Catalent, Alcami Expand; Sekisui To Invest $19 M in Microbial Capacity

The latest from CDMOs, CMOs, and suppliers featuring Catalent, Alcami, Colorcon, and Sekisui Diagnostics

Biologics Manufacturing

Sekisui Diagnostics To Invest $19 M in Microbial Capacity
Sekisui Diagnostics, a provider of enzymes and contract process development and biomanufacturing services, plans to invest £14.4 million ($19 million) in its biopharma CDMO business to expand microbial capacity at its existing site in Maidstone, Kent, UK. The expansion is scheduled to be completed by the second half of 2022.

The facility expansion and upgrades will allow for drug-substance contract manufacturing a clinical scale. The new microbial fermentation and purification suites will accommodate production scales up to 1,000 L to complement existing capabilities that range from 20 L to 5,000 L.

The planned expansion follows the investment of $1.9 million in a new Bioprocess Innovation Center, which was completed in October 2019.

Previously part of Genzyme Corporation, Sekisui Diagnostics’ enzyme business launched its microbial biopharma CDMO service offering in 2017.

Source: Sekisui Diagnostics

Catalent Gets FDA OK for Mfg Site for Novartis’ Gene Therapy
Catalent has been approved by the US Food and Drug Administration (FDA) to produce a commercial drug-substance intermediate at its manufacturing facility in Harmans, Maryland for a gene therapy of Novartis’ AveXis for treating spinal muscular atrophy.

The approval comes after an FDA inspection of the Harmans commercial-scale gene-therapy manufacturing center in June 2020. Since Catalent’s partnership with AveXis, a Novartis company, was announced in July 2019, dedicated suite space has been prepared at the Harmans facility for the commercial manufacture of this adeno-associated virus (AAV) gene therapy.

Catalent’s Harmans commercial manufacturing facility is equipped with single-use technology and houses over 200,000 square feet of late-stage clinical and commercial-stage gene-therapy production. The facility is one of Catalent’s five gene-therapy facilities in Maryland providing clinical through commercial scale services and houses multiple manufacturing suites, including fill–finish, central services and testing laboratories, warehousing, and supply-chain capabilities.

Source: Catalent

Formulation Development/Drug-Product Manufacturing

Catalent To Add High-Potency Mfg for Softgels in Argentina
Catalent has announced plans to expand its site in Loma Hermosa, Buenos Aires, Argentina by adding over 11,000 square feet of production space to handle cytotoxic and highly active products for prescription softgel manufacturing.

The new facilities, which are due to be completed in December 2021, will include two new manufacturing vessels of 40 L and 300 L, which include an automatic cleaning system and a mixing device suitable for very high viscosity formulations, a capsule-filling line, and six drying tunnels. The expansion will add a capacity of over 10 million doses per annum to the site, which supplies products to the Latin American, US, and European markets.

Catalent’s 265,000-square-foot-facility in Buenos Aires houses softgel manufacturing operations with a full range of development services from formulation to packaging.

Source: Catalent

Alcami Nears Completion of Expansion in North Carolina
Alcami, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has announced its 56,000-square-foot expansion in Research Triangle Park, North Carolina has reached the first milestone of operational readiness with the start of GMP laboratory testing this month (August 2020).

The site became part of Alcami when it acquired TriPharm Services, a CDMO, earlier this year (January 2020). TriPharm had commissioned a new manufacturing center for sterile fill–finish services. The site feature 20,000 square feet dedicated to microbiology, formulation development, and analytical chemistry services. Specific investment has been made to offer environmental monitoring services from this site in 2020. Operational capabilities will continue to build across the next two years with the completion of Phase I of the manufacturing facility in the fourth quarter of 2020, which will bring the first two filling suites on line and the next major milestone.

In support of this build-up, Alcami has added more than 30 employees to the Research Triangle Park campus and 80 employees company-wide in 2020. The company says recruiting is ongoing for more than 60 additional positions across all Alcami sites. Alcami is working with the US Food and Drug Administration (FDA) to combine the new site with an existing Alcami laboratory located in Durham, North Carolina, under a single FDA establishment identifier. The Research Triangle Park laboratory and manufacturing operations are integrated under Alcami’s established quality systems and oversight.

Source: Alcami

Colorcon Opens New Technical Center in Melbourne
Colorcon, a developer of film-coating systems and excipients, has opened a new technical center in Melbourne, Australia for pharmaceutical class development services such as tablet formulation and coatings.

Source: Colorcon

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