Excipients and Formulation Development at Focus at CPhI

Highlights from CPhI Worldwide and recent news show excipient manufacturers, CDMOs, and CMOs expanding through new product and service offerings, capacity expansions, and acquisitions.

The CDMO Aenova Group has agreed to acquire the CDMO Haupt Pharma. Financial terms were not disclosed, and the deal is expected to close at the end of 2013. The merger will add areas such as sterile manufacturing and the production of special active ingredients, including hormones, antibiotics and cytostatics, to Aenova’s existing range of solid, semisolid, and liquid dosage forms. The Aenova Group’s existing production network will increase from eight to 21 sites. In addition to new production facilities in Germany (Berlin, Brackenheim, Münster, Gronau, Regensburg, and Wolfratshausen) and in Europe, Aenova will also acquire its first site in Asia (Japan). The number of employees will increase from 2500 to more than 4000.

The CDMO Aesica Pharmaceuticals and the Japanese CDMO CMIC have signed a memorandum of understanding for the reciprocal development of sales and marketing opportunities for respective clients in Europe and Japan. Furthermore, both companies will work closely together to develop commercial opportunities across the US market. This initiative will form the initial basis of a supply and quality agreement.

In other news, Aesica plans opening a new inhalation Lead Technical Center by the end of 2014. Aesica also extended its aseptic capabilities at its site in Nottingham, the United Kingdom with the acquisition of new prefilled-syringes manufacturing equipment capable of processing 5000 units/batch. This latest addition is undergoing validation via process simulation, and validation is expected to be completed by January 2014.

Almac reports several recent developments. In January 2013, Almac completed the doubling of its pharmaceutical development service capabilities with the opening of a new dedicated non-GMP facility and two analytical laboratories at its UK headquarters. In parallel to the new non-GMP facility, Almac doubled its analytical capacity with new analytical laboratories for processing large sample sets that result from non-GMP process development work for clients who seek to better understand their processes in line with the principles of quality by design. Additionally, in response to increased demand for preclinical and early-phase clinical GMP supply, Almac has added to its pharmaceutical development offering with an investment in additional Xcelodose technology, which provides the capability to dose potent APIs directly into capsules. Also, Novozymes Biopharma, part of Novozymes, has formed a new collaboration with Almac to provide a combined service for drug-development applications in the field of drug targeting and pharmacokinetic improvements. The collaboration will combined Almac’s manufacturing assets and protein conjugation capability to link Novozymes’ Recombumin Flex technology to peptide and small-molecule drugs. Collaborations with commercial partners have already begun and will continue to expand in early 2014.

Colorcon and Evonik have formed a cooperation agreement for the market promotion and technical support of the Acryl-EZE aqueous acrylic enteric system. The Acryl-EZE system, used for the application of an enteric film coating for oral solid dosage forms, was originally codeveloped by the two companies. It combines Evonik’s enteric polymer, EUDRAGIT L 100-55, with a fully or partially formulated coating system from Colorcon. Prior to this new cooperation agreement, the product was produced, distributed, marketed, and supported solely by Colorcon to the pharmaceutical industry. From now on, customers with enteric coating projects will have access to nine technology centers of Evonik and twenty technical services laboratories of Colorcon globally.

The Controlled Release Alliance between Colorcon and Dow Pharma and Food Solutions has introduced new grades of flowing METHOCEL Premium Cellulose Ethers for direct compression and dry-granulation applications. METHOCEL DC2 is the latest addition to cellulose ethers manufactured by Dow. It is designed to enhance material flow from the blender to the tablet press through a proprietary technology to change the fibrous morphology of traditional METHOCEL materials to a more spherical shape to form an easy-flowing powder.

Capsugel’s Dosage Form Solutions business unit will upgrade and expand three of its manufacturing facilities in the United States and Europe. The multimillion-dollar investments broaden the company’s global capabilities to handle hormonal as well as high-potent compounds for soft gelatin and liquid-fill hard capsules. The expansions are part of the implementation of its Lipidex technology platform, which was launched in June 2013.

IDT Biologika, a producer of proprietary and third-party biopharmaceuticals and viral and bacterial vaccines, and Oncotec Pharma Produktion announced investments for increasing their respective production capacities. IDT will invest an additional EUR 40 million ($55 million) in its vaccine and parenteral sterile fill-and-finish capacities in syringes, vials, lyophilization and packaging at its BioPharmaPark, located in Dessau-Roβlau. Among the upgrades are serialization and anticounterfeiting capabilities. In September 2013, IDT started up its new production capacity dedicated to sterile parenteral drug products, including vaccines and biologics, having completed an expansion project announced in 2011. Capacity to manufacture vial-based products in liquid and lyophilized form will increase to 60 million units per year. Oncotec Pharma Produktion, a pharmaceutical manufacturing partner of aseptically produced cytostatic drug products, recently announced an EUR 30-million ($41-million) investment to expand sterile parenteral oncology drug manufacturing capacity within IDT’s BioPharmaPark. The expansion projects are expected to be completed in 2016.

Vetter is investing more than $100 million across its production sites in Germany and the United States to expand and upgrade its facilities to expand filling capacity. Two new filling lines are currently being designed for Vetter's Ravensburg South facility in Germany. The new lines will fill liquid cartridges and vials and will add to the production site’s current lines, one of which is a syringe line that was launched in the spring of 2013. At Vetter’s US clinical manufacturing facility in Chicago, a third filling line for prefilled syringes is nearing completion. Expected to be operational in 2014, the new clinical line will have a maximum batch size of 30,000.