Optimizing Early-Stage Drug Development - Pharmaceutical Technology

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PharmTech Europe

Optimizing Early-Stage Drug Development
Pharmaceutical companies and contract service providers adapt strategies and capabilities to reduce costs and accelerate drug-development timelines.

Pharmaceutical Technology
Volume 36, Issue 11, pp. 32-37

Aligning contract services

Collaborative models for drug development
As pharmaceutical companies adjust their development strategies, contract service providers are responding in kind to provide targeted services for early-stage development. For example, in October 2012, Catalent Pharma Solutions formed a global alliance with the CRO Parexel to help streamline the clinical-trial supply process. The formation of this alliance follows Catalent's February 2012 acquisition of the clinical-trial supplies business of Aptuit. In August 2011, Bend Research and Xcelience formed a collaboration to provide oral solid-solubilization formulation solutions for early-phase development. In February 2012, Covance signed a three-year, exclusive integrated drug development agreement with BioPontis Alliance to manage early development of scientific discoveries from academia.

Almac's solid-state services group recently created a series of preclinical screening packages for clients to identify their candidate's chances of success much quicker than using traditional mechanisms. Experimental efforts concentrate on establishing the physical, chemical, solubility, stability, and polymorphic characteristics of each drug candidate. Separately, Almac launched a qualified person facilitation program that is designed for clients importing investigational medicinal products into the European Union for clinical trials.

EMD Millipore announced the opening of its advanced GMP bioproduction facility in Martillac, France, which will serve users of EMD Millipore's Provantage biodevelopment and clinical supply solutions, an open-source manufacturing option for upstream and downstream processes. The open-source approach is designed to provide customers with greater control over production. The facility offers GMP production of mammalian proteins for preclinical to Phase II production at 50 L to 1250 L scales. For Phase III and commercial production, customers can transfer manufacturing at any scale.

Companies are augmenting their testing services to support early-drug development. In June 2012, Metanomics Health, part of BASF, launched MetaMap Tox, a service evaluating specific metabolomic patterns in vivo, enabling customers to better and faster identify potential safety risks of test compounds in in vivo studies of rats. SAFC a contract API manufacturer and providers of biosciences services and products, acquired BioReliance, a provider of biopharmaceutical testing services for $350 million. BioReliance provides biologic, specialized toxicology, and animal-health testing.


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