The latest from CDMOs, CMOs, and suppliers featuring National Resilience Inc., Center for Breakthrough Medicines, Recipharm, MilliporeSigma, Recro Pharma, Quotient Sciences, and Woodstock Sterile Solutions.

Chemicals/Chemical API Manufacturing

Quotient Sciences Integrates Drug Substance Capabilities.
Quotient Sciences, a Nottingham, UK-based CDMO, has integrated drug substance into its Translational Pharmaceutics platform. Quotient Sciences’ Translational Pharmaceutics approach combines manufacturing and clinical dosing at a single organization.

The newly integrated service unites drug-substance, drug-product and clinical-testing activities all within a unified organization and under a single project manager.

The full integration of drug substance R&D and manufacturing follows a year after the company’s acquisition of its Alnwick, UK site.

Source: Quotient Sciences

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Biologics Manufacturing

Recipharm Acquires Vibalogics; To Acquire Arranta Bio
Recipharm, a Stockholm, Sweden-based CDMO, has acquired Vibalogics, a CDMO of oncolytic viruses, viral vector vaccines, and viral vectors, and has agreed to acquire Arranta Bio, a CDMO of live biotherapeutic products and products of the human microbiome.

Vibalogics provides process and analytical development, manufacturing, testing and fill-finish services. The acquisition of Vibalogics provides Recipharm with capabilities in new biologics modalities.

Separately, Recipharm has agreed to acquire Arranta Bio, which provides Recipharm with a further platform to build its capabilities in new biologics modalities and establishes a US presence for Recipharm. Arranta Bio was founded in 201 by Mark Bamforth, founder and former CEO of Brammer Bio, a CDMO focusing on cell and gene therapies, which Thermo Fisher Scientific acquired for $1.7 billion in May 2019.

The acquisition is expected to be completed around the end of March 2022, subject to customary regulatory filings.

Source: Recipharm (Vibalogics) and Recipharm (Arranta Bio)

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Resilience Acquires R&D Lab, Gets $250-M US Gov’t Contract
Capri EGM, an investment company, has funded and acquired a newly constructed lab and R&D facility for National Resilience Inc, a CDMO of biologics and advanced therapies. The facility will be operated by Ology Bioservices, an Alachua, Florida-based subsidiary of Resilience and CDMO of biologics.

Earlier this month (February 2022), Ology Bioservices was awarded a contract, worth up to $250 million by the US Department of Defense (DoD) for manufacturing development of a monoclonal antibody as a medical countermeasure (MCM) to botulinum neurotoxins.

Under the contract, Resilience’s Ology site in Alachua, Florida, will advance the MCM to US Food and Drug Administration licensure and then will manufacture the drug at commercial scale and provide stock for military use.

Resilience’s site in Alachua is an Advanced Development Manufacturing facility of the DoD. It was established for the purpose of producing therapies and treatments to protect service members from biological weapons and natural threats.

Source: Resilience and Capri EGM

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CBM Adds Analytical Testing Labs for Cell, Gene Therapies
The Center for Breakthrough Medicines (CBM), a King of Prussia, Pennsylvania-based CDMO of cell and gene therapies, has opened analytical testing laboratories for cell- and gene therapies.

CBM’s Testing and Analytical Services business occupies approximately 200,000 square feet across four buildings along with a stand-alone safety testing laboratory on one campus.

In addition to analytical development capabilities, the campus has advanced analytics, including: (1) a dedicated Bioassay lab that supports potency assay development for early-stage development;  (2) a dedicated analytical lab to support assay development, full product, and process characterization, as well as release testing; (3) sequencing and molecular biology laboratories for full product characterization (4) testing platforms to support gene therapies, cell therapies, biologics, vaccines and plasmids; and (5) dedicated stability labs to support the International Council for Harmonization Q2 stability programs.

Source: Center for Breakthrough Medicines 

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Formulation Development/Drug-Product Manufacturing

MilliporeSigma Acquires Exelead; To Invest $567 M in Tech Scale-Up
Merck KGaA, the parent company of MilliporeSigma, the life-sciences arm of Merck KGaA, has completed its $780-million acquisition of Exelead, a bio/pharmaceutical CDMO that specializes in complex injectable formulations, including lipid nanoparticle (LNP)-based drug-delivery technology.

The business combination is expected to enable the MilliporeSigma to provide end-to-end CDMO services across the mRNA value chain. Merck KGaA plans to further invest over EUR 500 million ($567 million) to scale up Exelead’s technology over the next ten years (as reported on February 23, 2022).

Source: Merck KGaA

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Recro Updates Fill–Finish, Lyophilization Expansion 
Recro Pharma, a Gainesville, Georgia-based CDMO of oral solid drug products, has reported progress in adding fill-finish and lyophilization capabilities to its CDMO offerings.

All construction and equipment installation related to this service expansion has been completed at the company’s San Diego facility and final validation and commissioning activities are underway (as reported on February 23, 2022).

The company expects that a new automated fill-finish line and lyophilization unit will be operational early in the second quarter of 2022.

Source: Recro Pharma

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Recipharm Invests in New High-Speed Filling Line
Recipharm is investing to expand its sterile fill–finish production capabilities at its site in Monts, France.

The manufacturing facility, which specializes in the aseptic filling of pharmaceutical products, including biologics into vials and cartridges, currently has three lines for vials. The investment will expand Recipharm’s manufacturing footprint by adding a high-speed filling line that is able to fill 400 vials a minute, with the capacity for more than 100 million vials per year.

The new line will be fully commissioned in the second quarter of 2022 and is expected to be operational for commercial production in the third quarter of 2022. Recipharm says it is also in the process of implementing new cleanroom facilities and labs for microbiology and in-process controls.

The investment is part of a wider growth plan, which also sees Recipharm investing in new fill–finish facilities in India and Morocco. The additional sites will complement Recipharm’s existing sites in France, Germany, and Italy.

Source: Recipharm

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Woodstock Sterile Solutions To Expand Analytical Labs
Woodstock Sterile Solutions, a blow-fill-seal CDMO, is investing to expand its analytical lab space and enhance analytical capabilities at its facility in Woodstock, Illinois.

Within the expanded quality control lab, the company is making room to accommodate additional testing equipment and staff needed to perform method development work and ongoing product-release and stability testing. This expansion is targeted for completion in the first quarter of 2023.

Source: Woodstock Sterile Solutions