American Peptide will highlight its cGMP (current Good Manufacturing Practice) peptide manufacturing capabilities at CPhI Worldwide, 13-15 October, 2009, in Feria de Madrid, Spain.
The company's compliance with cGMP guidelines ensures quality peptide products for therapeutic and diagnostic applications from the clinical-trial phase to commercialisation.
High-quality peptides help drug manufacturers realise improved consistency, with higher yields and reliable final product quality.
At American Peptide Company's cGMP manufacturing facility in Vista, California, all facilities, procedures, and documentation are maintained in accordance with GMP standards as defined by the US Code of Federal Regulations.
The company mandates application of cGMP practices to non-cGMP applications in the early phases of drug development to provide drug researchers with manufacturing processes that can be scaled up efficiently.
To better meet the needs of its growing base of customers, the company recently embarked upon a facility expansion at its Vista, California, location, increasing large-scale GMP peptide production capacity.
The expansion includes the construction of peptide-purification and synthesis suites.
Large-scale synthesis suites for both solution-phase and solid-phase peptide synthesis are also planned as part of the expansion.
The company conducts both solution-phase and solid-phase synthesis at the same facility, which minimises risks associated with technology transfer, process development and pilot scale-up.
The facility has the capacity to synthesise gram to multi-kilogram quantities of peptides.
