Supplier News: Catalent, Kindeva, Quotient, Hovione & More
The latest from CDMOs, CMOs, and suppliers featuring Catalent, Kindeva Drug Delivery, Meridian Medical Technologies, Hovione, Quotient Sciences, Goodwin Biotechnologies, Phlow, Evonik, and AGC Biologics.
Chemicals/Chemical API Manufacturing
* Quotient Sciences Opens Drug-Substance Mfg Facility
* Phlow, USP Open R&D Labs for Advanced Mfg
Biologics Manufacturing
* Catalent Investing $40 M To Expand Biologics Testing
* Goodwin Biotechnologies Rebrands as GBI
* AGC Biologics, Gore Collaborate in Downstream Processing
Formulation Development/Drug Product Manufacturing
* Kindeva, Meridian Complete Merger
* Hovione, GEA in Pact for Continuous Tableting
* Evonik Launches Plant-Based Squalene
Chemicals/Chemical API Manufacturing
Quotient Sciences Opens Drug-Substance Mfg Facility
Quotient Sciences, a Nottingham, UK-based CDMO of drug substances and drug products, has opened a new drug-substance manufacturing facility in Alnwick, Northumberland, UK.
Quotient Sciences completed the £6 million ($7.5 million) building expansion in October 2022. The newly expanded space features multi-purpose capacity of up to 15 GMP reactor streams with reactor volumes ranging from 5 liters up to 150 liters and deployment of both batch and continuous flow chemistry technologies.
The completion of this facility will create an additional 80-100 new scientific and technical jobs at the Alnwick site, which currently employs 200 people across a range of scientific disciplines, including process chemistry, solid-state characterization, radiosynthesis, bioanalysis, and formulation development.
Source: Quotient Sciences
Phlow, USP Open R&D Labs for Advanced Mfg
Phlow, a US-based public benefit company and CDMO, and the US Pharmacopeia (USP), a non-profit scientific and standards-setting organization, have opened laboratories at the Advanced Pharmaceutical Development Center in Richmond, Virginia, to provide bio/pharmaceutical companies and the US government R&D services for small-molecule active pharmaceutical ingredients (APIs) and key starting materials that use advanced manufacturing technologies, including continuous manufacturing.
The collaboration will facilitate the development of guidelines, best practices and resources to assist in the adoption of advanced manufacturing technologies. Using in-house scientific expertise and facilities, including the Richmond facility and USP’s facility in Rockville, Maryland, USP and Phlow will offer R&D analytical services that include, though are not limited to, drug assays, methods to control impurities, cleaning validation, purity analysis, material isolation, identification and characterization, spectrometric and other process analytical technology applications.
In addition to its new R&D lab, Phlow is also in the process of further growing its advanced manufacturing infrastructure. It is on track to open cGMP API manufacturing facilities in Petersburg, Virginia, in 2023 and 2024 to move programs into an advanced manufacturing environment. The facilities will provide a platform for accelerating the transfer of processes developed in the lab into medium and large-scale reactors to support early-to-late stage clinical and commercial production.
Biologics Manufacturing
Catalent Investing $40 M To Expand Biologics Testing
Catalent is investing $40 million for a new Biologics Analytical Center of Excellence in Durham, North Carolina, to provide stand-alone analytical development and testing for biologic drug modalities, including cell and gene therapies.
Catalent plans to fit out the 80,000 square-foot facility with equipment and instrumentation, including automation and digitization capabilities. The center will provide services for bioassays, physico-chemical testing, product and process characterization, process validation support, stability testing, in-process manufacturing, formulation analysis, and post-packaging identification.
Catalent expects to complete the facility by mid-2023, which will support the hiring of over 200 scientists and technicians over the next five years (as reported on December 14, 2022).
Source: Catalent
Goodwin Biotechnologies Rebrands as GBI
Goodwin Biotechnologies, a Plantation, Florida-based CDMO of biologics, has rebranded as GBI and has announced details of an upcoming facility expansion.
GBI’s Florida manufacturing and process development facility will be expanded by 5,000 square feet and will feature 200-L, 500-L and 2,000-L bioreactors, fill–finish hand-filling up to 2,000 vials, and automated fill–finish up to 10,000 vials. The expansion will be finished by the second quarter of 2023.
Source: GBI (Rebrand) and GBI (Facility info)
AGC Biologics, Gore Collaborate in Downstream Processing
AGC Biologics, a Seattle, Washington-based CDMO of biologics, and W.L. Gore & Associates, a Newark, Delaware-based science material company, have entered a collaboration that features Protein A affinity purification technology from Gore and AGC’s CDMO services.
The collaboration includes the family of Gore protein-capture devices with Protein A, which improves productivity in Protein A affinity purification and provides high-binding capacity at short residence times, alongside AGC Biologics’ monoclonal antibody-based CDMO services. The joint offering from Gore and AGC Biologics is available across various sites in AGC Biologics’ network.
Source: AGC Biologics
Formulation Development/Drug Product Manufacturing
Kindeva, Meridian Complete Merger
Kindeva Drug Delivery (formerly 3M Drug Delivery Systems), a CDMO of drug-delivery services, and Meridian Medical Technologies, a Saint Louis, Michigan-based CDMO of autoinjectors, have completed the merging of the two companies.
The combined company, now of drug–device CDMO, will operate under the Kindeva name, with Meridian operating as “Meridian Medical Technologies, a Kindeva company”. The combined company has a range of drug-delivery capabilities for parenteral, inhalation, transdermal, and intradermal routes of administration. Milton Boyer, current CEO of Meridian, will be CEO of the newly combined company.
Kindeva and Meridian are both operating companies of Altaris, a healthcare investment firm. Kindeva was acquired by Altaris in 2020 from 3M Company, and Meridian was acquired by Altaris in December 2021 from Pfizer.
Source: Kindeva Drug Delivery
Hovione, GEA in Pact for Continuous Tableting
Hovione, a CDMO of drug substances and drug products, and GEA, a provider of pharmaceutical manufacturing equipment and process technology services, have formed a collaboration to advance continuous tableting. The partnership combines GEA´s engineering expertise with Hovione´s development and manufacturing experience advanced the adoption of continuous tableting technology.
Source: Hovione
Evonik Launches Plant-Based Adjuvant
Evonik, an excipient and specialty/fine chemicals manufacturer, has launched a non-animal-derived squalene, PhytoSquene, an amaranth oil-derived squalene for use in adjuvants in parenteral dosage forms and vaccines. It is an alternative to animal-derived squalene, which for pharmaceutical applications is typically sourced from shark liver oil. Non-GMP samples of PhytoSquene are available with GMP quality to follow in 2023.
Source: Evonik
