ALPHA BIOLOGICS SDN. BHD.
Plot 302, Taman Perindustrian Bukit MInyak,
Seberang Perai Tengah,
14100 Penang,
Malaysia.
Product & Services :
Alpha Biologics is a contract bio-manufacturing organisation offering process development and FDA/EMEA cGMP compliant services to the worldwide pharmaceutical and biotechnology industry. Initial process development is undertaken by Alpha's highly experienced team in Cambridge, UK, before being transferred to the 5,000 sq meter facility in Malaysia for final process technology transfer and manufacturing of biologics drugs for pre-clinical and clinical trials. The facility has been designed to produce primarily mammalian cell secreted proteins, including monoclonal antibodies and recombinant proteins. Managed by a team of specialists with significant cGMP manufacturing experience in the US, Europe and Asia that will ensure the highest standards of production and regulatory compliance. Future expansion plans in two stages are to add a 'fill/finish' operation and a microbial cell facility.
We specialize in the production of mammalian cell secreted protein drugs, and we provide all of the necessary services required to develop and produce our clients' drugs in full compliance with U.S. and European cGMP guidelines. Our manufacturing base in Malaysia brings significant cost advantages to our customers due to the lower overhead costs compared with Europe or the U.S., whilst maintaining the highest standards of compliance. Our core team has extensive experience of designing, building and operating cGMP compliant facilities for biologic drugs in the U.S. and Europe. The core team comprises internationally trained and experienced staff from the world-wide biologics industry and academia. Our goal is to deliver drugs on time for clinical trials at a price that is affordable, thereby enabling our clients' to maintain strong drug development pipelines and realize maximum value from the investments in research and development.
