Baxter is expanding its lyophilisation capacity at its German facility to support future growth of its contract manufacturing business for anti-cancer drugs.
Lyophilisation, or freeze-drying, is a real money spinner for the contract manufacturing industry, and demand is expecting to increase significantly as more and more biological drugs come to the market, in particular cytotoxic, or anti-cancer drugs. Freeze-drying a protein or a peptide-based drug keeps it in a stable form until it is reconstituted just prior to administration, and is therefore one of the quickest routes to developing a biological product for administration to patients.
Because the lyophilisation process requires a high degree of automation, contract manufacturing organisations (CMOs) are focusing on tapping this large demand for such specialised niche technologies.
CMOs, like Baxter BioPharma Solutions (BPS), have spotted the opportunity in the market, and have been building state-of-the-art facilities that rival those of drug makers and are constantly upgrading them to enable novel manufacturing processes.
Baxter said the new expansion will have two large-scale lyophilisation chambers added in order to freeze-dry cancer therapies for the company's pharma and biotech partners.
The new expansion, expected to be fully completed and validated by mid-2007, will include innovative technologies designed to "optimise product quality and safety, while reducing risk of compromising product integrity", the firm said.
"We are expanding to meet the growing demands of the cytotoxic manufacturing market," said Tom Polen, senior director of marketing for BPS.
"As a leader in the industry, we look forward to providing greater capacity and continue to advance our track record for delivering safe, high-quality products for our customers."
The manufacturing site in Halle, Germany, is one of the most advanced facilities for cytotoxic contract manufacturing in the world, the firm claims.
In addition, BPS already uses a proprietary vial washing process that has been shown to nearly eliminate external contamination of chemotherapy vials, and all the products made at the Halle facility benefit from this method.
The value of the cytotoxic drug market in the seven major pharmaceutical markets is $9.6bn (€7.2bn), according to recent data, and Baxter said that it is predicted that 65 per cent of cytotoxic drugs will be outsourced compared to only 30 per cent of non-cytotoxic products.