Building a technology position is crucial for competitive advantage in the market for contract API manufacturing. The author examines recent investment activity in small-molecule and biologics manufacturing.

As contract manufacturers, fine-chemical companies, and technology providers gather for CPhI/ICSE, the large trade show of pharmaceutical ingredients, in Frankfurt next month, a basic, but important question is how the market for contract API manufacturing and related services is performing. One barometer is investment by outsourcing providers. Within the small-molecule sector, although some companies are proceeding with general capacity additions, most are focusing on investment in specialized technologies, such as high-potency manufacturing and chemocatalysis and biocatalysis. An active area of investment is biologics, where several companies have recently made acquisitions or are investing to enhance their capabilities.

Building strength in technologies and capacity

At its biopharmaceutical facility in Slough, United Kingdom, Lonza is investing £16 million ($26.1 million) to build a new 60,000-ft² building to house fermentation and purification suites, process-development laboratories, and a GMP warehouse. The project is expected to be completed by the end of 2012. The Slough site manufactures antibodies and therapeutic proteins.

Lonza also is expanding its viral-manufacturing business. The company is constructing a new cleanroom to support late-stage viral-vaccine and gene-therapy projects at its facility in Houston. The expansion will support production and fill–finish operations for volumes as large as 2000 L. Construction and validation of the facility are expected to be completed by early 2012.

Lonza also is investing CHF 24 million ($30.2 million) to expand cytotoxic manufacturing capabilities at its fine-chemicals facilities in Visp, Switzerland. The company operates high-potency GMP laboratory suites on a gram scale. The investment will add multikilogram-scale cytotoxic capacity for clinical and commercial production. The expansion, which will include fermentation and chemical capabilities, is expected to be completed in the second quarter of 2012.

SAFC completed an expansion of its high-potency fermentation facility in Jerusalem in 2010. The 50,000-ft² cGMP expansion is focused on niche fermentation of APIs and bulk drugs, secondary metabolites, cytotoxins, and large-molecule proteins. A 30,000-ft² area of the new facility was designed to comply with Biosafety Level 2 levels, which allows for the manipulation of human pathogens. Capabilities include 1000- and 4000-L tank capacities for bacterial and fungal fermentation. The facility uses E. coli, Streptomyces sp., filamentous fungi, and yeast, including risk Group 2 human pathogens. The facility produces small molecules, peptides, proteins, lipids, carbohydrates, and other macromolecules.

In June 2011, SAFC formed a nonexclusive strategic partnership with the protein-production company Pfēnex under which Pfēnex will manage production strains and processes for SAFC's contract-manufacturing customers. The developed processes will be transferred to SAFC's recently expanded fermentation facility in Jerusalem for cGMP production. The Pfēnex Expression Technology platform is based on the microorganism Pseudomonas fluorescens for producing research proteins, reagent proteins, biosimilars, and innovator biopharmaceuticals. SAFC and Pfēnex also plan to combine Pfēnex's reagent proteins product offerings in vaccine components with SAFC's expertise and facilities for bioconjugation to support the development of conjugate vaccines.

In February 2011, Pfēnex granted Boehringer Ingelheim nonexclusive access to the Pfēnex Expression Technology. Under the multiyear agreement, Pfēnex will engineer production strains and processes for Boehringer Ingelheim's proprietary molecules and molecules from Boehringer Ingelheim's contract-manufacturing customers.