Contract manufacturing news in brief
recently announced new contract manufacturing deals.
Baxter Biopharma Solutions said it has completed the expansion of its lyophilisation capacity at its cytotoxic contract manufacturing facility in Halle, Germany. The expansion which was announced last December brings the company's number of dedicated lyophilisers to four, as the company has added two large-scale lyophilisation units to freeze-dry cancer therapy drugs. The expansion also includes innovative technologies to safely handle organic solvents including a state-of-the-art fully automated loading cart and in-process quality analysis technology. The cart navigates in the building with sensors, transporting the cytotoxic vials from filling without human attendance, and auto-loads the freeze driers. Meanwhile, US firm arGentis Pharmaceuticals has signed a deal with Tennessee-based company LifeCyte to design and develop a manufacturing facility that will purify commercial quantities of arGentis' collagen products portfolio. The new current good manufacturing practice (cGMP) plant will be used to purify bovine native type 1 collagen for use in ARG201, arGentis' treatment for systemic sclerosis (SSc) expected to enter Phase III trial next year. arGentis will also produce various types of highly purified (greater than 98 per cent) collagen used for the research and the medical device industries. LifeCyte is working with arGentis on process development, facility design, quality assurance and control, and implementing standard operating procedures to meet regulatory guidelines. arGentis has started its site selection process for the new facility and will finalise the location over the next several months. "arGentis' plan is to move the collagen production process from the laboratory into a facility that can purify commercial quantities," said Tom Davis, CEO of arGentis. "In addition, the purity and variety of collagens that will be produced at the cGMP facility also affords us a revenue opportunity by providing highly purified collagen to the research and medical device markets." In other news, Michigan-based Meditrina Pharmaceuticals, has announced it has signed a contract manufacturing deal with a unit of Pfizer CentreSource (PCS), a leading supplier of active pharmaceutical ingredients (APIs). The agreement covers the supply of Meditrina's lead product candidate Femathina (MPI-674) which is currently in Phase II clinical trials. MPI-674 is an aromatase inhibitor that Meditrina is repurposing for the treatment of several serious women's health conditions. "Securing a high-quality commercial supply chain partner has been a key focus of the organisation and represents an important milestone in advancing our product development programme," said Holly Vene, COO and vice president of business development at Meditrina.
