Quotient Sciences Acquires Arcinova; Recipharm Extends Mfg License
The latest from CDMOs, CMOs, and suppliers featuring Quotient Sciences, Recipharm, Catalent, RentschlerBiopharma, Vigene, TCG Lifesciences, and Argonaut Manufacturing Services.
Chemicals/Chemical API Manufacturing
TCG GreenChem Launches as a New CDMO
TCG Lifesciences, a contract research and manufacturing organization based in India, has expanded its operations in the US with the establishment of a subsidiary, TCG GreenChem, to provide CDMO services.
TCG GreenChem offers CMC development services, including process research and development, and delivery of active pharmaceutical ingredients (APIs) with expertise in automated catalysis/reaction screening, reaction optimization, and continuous chemistry.
TCG GreenChem is developing processes for select COVID-19 virus-related medicines and other antiviral drugs using new technologies and process schemes under contract with research foundations/hospitals, the US government, and select biotech companies.
TCG GreenChem operates out of a 3,000-square foot lab space in Virginia Commonwealth University’s Biotechnology Research Park in Richmond, Virginia. It also occupies 54,000 square foot pf lab/office space in the Princeton South Corporate Center, a process research and development facility in Ewing, New Jersey.
Source: TCG Lifesciences
Biologics Manufacturing
Rentschler Biopharma Expands into Cell and Gene Therapies
Rentschler Biopharma, a CDMO for biopharmaceuticals, is establishing its manufacturing capability in cell and gene therapy by establishing a Center of Excellence for cell and gene therapies in Stevenage, UK at the Cell and Gene Therapy Catapult (CGT Catapult), a center of excellence funded by Innovate UK, the UK government’s innovation agency,
With its newly formed UK subsidiary, Rentschler ATMP, Rentschler Biopharma will establish development and manufacturing capability in advanced therapy medicinal products (ATMPs), including adeno-associated virus vectors for clinical trial supply.
Over the next five years (as reported on February 11, 2021), Rentschler Biopharma says it plans to make a significant investment at the site to set up manufacturing of viral vectors for clinical supply and expects to be ready for cGMP manufacturing by the first half of 2022.
Source: Rentschler Biopharma (Center of Excellence) and Rentschler Biopharma (Investment Plan)
Vigene To Expand Cell and Gene Therapy Facility
Vigene Biosciences, a Rockville, Maryland-based CDMO specializing in viral vectors, has announced plans to expand into a new facility in Rockville, Maryland for its gene and cellular therapy products.
In addition to its existing headquarters, R&D, and manufacturing locations in Rockville, the company will lease 52,000 square feet of manufacturing space to bring the total lab and manufacturing space of the company to 110,000 square feet. Vigene will retain its current 125 employees and add up to 245 new jobs by the end of 2025.
Source: Vigene
Formulation Development/Drug-Product Manufacturing
Recipharm Extends Mfg License To Include Immunology Products
Recipharm, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has extended its manufacturing license to include immunology products, including vaccine products at clinical and commercial scales in both freeze-dried and liquid forms.
The license, which applies to its facility in Wasserburg, Germany, also covers microbiological testing to allow Recipharm to insource bacterial endotoxin testing on its products, including testing diluent for one of the COVID-19 vaccines.
The new accreditation includes key biologic analytical techniques, including gel electrophoresis, UV/VIS spectrophotometers, and osmometers, with plans to add more in 2021. In addition, the facility has also bolstered it packaging capabilities to support customers with clinical trial packaging.
Source: Recipharm
Catalent Launches Dual Chamber Capsule for Health Topical Applications
Catalent has launched new dual-chamber softgel capsule technology for the delivery of topical skin treatments.
The CosmoPod Duo capsule features segregated compartments to accommodate two formulations into a single twist-off capsule. The new dosing format allows for the following applications: the simultaneous application of treatments that combine hero ingredients typically not compatible together; that have a shorter shelf life when combined; or two complementary hero ingredients. The capsule is hermetically sealed to help protect formulations from light and oxidation and to improve stability compared to traditional beauty applications
Source: Catalent
Quotient Sciences Acquires UK-Based CDMO Arcinova
Quotient Sciences, a Nottingham, UK-based CDMO, has acquired Arcinova, an Alnwick, UK-based multiservice CDMO.
Arcinova has 160 employees and provides drug-substance, drug-product, and bioanalysis services. As part of the deal, Arcinova’s minority equity partner, BGF, will exit the business, having backed its growth since 2018.
Source: Quotient Sciences and Arcinova
General
Argonaut Opens Custom Controls and Standards Facility
Argonaut Manufacturing Services, a Carlsbad, California-based CDMO, has launched a new service offering for controls, standards and verification panels.
The Custom Molecular Controls and Standards are for use for diagnostics and research use only The service of formulating and filling products will be performed at a newly commissioned, stand-alone facility in Carlsbad, California.
Source: Argonaut Manufacturing Services
