvents. Ask API manufacturers how they'd like to improve this process, and the responses are likely to be "make the reactions faster," "make the reactions cheaper," or "make the reactions more efficient." Then after all these economically driven answers, you might here, "make the reactions more environmentally friendly."

Information technology can streamline compliance and increase operational efficiency and quality.

A range of insect exterminator equipment has been developed to improve the level of hygiene offered to the pharmaceutical and chemical manufacturing sectors. Berson's Insectron range uses ultraviolet (UV-A) and green light to attract flying insects, which are sensitive to these light sources.

Sigma-Aldrich Fine Chemicals (SAFC) has set up a new business division called SAFC Biosciences to encompass its biopharmaceutical development and cell culture-related manufacturing services.

Lester Crawford, FDA's top man, has resigned explaining that it was time to step down — despite only being promoted to commissioner earlier this year.

FDA's Evans Reviews Causes of Warnings and Recalls

Roche Plans New US Manufacturing Facility for Tamiflu while Cipla Prepares to Market Generic

Patheon, CEPH Begin Corrective Action Program for Omnicef OP

New Legislation To Ensure Stable Flu Supply

USP Announces Monograph Revisions List and Postponed Publication of General Chapter <1226>

FDA Proposes New CMC ?Regulatory Agreement?

Design Exhibition, ?From Master?s Thesis to Medicine Cabinet?

Collaboration Targets Single-Shot Japanese Encephalitis Vaccine

CEPH International Replies to FDA Warning Letter

CDER Creates Office of New Drug Quality Assessment

Ajaz Hussain Leaving FDA for Sandoz

The US Food and Drug Administration (Rockville, MD, www.fda.gov) released a new draft guidance that may speed generic approvals. The guidance, ANDAs: Impurities in Drug Products, describes the degradation-product information that generic drug manufacturers should include in their abbreviated new drug applications (ANDAs). This clarification, FDA officials say, will help companies submit the correct information, thus increasing the likelihood that their generic drugs will be approved, and approved more quickly.

One of the world leaders in the manufacture of tablet compression tooling, I Holland, is offering a range of machines for the automatic polishing of tablet compression tooling.

Adding Braille to pharmaceutical packaging should be less of a challenge with the use of Esko-Graphics' Scope solution. EC Directive 2004/27/CE requires Braille labelling and information to be provided with pharmaceutical products for human use, and companies are scrambling to implement this by 31 October.

Biogen to Cut Jobs

The US National Institute of Allergy and Infectious Diseases (NIAID, Bethesda, MD, www3.niaid.nih.gov) announced it will order two million doses of an avian influenza vaccine from Sanofi-Pasteur (Swiftwater, PA and Lyon, France, www. sanofipasteur.com). In April, the NIAID began a Phase I trial to evaluate the vaccine’s safety and ability to generate immunity against the H5N1 strain of avian flu, an illness that leads to severe disease and possible death in birds and humans.

Manufacturers of pharmaceuticals and nutraceuticals can protect their products from moisture and other elements while also enhancing marketability, by adding scent to their packaging. The full line of scented packaging solutions, offered by Süd-chemie, is reported to be ideal for applications that emit an unappealing odour to end users. The packaging can also enhance the marketability of odourless products. The flagship product in the scented solution line is Aroma-Can — a product modelled after the company's desiccant canisters. One-gram canisters will be available in orange and lemon scented variations, and can be inserted at the same high rates of speed as traditional desiccant canisters using standard canister insertion equipment.

Two of the largest companies in the pharma industry are to join forces to supply and distribute 96-well Multi-SPE Extraction Plates. The instruments, which are to be circulated by Millipore, are manufactured by 3M for the purpose of isolating and concentrating low levels of analytes, and function by removing substances that interfere with mass spectrometry signal detection. The devices feature 3M Empore membranes, which produce clean extracts, extend LC-MS/MS column life and decrease instrument downtime.

Chiron Corporation (Emeryville, CA, www.chiron.com) announced that quality problems at its Marlburg, Germany, manufacturing plant will prevent the company from supplying its "Begrivac" influenza virus vaccine to non-US markets for the 2005–2006 flu season.

To help meet the needs of the fast-growing, global biopharmaceuticals industry, Pall Corporation has launched five innovative technologies aimed at increasing drug-manufacturing efficiency through customization and disposability. The Mustang XT5000 capsule is the company's novel chromatography technology for efficient capture of large molecules, especially used to develop DNA and virus-based drugs. Expanding its portfolio of technologies for disposable processing, Pall offers both the customizable Tangential Flow Filtration system, which incorporates single-use components for downstream processing applications, and the Kleenpak Connector — a new single-use device, which enables aseptic connections to be made instantly.