The new Alpha Biologics facility in Malaysia.
The Progenix facility will have its own primate building.
The new facilities are in the Bukit Minyak region on the north western coast of the peninsular.
Malaysia is trying to reinvent itself as a major biotech hub in Southeast Asia.
The production from the Alpha Biologics facility will be based on mammalian cell lines.

Penang Biotech Park is situated in the Bukit Minyak region of Malaysia in Penang (north-western coast of Peninsular Malaysia) and is playing host to two new biotech companies. The two companies are part of a $32m investment made by Springhill Bioventures from which two facilities have been constructed.

The two new plants started full-scale operations in 2008 following outfitting and validation; construction of the buildings was completed in October 2006. The facilities are managed by Alpha Biologics, based in Malaysia and the UK, main investors: SpringHill BioVentures, Asiaprise Biotech and Pequot; and Progenix.

Both of the plants provide training for graduates in the biotech field. However Alpha Biologics concentrates on the production of pre-commercial scale pre-clinical trial drugs (completed in June 2007 and now employs around 25 staff) and Progenix specialises in preclinical R&D work (completed in March 2007).

Contractors

The construction of the new plants was undertaken by Goodtrend, which was appointed by Boccard of France (this company produces tanks, reactors and skid-mounted production modules for a range of industries). Goodtrend was appointed in November 2005 and has a vast amount of experience in the construction of ISO, GMP, HACCP and HALAL compliant facilities.

“Both of the plants provide training for graduates in the biotech field.”

The construction of the buildings was completed in October 2006 and the cleanroom installation for Alpha Biologics began in November 2006. The plant was commissioned in April 2010. The multi-product Alpha facility operates stirred tank reaction vessels, ranging from 10l to 500l, and also uses perfusion technology – this results in a 20 times increase in productivity per reaction vessel.

Alpha Biologics also develops stable cell lines and Master and Manufacturing Working Cell Banks prior to the start of cGMP manufacture. There is also a cell line storage services provided so that repeat manufacture of drugs can occur with little delay. Both upstream process development and downstream process (purification) development at the Penang facility.

Finance

In November 2006 Alpha Biologics announced further investment of $3m from US-based Pequot Capital Management for the construction of the new 5,000m² facility in the Penang Biotech Park. The facility cost a total of $18m to construct and outfit.

Alpha Biologics

Alpha Biologics was set up in 2003 with the aid of the Penang Development Corporation (PDC) and Malaysian Industrial Development Authority (MIDA). The company will concentrate on providing services to biopharma and pharmaceutical companies by supporting the development of biologic drugs through pre-clinical, phase 1 and phase 2 trials.

“Alpha Biologics in mammalian cell expressed peptide and antibody drugs.”

The company specialises in mammalian cell expressed peptide and antibody drugs and the facilities used in full compliance with US Food and Drug Administation and European Medicines Agency requirements.

In January 2007 Alpha Biologics acquired CTM Biotech of the UK, following which the UK headquarters of Alpha Biologics was relocated to the CTM facility in Babraham Research campus, Cambridge, UK.

Progenix

Progenix Research is an independent contract research organisation with a new laboratory facility in Penang, Malaysia. There are facilities for toxicology, which will include studies on pharmaceuticals, biotechnology products, medical devices, food, agrochemicals, biocides and other chemicals. Building of the Progenix R&D facility began in early 2005.

The Progenix facility consists of four buildings including: two storey offices/laboratories (offices, canteen, reception, archive); a 3,200m² rodent facility with 40 animal houses, a primate building with eight animal rooms (capacity for 288 macaque monkeys), and a state-of-the-art canine building with 15 animal rooms and a total capacity of 540 dogs.