NextPharma Technologies Partners With CARBOGEN AMCIS In Alliance Which Combines Investigational Medicinal Product And Active Pharmaceutical Ingredient Services For Highly Potent Active Pharmaceutical Ingredients
NextPharma, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotechnology industries, is pleased to announce that it has entered into an agreement with CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, to provide customers with seamless development services covering highly potent pharmaceutical ingredient (APIs) and Investigational Medicinal Products (IMPs) for clinical trials.
The alliance offers a complete range of services for customers for both APIs and IMPs from pre-clinical to Phase III clinical trials. The joint services will result in reduced cycle times, costs and risk related to the delivery of customer development projects. Sean Marett, Managing Director, NextPharma Technologies, Product Development Services commented: "Our customers are continuously looking at ways to speed-up development and reduce costs; this alliance moves customers one step closer towards achieving these goals".
IMP development services to be provided by NextPharma include pre-formulation, formulation design and optimisation studies, IMP analytical methods development and methods validation studies, manufacturing of IMP non-GMP batches for toxicology testing and of GMP batches for clinical trials, IMP process scale up and validation studies, IMP stability studies according to International Conference on Harmonization (ICH) guidelines, Clinical Trial Services including packaging, labeling, randomisation and distribution, and IMP QP release and regulatory support services (for dossier submission of the IMP).
Services to be provided by CARBOGEN AMCIS include API categorisation and or OEL establishment of APIs and Intermediates based on available toxicology data and chemical structure, API process research, process development, process hazards and calorimetric assessments, API analytical methods development, API analytical methods validation, manufacturing of API non-GMP batches (toxicology, pilot batches), manufacturing cGMP API, API process scale up, API stability studies according to ICH, API process validation, and regulatory support (for dossier submission) of the API.
"This alliance offers considerable added value to CARBOGEN AMCIS customers" commented Charlie Johnson, CARBOGEN AMCIS, High Potency Business Manager, "It's difficult to find reliable API production and IMP service companies in the high potency arena; this agreement eliminates that challenge for customers."
NextPharma develops, manufactures, packages, and distributes a broad range of products and formulations for its customers from tablets and capsules to antibiotics, hormones and controlled release medicines. It has an established leadership position in the high technology area of injectables manufacturing, with particular expertise in product development and manufacture of oncology medicines.
About CARBOGEN AMCIS AC
CARBOGEN AMCIS AC is a leading provider of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries through all stages of drug development. The integrated services of CARBOGEN AMCIS provide innovative, timely and safe drug development solutions that allow customers to make the best use of their available resources.
SOURCE: NextPharma