Stevanato, Cambrex, Thermo Fisher, Lonza, Alcami, Marken Expanding

The latest from CDMOs, CMOs, and suppliers featuring Cambrex, Lonza, Thermo Fisher Scientific, Alcami, Stevanato Group, MilliporeSigma, and Marken.

Chemical/Chemical API Manufacturing

Cambrex Investing $30 M To Expand Small-Molecule-API Mfg Facility
Cambrex has announced plans to invest $30 million to expand its manufacturing facility in High Point, North Carolina. The facility provides process development, scale-up, and manufacturing of small-molecule active pharmaceutical ingredients and intermediates to support clinical trials from Phase I to Phase III. The announcement was made by the city of High Point.

The expansion will create 78 full-time jobs. The new positions will be created over the next three years (as reported on October 1, 2021) and will include operations, scientists, quality assurance and administrative personnel.

Source: City of High Point, North Carolina

Biologics Manufacturing

Thermo Fisher Moves Ahead on CSL-Partnered Biologics Mfg Site
Thermo Fisher Scientific has assumed operational responsibility for a new biologics manufacturing site, currently under construction, in Lengnau, Switzerland as part of its partnership with CSL Limited, a Melbourne, Australia-based bio/pharmaceutical company, The companies had announced the partnership last year (2020).

The Lengnau site will become part of Thermo Fisher’s global biologics manufacturing network, and approximately 200 employees will join Thermo Fisher. The site is a 1.5-million-square-foot facility that will use both single-use and stainless-steel bioreactors with up to 12,500 L of capacity.

Following completion of site construction in 2022, Thermo Fisher will initially support manufacturing of CSL’s recombinant factor IX product, Idelvion, which is used to treat hemophilia B. Over time, Thermo Fisher says it plans to expand the use of the site to include additional bio/pharma customers.,

Thermo Fisher’s biologics manufacturing network that includes sites in Princeton, New Jersey; St. Louis, Missouri; Groningen, the Netherlands; Brisbane, Australia; and Hangzhou, China.

Source: Thermo Fisher Scientific

Lonza Investing in Capacity, Staff for Mammalian Biologics in Singapore
Lonza has announced plans to expand its mammalian-based biologics development services at its site in Tuas, Singapore by adding additional capacity for cell culture, purification, and analytical services.

The company expanded its current laboratory capabilities by establishing a new 1,800-m2 laboratory, which began operations in September (September 2021). The company is also adding 70 employees to its mammalian development services team in Singapore to increase staffing to 125 employees. As part of the investment, the company’s existing laboratories at its Tuas, Singapore site will be upgraded by the end of 2021.

As part of the expansion, Lonza is investing in technology for mammalian process and analytical development through the addition of systems for cell-line development, perfusion, and process analytical technology for process development, as well as providing the capability to perform characterization of biopharmaceuticals using mass spectrometry.

Source: Lonza

MilliporeSigma To License CRISPR-Cas9 Technology to Cellecta
MilliporeSigma has agreed to license its CRISPR-Cas9 technology to Cellecta, a Mountain View, California-based genomics products and services provider.

Cellecta provides RNAi and CRISPR technologies for the discovery and characterization of therapeutic targets and genetic profiling for drug and biomarker discovery and validation. Cellecta plans to use MilliporeSigma’s CRISPR patent estate to offer CRISPR-mediated targeted “knock-in,” a method which gives scientists options for projects in therapeutic and disease research.

MilliporeSigma holds 40 CRISPR-related patents globally in methods and composition, including the CRISPR-Cas9 foundational technology for genetic integration in mammalian cells.

Source: Merck KGaA

Formulation Development/Drug-Product Manufacturing

Alcami Investing $31 M To Expand Sterile Mfg
Alcami, a CDMO of drug products and provider of analytical testing services, has announced a $31-million investment to expand its sterile development and manufacturing operations in Charleston, South Carolina.

The investment will add a second production line consisting of a vial washer and depyrogenation tunnel with an isolator filling line containing two lyophilizers. Also, the company invested in enhanced semi-automated visual inspection equipment to support the additional manufacturing capacity. The new equipment will be qualified and ready for contract cGMP manufacturing in 2022.

Alcami previously invested $17 million at its site in Charleston to expand development and manufacturing capacity with a new 1,000-L cGMP compounding suite.

In addition to the new equipment and increased capacity, Alcami also opened a 12,000-square-foot administration complex, and a 16,000-square-foot warehouse will be commissioned in 2022.

The company provides sterile fill-finish manufacturing for both vial and syringe filling from its sites in Charleston, South Carolina and Research Triangle Park, North Carolina.

Source: Alcami


Stevanato Group Investing $145 M for New US Mfg Facility
Stevanato Group, a provider of drug-containment, drug-delivery and diagnostic products and services, has announced an investment of $145 million to build a new manufacturing facility in Fishers, Indiana.

Construction on the new 370,000-square-feet facility will begin this month (October 2021) and is expected to be operational in 2023. The plant will support the expansion and production of Stevanato’s EZ-Fill syringes and vials.

Additionally, the company plans to use the new facility as a center for after-sales support by offering technical support and maintenance for visual inspection, assembly, and packaging equipment.

The company intends to hire more than 230 new local employees by the end of 2025 for roles in production, engineering, and maintenance, as well as other corporate support positions.

Source: Stevanato Group

Catalent Opens New Clinical Supply Facility in Japan
Catalent has opened a new 6,000-square-meter clinical supply facility in Shiga, Japan. The site provides primary and secondary packaging and labeling, storage and distribution, cold-chain handling, and in-country returns and destruction services.

Acquired from Teva-Takeda Pharmaceuticals in July 2020, the Shiga site has since undergone redevelopment and will also add specialized services for the Asia-Pacific markets, including Catalent’s FastChain supply, white-glove handling, and logistics services. The facility adds to the company’s Asia-Pacific supply network, which includes two sites in China and one in Singapore.

Source: Catalent


Marken Expands Global Cold-Chain Logistics Network
Marken, a provider of clinical-trial supply and logistics services and a subsidiary of UPS Healthcare, has expanded its global network for its clinical drug supply-chain services, particularly for cell and gene clinical trials.

Plans for the remainder of 2021 and 2022 will support mRNA therapies, cell and gene therapies, and early-access and managed-access programs. Expansion plans include new locations, expanded cold-chain services and packaging solutions for the following: (1) the addition of over 100,000 square feet of GMP-compliant depot operations in Louisville, Kentucky; Great Valley, Pennsylvania, and Seoul, South Korea; (2) a new GMP depot facility in Kiev, Ukraine; (3) a new GDP depot facility in Osaka, Japan; (4) new locations in Nairobi, Kenya and Accra, Ghana; (5) expansion of its kit assembly facility in Shanghai, China; (6) new liquid nitrogen (LN2) filling stations within each of its global cell and gene centers of excellence; (7) infrastructure expansion at its facilities in Belgium, France, South Africa, India, Taiwan, China, and Singapore; and (8) packaging and technology enhancements for real-time location tracking and temperature monitoring of cell-and gene-therapy shipments.

In addition to GMP storage, Marken says it will be able to track shipments for cell and gene therapies, compassionate-use products, and early-access programs from its Ukraine facility. This new control center, combined with the company’s existing control center in Durham, North Carolina, will enhance global monitoring of all complex shipments, including cell and gene shipments.

Source: Marken