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Good manufacturing practice
IRVINE, Calif.óContract research and manufacturing services firm Viropro Inc. has signed a $21 million deal to acquire Alpha Biologics of Penang, Malaysia, through a share purchase agreement. The acquisition will involve issuance of 525 million shares valued at 4 cents each.
Alpha Biologics is a contract process development and GMP biomanufacturing company, with R&D and bioprocess development laboratories located in the Babraham Research Campus in Cambridge, United Kingdom, and a state-of-the-art, 5,000 square-meter advanced GMP mammalian cell clinical production facility with 30 employees located in the Penang Science Park, Malaysia. Alpha Biologics provides its clients with contract manufacturing services, including supplies of mammalian cell proteins, such as monoclonal antibodies or recombinant proteins, or other cell-derived products.
Based on the agreement, Viropro acquires Alpha's state-of-the-art advanced good manufacturing practice (GMP) mammalian cell production facility at its headquarters at the Penang Science Park, which was the key to the deal, according to Dr. Rajiv Datar, Viropro's president and CEO. Viropro also gains access to Alpha's new Cambridge process development lab, which was designed to complement the Penang facility. The Cambridge lab produces supplies of mammalian cell proteins, such as monoclonal antibodies and recombinant proteins.
Both the Cambridge and Penang sites were recently the subjects of multimillion-dollar upgrades designed to ease the path of clinical trials and the commercialization process for Alpha's international clients. Over the next few months, the plant will undergo due process to obtain its certification under the Pharmaceutical Inspection Cooperation Scheme (PIC/s), which is a global harmonization scheme for Good Manufacturing Practices (GMP) with 39 member countries and agencies, including the U.S. Food and Drug Administration (FDA). Datar expects Alpha's U.K. plant to receive certification this year, with the European Medicines Agency (EMEA) accreditation following shortly thereafter.
Datar says Viropro intends to make more acquisitions as it seeks new partnerships for its biosimilar cell lines and manufacturing processes. Specifically, he cites the addition of a recombinant bacterial line and a protein analysis lab as early moves. The company already enjoys a strong position in markets such as South America, Asia and Eastern Europe.
"With this acquisition," Datar says, "Viropro has taken the first step towards creating a global biotech contract services business, and towards achieving our goal of offering an integrated contract development and GMP manufacturing services platform to our clients in the biopharmaceutical industry. We expect to expand our customer base dramatically and anticipate further acquisitions as we make progress."
Datar notes that the firm of SpringHill Management Ltd. in the United Kingdom has been an important supporter of its acquisition strategy.
Dato Kim Tan, chairman of SpringHill Management and of Alpha Biologics, adds, "This transaction allows us to participate in the entire biotech contract development and manufacturing services offering, and thus provides increased leverage to our Penang facility. We look forward to working closely with Viropro and its other subsidiaries towards the realization of a common mission, which is to make biotech drugs for clients, efficiently and economically."