Supplier News: Thermo Fisher, Catalent, MilliporeSigma & More
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The latest from CDMOs, CMOs, and suppliers featuring Thermo Fisher, Fujifilm Diosynth, Catalent, MilliporeSigma, Piramal Pharma Solutions, Curia, Univercells, Continuus Pharmaceuticals, NovAliX, and Dipharma.

Chemicals/Chemical API Manufacturing

Continuus To Build $125-M Continuous Mfg Facility
Continuus Pharmaceuticals, a spin-out company founded by scientists involved in a collaboration between the Massachusetts Institute of Technology and Novartis in continuous manufacturing, has signed a contract with Skanska, a construction- and project-development company, to build a continuous pharmaceutical manufacturing facility in Woburn, Massachusetts.

The project includes the renovation and building of a new 50,000-square-foot manufacturing facility in an existing shell space. The new facility will produce both dry active pharmaceutical ingredients and finished drug products in both sterile injectable and tablet forms. The facility is being developed to produce three critical care medicines and one additional drug with flexibility for future growth. 

Construction activities for the project began in October 2021 and are scheduled for completion in the second quarter of 2022.

Source: Continuus Pharmaceuticals


CRO Kalexsyn Merges into Dipharma
Kalexsyn, a Kalamazoo, Michigan-headquartered CRO providing chemistry services to the bio/pharmaceutical industry, has been merged into its 100% owner, Dipharma, a CDMO of active pharmaceutical ingredients, effective January 1, 2022.

The merger represents the last step of Kalexsyn’s integration into the Dipharma Group, which started in May 2018 with the acquisition of the company. The acquisition was part of Dipharma’s decision to advance in the CDMO market and increase its presence in the US.

Source: Dipharma


Biologics Manufacturing

Thermo Fisher Acquires PeproTech for $1.85 Bn
Thermo Fisher Scientific has completed its acquisition of PeproTech, a Cranbury, New Jersey-based developer and manufacturer of bioscience reagents and other products, such as cytokines and growth factors, for approximately $1.85 billion.

PeproTech’s recombinant proteins portfolio complements Thermo Fisher’s cell-culture media products. PeproTech will become part of the biosciences business within Thermo Fisher and will be integrated into Thermo Fisher’s Life Sciences Solutions Segment.

Source: Thermo Fisher Scientific


Fujifilm Diosynth Expands BioProcess Innovation Center
Fujifilm Diosynth Biotechnologies, a biologics CDMO and subsidiary of Fujifilm Corporation, has expanded its BioProcess Innovation Center in Research Triangle Park, North Carolina.

Through the expansion, Fujifilm Diosynth Biotechnologies will add approximately 145 skilled positions, including researchers and scientists to the Research Triangle Park site by 2024. The expansion will double the company’s capacity to support process characterization programs and complements Fujifilm Diosynth Biotechnologies’ UK facility.

Source: Fujifilm Diosynth Biotechnologies


Piramal Takes Minority Stake in CDMO Yapan Bio
Piramal Pharma Limited (PPL), the pharmaceutical business of Piramal Enterprise Limited, is investing INR101.77 ($13.7 million) in Yapan Bio, a Hyderabad, India-based CDMO, to augment its CDMO business, Piramal Pharma Solutions. PPL holds a 27.78% equity stake in the company as a result of this investment.

Yapan Bio provides process development, scale-up, and manufacturing of vaccines and biologics/biotherapeutics, including high-containment product classes (up to BSL-2+), recombinant vaccines, RNA/DNA vaccines, gene therapies, monoclonal antibodies, therapeutic proteins, and other complex biologics.

Source: Piramal Pharma Solutions


Univercells Acquires SynHelix
Univercells, a technology company specializing in bioprocessing, has acquired SynHelix, an Evry-Courcouronnes, France-based biotechnology company, to enter synthetic biology and DNA synthesis. SynHelix has a technology that is an alternative to DNA amplification on bacteria.

Following the transaction, SynHelix will become Quantoom Research Center, a separate legal entity and new affiliate of the Univercells Group, established in France. Both the founders of SynHelix and AdBio partners, a French life-sciences venture capital firm, will become minority shareholders of Univercells. SynHelix plans to transfer this technology to the Quantoom’s automated platform, integrating a new gDNA bioreactor both for R&D and production needs.

Source: Univercells


Formulation Development/Drug-Product Manufacturing

MilliporeSigma To Acquire CDMO Exelead for $780 M
Merck KGaA, the parent company of MilliporeSigma, has agreed to acquire Exelead, a bio/pharmaceutical CDMO that specializes in complex injectable formulations, including lipid nanoparticle (LNP)-based drug-delivery technology, for approximately $780 million.

Exelead has more than ten years of experience in all development phases from pre-clinical development to commercial contract manufacturing for LNP formulations, including fill– finish. Exelead is headquartered in Indianapolis, Indiana where it operates its production and employs more than 200 people. Merck KGaA says it intends to continue to invest in mRNA as a modality and will scale up this technology at Exelead’s existing site in Indianapolis.

The transaction is expected to close in the first quarter of 2022 and is subject to regulatory clearances as well as the satisfaction of other customary closing conditions. 

Source: Merck KGaA


Curia Launches New mRNA Services
Curia (formerly AMRI) has unveiled its messenger RNA (mRNA) service, which includes discovery, process development, mRNA drug-substance production, large-scale lipid manufacturing, lipid nanoparticle (LNP) formulation, and development for full-scale sterile fil–finish services.

Curia’s mRNA service is designed to streamline the development and delivery of mRNA-based products, which span various therapeutic areas including cancer, heart disease and chronic illnesses in addition to its current application in vaccines.

Source: Curia


General

Catalent Names New CEO and President
Catalent has appointed Alessandro Maselli, currently President and Chief Operating Officer, as the company’s next President and Chief Executive Officer, effective July 1, 2022. Mr. Maselli will also join the company’s Board of Directors upon assuming his new role. Current Chair and CEO John Chiminski will remain in his present role until July 1, 2022, when he will assume the position of Executive Chair of the Board.

Source: Catalent


MilliporeSigma Gets $136.7-M for Lateral-Flow Mfg Facility
MilliporeSigma, the life sciences arm of Merck KGaA, has been awarded a $136.7-million contract from the US government for the construction of a lateral flow membrane production facility over a three-year period at the company’s Sheboygan, Wisconsin site.

The contract from the US Department of Defense on behalf of the US Department of Health and Human Services, is part of an effort to ensure secure local supply and production capacity for critical products for pandemic preparedness. 

Hi-Flow Plus Lateral flow membrane is used in rapid diagnostic test kit manufacturing. The rapid test kits are used for a variety of applications, including infectious-disease testing (COVID-19, HIV, influenza, malaria, etc.), as well as in women’s health, biomarker detection, drug testing, food safety and animal health. 

Source: MilliporeSigma


Piramal Expands In-Vitro Biology Site
Piramal Pharma Solutions, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has made a multi-million-dollar investment to create a high-throughput screening facility that will augment existing in-vitro biology capabilities at its drug-discovery services site in Ahmedabad, India. This new expansion, which is expected to go live in the third quarter of 2022, will add to the primary and secondary screening capabilities of compounds prepared at the Ahmedabad site.

Source: Piramal Pharma Solutions


Syngene, Amgen Expand R&D Pact
Syngene International, a Biocon subsidiary and Bangalore, India-headquartered CRO, and Amgen have expanded their multi-discipline research collaboration.

The contract is currently extended until the end of 2026 and its scope includes integrated drug discovery and development solutions in discovery chemistry and biology, peptide chemistry, antibody and protein reagents, pharmacokinetics and drug metabolism, and pharmaceutical development. In addition to operating the existing Syngene Amgen R&D Center, under the new contract, Syngene will also build and operate a dedicated laboratory which will enable R&D project acceleration.

Source: Syngene


CRO NovAliX Acquires Sanofi Site for Research Campus
NovAliX, a contract research organization (CRO) specializing in drug research and development, has acquired a 3.7-acre site from Sanofi to create a pharmaceutical research campus, according to an announcement from Andrew Lloyd & Associates, a public relations consultancy firm for NovAliX. 

The site, known as the Guy Ourisson Research Campus, includes a 8,000-m2 building designed for pharmaceutical research. The construction program will commence in 2022 and transform the site at the campus.

Source: Andrew Lloyd & Associates