WuXi AppTec recently completed construction of a new GMP manufacturing facility that employs disposable systems, including 1,000 L bioreactors.
“The entire operation employs disposable systems, both upstream and downstream, which greatly facilitates product changeovers, while reducing operational costs,” said David Fischer, business development manager, protein therapeutics at WuXi AppTec.
“We also will be expanding our disposable bioreactor capacity to 2,000 L by the end of the second quarter in 2013.”
In addition to investing in single-use technologies to meet customer demands for shorter project timelines, a few CMOs have been investing in fill-and-finish capacity. These CMOs are able to provide their clients with a one-stop-shop solution thereby reducing the logistics and coordination between two different CMOs. This helps speed delivery of clients’ drug product.
Laureate Biopharma, Boehringer Ingelheim and WuXi Apptec have recently made investments in fill-and-finish services.
Laureate completed improvements to its formulation and filling operations, including new analytics for formulation development and upgrades to its fill suites, resulting in improved process flow.
“Laureate has invested $8 million in its manufacturing facilities and equipment, quality systems, and analytical equipment,” said Lisa Cozza, vp of business development.
Other CMOs are also undertaking initiatives to improve product timelines for their customers. CMOs are adopting tools and techniques that will speed cell-line development, and facilitate their clients’ clinical studies. For example, CMC Biologics is offering faster cell-line development services.
“Our custom CHEF1® cell-line development platform provides expression solutions for both monoclonal antibodies and glycoprotein production,” said Claes Glassell, CEO. “The platform has been designed to deliver clonal research cell banks capable of producing more than 2 g/L of recombinant antibody in 12 weeks from transfection.”
CMC has also recently offered a new program to its clients that it reports delivers clinical-scale monoclonal antibodies in 12 months.
Also working to reduce project timelines for its clients, Gallus recently announced that it has begun to collaborate with Theorem Clinical Research to provide their clients with seamless integration between their CRO and the contract manufacturer. This collaboration streamlines the clinical studies activities with manufacturing development and production.
“This addresses a flaw in the current industry norm where CRO and CMO services are not linked and yet there is a vital role to play in delivering efficient and effective clinical development to clients,” said Mark R. Bamforth, president and CEO at Gallus Biopharmaceuticals.
CMOs continue to implement new capabilities that either speed product development or improve product quality.
“Sandoz has successfully implemented its microbial autoprotease fusion expression technology (Npro) for two clinical candidates at 1,300 L and 3,000 L scale. The technology is available for partners of Sandoz,” said Friedrich Nachtmann, Ph.D., head of biotech cooperation at Sandoz.
Sandoz recently scaled-up the PEGylation of proteins to the 13,000 L scale and successfully integrated this process into its downstream manufacturing operations.
In order to meet customers’ demands for better formulations, Wacker Biotech offers an alternative to PEGylation processes in cooperation with XL-protein.
“Many customers are currently looking for better formulations and, in particular, for technologies to improve the plasma half-life of biopharmaceuticals to reduce the dosing frequency,” explained Thomas Maier, Ph.D., managing director of Wacker Biotech.
“In contrast to the established chemical modification of the drug molecule with polyethyleneglycol (PEGylation), the new technology, PASylation®, offers a means to genetically fuse the therapeutic protein with a nonimmunogenic polypeptide comprising proline (P), alanine (A), and serine (S) residues and so increase the hydrodynamic volume.”
“PASylation has the advantage of avoiding an expensive and poorly selective chemical modification step during production and eliminates the need of additional purification. Moreover, unlike the chemical polymer PEG, the PAS amino acid sequences are biodegradable and therefore do not accumulate in cells or organs. We have already reached high production titers of 3 to 4 g/L for PASylated human growth hormone.”