Pharma Contract Market Update

Contract services providers have announced recent facility and service expansions to stay on top of the latest advances and innovations to meet client and market demands. The following are significant expansions in facilities and capabilities that have occurred in recent months.

CordenPharma has expanded its solid-phase peptide manufacturing capacity at its Boulder, CO GMP API facility to accommodate in the demand for peptide APIs, and to continue an overall growth strategy, the company reported (1).

The expansion adds to the facility’s existing capabilities including a 10,000-L SPPS vessel and a 100-cm high-pressure reverse phase purification column. The company reported it can develop and manufacture APIs from laboratory scale to commercialization at ton scale.

Cambrex announced on July 1, 2020, that it has invested in an expansion of its flexible manufacturing facility in Sweden, which will increase the company’s drug substance manufacturing capacity by 25% by November 2020 (2).

The expansion will involve the modification of an existing four-reactor configuration, installation of new holding tanks and a 4-m² Hastelloy Rosemund filter, conversion of a manufacturing train, and will add a production line at 6-m³ scale.

Catalent has announced multiple expansions in this global network. The company has unveiled plans to invest US $30 million (EUR 27 million) to create a European center of excellence for clinical biologics formulation development and drug product fill/finish services at its facility in Limoges, France (3).

According to a July 21, 2020 press release, the project has gained support from the Prefecture of Haute-Vienne, the Metropolitan Area of Limoges, the Limoges Haute-Vienne Chamber of Commerce and Industry, and the Regional Council of Nouvelle Aquitaine through a grant worth EUR 1.3 million (US $1.5 million). The investment will see the Limoges site be fully modernized so that large molecule programs can be handled, in addition to extra capacity for small molecule dosage form development.

Modernization program includes the installation of an Optima high-speed flexible line capable of filling vials, syringes, or cartridges under barrier isolator technology, as well as enhancements to the analytical and quality control laboratories. Works on modernizing the Limoges site will start in September 2020 and are expected to be completed in 2022. Once complete, the Limoges site will work closely with Catalent’s other biologics facilities in Anagni, Italy; Brussels, Belgium; Bloomington, IN; and Madison, WI, to provide integrated clinical development and commercial manufacturing solutions.

On May 21, 2020, Catalent announced that it will acquire a clinical packaging facility located in Minakuchi, Japan, from Teva-Takeda Pharmaceuticals to further establish its good manufacturing practice manufacturing and distribution hub for clinical studies (4). Financial details of the acquisition were not disclosed.

The 60,000-ft2 facility will work in conjunction with the company’s Kakegawa, Japan, clinical supply facility to serve local and global biotech and pharmaceutical companies and will provide customers with Catalent’s FastChain demand-led supply services, primary and secondary packaging, temperature options for storage and distribution, and clinical returns and destruction services.

PCI Pharma Services announced on June 29, 2020 that it has completed the expansion of its Biotech Packaging Center of Excellence in Philadelphia, PA (5). The company also reported new investments its global biotech packaging capabilities at its operations in Ireland.

The expansions included enhancing high-speed automatic syringe assembly and labeling, vial labeling and cartoning, and auto-injector assembly. PCI also said it will build out its cold storage capabilities and manufacturing suites and provide design teams to address packaging challenges.

Emergent BioSolutions announced on June 18, 2020 that it will invest $75 million into its Canton, MA, facility to expand its viral vector, gene therapy, and contract development and manufacturing (CDMO) capabilities (6).

According to a company press release, the investment will include a state-of-the-art, multi-suite operation up to 1000-L scale. The investment also aligns with the company’s five-year growth plan which involves offering development services out of its Gaithersburg, MD, location, drug substance manufacturing out of Canton, and drug product manufacturing at its Rockville, MD, location.

Lonza has announced, in a July 1, 2020 press release, that it is making additional investments in its global particle engineering network for expanded capacity and specialized capabilities (7).

Significant expansions have been made at United States and European sites in jet milling and spray dry processing for development, so that the company can meet increased demand for these services. Further enhancements have been made in specialized processing capabilities.

At the Monteggio (Switzerland) micronization site, development capacity (non-GMP assets) has been doubled, including investment in a new glove-box for isolation, upgraded process controls, and expanded operator teams. Additionally, a new micronization development wing has been brought online at the Quakertown, PA (US) site, and a new pharmaceutical spray dryer dedicated to development projects has been added to the Bend, OR (US) site.

On July 8, 2020, Vetter announced that it is further investing in additional fill/finish capacity with the purchase of a clinical manufacturing site located in Austria (8).

The production site was purchased along with existing inventory, including a vial-filling line and a freeze dryer for liquid and lyophilized products, in addition to material preparation and laboratory equipment.

References

1. CordenPharma, “CDMO Expands US Peptide Manufacturing Capacity,” Press Release, July 7, 2020.
2. Cambrex, “Cambrex Announces Completion of Acquisition by the Permira Funds” Press Release, Dec. 4, 2019.
3. Catalent, “Catalent Biologics to Invest $30 Million to Create European Clinical Manufacturing Center of Excellence in Limoges, France,” Press Release, July 21, 2020.
4. Catalent, “Catalent Announces Acquisition of Japanese Facility to Provide Local and Global Clinical Supply Solutions,” Press Release, May 21, 2020.
5. PCI, “Completion of Biotech Packaging Center of Excellence in Philadelphia & Expansions in Europe,” Press Release, June 29, 2020.
6. Emergent, “Emergent Biosolutions to Invest $75 Million in Canton Site and Expand Viral Vector and Gene Therapy Capability,” Press Release, June 18, 2020.
7. Lonza, “Lonza Expands Particle Engineering Services,” Press Release, July 1, 2020.
8. Vetter, “Vetter Expands Fill/Finish Capacity with Acquisition of New Site in Austria,” Press Release, July 8, 2020.

Article Details

Pharmaceutical Technology
Supplement: Outsourcing Resources
August 2020
Pages: s34–s35

Citation

When referring to this article, please cite it as, “Pharma Contract Market Update," Pharmaceutical Technology Outsourcing Resources Supplement (August 2020).