Monday, 7 February 2011

Expanding integrated analytical services for drug substances and products

CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has expanded its service portfolio and capacity for stability studies. In compliance with the latest International Conference on Harmonisation (ICH) guidelines, and in response to customer demand, the company has installed new stability chambers at the Hunzenschwil (Neuland), Switzerland operations and offers short-term, long-term, accelerated, intermediate, follow-up and customized tests.

CARBOGEN AMCIS’ new fully validated and mapped stability chambers <> operate at ICH conditions (25°C/60% RH, 30°C/65% RH, and 40°C/75% RH) and at low temperatures (5°C, -20°C and -80°C). With a current shelf storage capacity of about 92 m2, they provide secure and safe storage for APIs’ samples, including highly potent material, employed for in-house stability studies.
“The installation of new state-of-the-art stability chambers strongly enhances CARBOGEN AMCIS’ service portfolio and confirms our ongoing commitment in providing our customers with the best innovative, timely and safe drug development solutions,” said Brian O’Neill, CARBOGEN AMCIS AG sales manager. "We are facing an increasing customer demand for stability studies, as a stand-alone service or tied to our API development and production efforts. This expansion meets our customers’ needs.”

With the backing of a comprehensive range of analytical techniques <> and solid state services for drug substances and products, including highly potent compounds, CARBOGEN AMCIS can offer standard or customized stability protocols covering stability testing, forced degradation tests (under acid or alkaline conditions), oxidative stress testing, photostability studies, method development and validation, detection of degradation products, and pre-formulation studies. For the development and supply of APIs, including highly potent compounds, from early stage through to commercial phase, CARBOGEN AMCIS employs more than 300 expert scientists knowledgeable in drug research, analytical development and quality control.