Minakem Group has completed the acquisition of AstraZeneca's APIs plant in Dunkirk, France and has signed a long-term supply contract for Budesonide, Omeprazole and Esomeprazole.

Dunkirk's three sites can produce multiple API’s simultaneously, with one unit dedicated to the production of corticosteroids. This acquisition adds to Minakem's manufacturing capabilities, including injectable grades, and micronization services, and raises its custom synthesis capacity to about 450 m3 of batch reactors. These resources allow Minakem to provide process and synthesis development, clinical production, short campaigns for niche API’s as well as high volume API’s.

The three FDA-inspected factories at the plant include: Leuna for hazardous chemistry, large volume intermediate and short multi-step syntheses for medium scale API’s; Beuvry-la-Forêt for complex multi-step syntheses, short campaigns and niche API’s; Dunkirk for high-volume API’s, solid treatments and corticosteroids.

Minakem will have a unified commercial and marketing team and will implement a key account management policy for its major custom-synthesis clients. Chemtec Leuna GmbH will be renamed Minakem Leuna GmbH and remains managed by Karsten Fischer. Minakem SAS will be renamed Minakem Dunkerque SAS and Alexandre Gruman will serve as managing director.

Regulus Therapeutics, Inc. achieved the initial milestone in its worldwide strategic alliance with GlaxoSmithKline to discover, develop and market novel microRNA-based therapeutics to treat inflammatory diseases. The two companies are working to identify drugs directed at four different microRNA targets related to inflammatory disease. Regulus received an undisclosed payment for the first demonstration of pharmacological effect in immune cells by specific microRNA inhibition.

“This milestone is further evidence that microRNAs represent disease targets whose therapeutic modulation could revolutionize the way we treat immune diseases,” said Peter S. Linsley, Ph.D., chief scientific officer at Regulus. “We believe that we are the leaders in microRNA and are delighted to have such a good partner as GSK supporting the translation of our groundbreaking research into therapeutic opportunities. We are particularly pleased that this has been achieved in the first year of the collaboration.”

The alliance, which has a potential value of nearly $600 million, was established in April 2008. Regulus is responsible for the development of antagonists to four microRNA targets from discovery through completion of clinical proof of concept. GSK has an exclusive license for worldwide development and commercialization of drugs developed by Regulus under each program for the relevant microRNA.

Microtest Laboratories is adding dissolution testing to its current suite of analytical testing and stability testing services. Dissolution is a compendial method used to measure a drug’s rate of release from its dosage form. It is a complement to other analytical assays — potency and related substances — that characterize the dosage form.

“The addition of dissolution testing is the perfect complement to our portfolio of services,” said Steven Richter, Ph.D., president and scientific founder of Microtest Laboratories. “By offering an even more comprehensive array of assays, we’re increasing the convenience, efficiency, and value that we deliver as a single, preferred provider of contract laboratory services.”

Dissolution is typically used in a number of settings, including: optimization of drug delivery rate during development studies; routine QC analysis for lot release and measurement of lot-to-lot variability; stability studies to examine the effects of time, temperature, and humidity on the dosage form; comparison of one dosage form to another; and estimated release and absorption rates in humans after an in vitro - in vivo correlation is established.

Dissolution is a sample preparation technique. Samples still need to be analyzed separately. Typical samples are oral dosage forms, although it can also be used on topicals and transdermal systems. Microtest’s analytical testing processes follow guidelines from the United States Pharmacopeia (USP), the Japanese and European Pharmacopoeias, the FDA, the International Organization for Standardization (ISO), and the Association for Advancement of Medical Instrumentation (AAMI).

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