The latest from CDMOs, CMOs, and suppliers featuring Samsung Biologics, Cambrex, Dipharma, Thermo Fisher Scientific, Ginkgo Bioworks, and Logistics4Pharma.

Chemicals/Chemical API Manufacturing
* Dipharma Gets OK from Italian Authorities for New API Mfg Line
* Merck & Co., Ginkgo Bioworks in Biocatalysis Pact
Biologics Mfg
* Samsung Biologics Begins Ops at New Biomanufacturing Facility
General
* Thermo Fisher Opens Clinical Research Lab
* Cambrex Expanding Stability Storage Capacity
* Logistics4Pharma Expands Deep-Freeze Storage

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Chemicals/Chemical API Manufacturing

Dipharma Gets OK from Italian Authorities for New API Mfg Line
Dipharma, a Milan, Italy-based CDMO of active pharmaceutical ingredients and intermediates, reports that the Italian Medicines Agency has approved a new production line in its cGMP pilot plant suite at its facility in Mereto di Tomba, Italy.

The expansion doubles the company’s capacity at the pilot plant, which now consists of two independent production lines that can produce batches ranging from 5 to 50 kilograms. The expansion includes the addition of two glass-lined and two stainless-steel reactors, along with a Hastelloy C-22 filter-dryer.

Source: Dipharma

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Merck & Co., Ginkgo Bioworks in Biocatalysis Pact
Merck & Co. has formed a collaboration, worth up to $144 million, with Ginkgo Bioworks, a Boston-based biotechnology company specializing in cell engineering for industrial applications, to develop biocatalysts for active pharmaceutical ingredient (API) manufacturing

Under the agreement, Ginkgo Bioworks will engineer up to four enzymes for use as biocatalysts in Merck & Co.’s API manufacturing. Ginkgo will earn an upfront research and development fee and is eligible for success-based research and development milestone payments. In addition, Ginkgo is eligible to earn commercial milestone payments for each of a specified number of biocatalysis targets, which have the potential to total up to $144 million.

Source: Ginkgo Bioworks

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Biologics Manufacturing

Samsung Biologics Begins Operations at New Biomanufacturing Facility
Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, announced that its fourth biomanufacturing plant has commenced partial GMP operations this month (October 2022).

The partial opening adds 60,000 liters of production capacity. The plant will have a total capacity of 240,000 liters when it becomes fully completed in the first half of next year (2023).

Upon the full completion of the plant, Samsung Biologics will have a total production capacity of 604,000 liters at its first campus in Incheon, South Korea. The company has acquired additional land for a second campus in the Songdo Industrial Cluster in Incheon, South Korea. which will house four biomanufacturing plants and an innovation center. Construction is set to begin later this year (2022). The second campus is 30% larger in size compared to the first campus.

Source: Samsung Biologics

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General

Thermo Fisher Opens Clinical Research Lab
Thermo Fisher Scientific has opened a 59,000-square-foot bioanalytical lab in Richmond, Virginia. The facility is part of a previously announced $97 million investment by the company to expand its bioanalytical laboratory operations in Richmond. The expansion will add more than 500 jobs over the next three years (as reported on October 12, 2022).

The current laboratory services operation in Richmond, which Thermo Fisher acquired through its $17.4-billion acquisition of the contract research organization, PPD, in December 2021, now comprises more than 350,000 square feet. The bulk of the expansion with this new facility will occur in liquid chromatography-mass spectrometry for drug discovery through to clinical testing, as well as subsequent enhancements in cell- and gene-therapy, biomarkers, vaccine sciences and immunochemistry.

Source: Thermo Fisher Scientific

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Cambrex Expanding Stability Storage Capacity
Cambrex has announced the expansion of its stability storage business, Q1 Scientific, which will open a new 20,000-square-foot cGMP facility in Liege, Belgium, and add an additional 10,000 square feet at its existing facility in Waterford, Ireland. The expansions are expected to be completed in the first half of 2023.

The Belgium facility will provide 35,000 temperature-controlled storage spaces for all key ICH climatic zones, support long-term, intermediate and accelerated stability trials, including for 2- 8 °C and 25 °C / 60% relative humidity (RH) and 40 °C / 75% RH.

Source: Cambrex

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Logistics4Pharma Expands Deep Freeze Storage Capabilities
Logistics4Pharma, a Frankfurt, Germany-based cold-chain packaging, storage, warehousing, and logistics company, is expanding its ultra-deep-freeze warehousing for temperatures as low as -80 °C to enable storage of protein-based medicines and vaccines. With the expansion, warehousing services offered by Logistics4Pharma now include a range of controlled temperatures from -80 °C to +25 °C.

Source: Logistics4Pharma