Supplier News: Catalent, KBI Biopharma, GRAM & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring Catalent, Grand River Aseptic Manufacturing (GRAM), KBI Biopharma, Fujifilm Diosynth Biotechnologies, Lonza, Onyx Scientific, Genezen, and Amcor.
Biologics Drug Substance and Drug Product
Catalent Investing $350 M To Expand Biologics Drug Substance, Drug-Product Mfg
Catalent has announced a multi-year $350-million investment at its facility in Bloomington, Indiana, to expand biologics drug-substance and drug-product manufacturing.
The expansion includes the installation of new 2,000-liter single-use bioreactors and downstream processing for biologics drug substances to allow batches of up to 4,000-liters using single-use technology or 5,000-liters using existing stainless-steel bioreactors. Also included are quality control laboratories and additional packaging space with automated cartoning and auto-injector device assembly capabilities. This part of the expansion is expected to operational later this year (2022).
The site will also be adding to its drug product fill–finish capacity, with new syringe-filling lines under barrier isolator technology and additional lyophilized vial capacity. This expansion is expected to be completed in 2024.
These expansions are expected to add over 1,000 new jobs to Catalent’s Bloomington workforce in the coming years (as reported on April 21, 2022).
The announced investment follows recent investments in Catalent Biologics’ global network, including the modernization of its fill–finish and packaging facility in Limoges, France, and the acquisition of a new biologics development and manufacturing facility near Oxford, UK.
Chemicals/Chemical API Mfg
Onyx Scientific Expands Small-Molecule API Mfg
Onyx Scientific, a CDMO of small-molecule active pharmaceutical ingredients (APIs), has opened a second facility in Sunderland, UK.
The new site doubles the company’s current footprint and allows for expansion of chemistry, manufacturing and controls (CMC) activities and increases the company’s capacity for commercial API manufacturing by 50%. The first phase of the expansion is now complete and operational with GMP certification and commercial manufacturing approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). The final two phases of the expansion are expected to be completed by the end of 2022.
Source: Onyx Scientific
Catalent Acquires Cell Therapy Mfg Facility for $44.5 M
Catalent has acquired a commercial-scale cell-therapy manufacturing facility in Princeton, New Jersey from Erytech Pharma, a Cambridge, Massachusetts-based clinical-stage bio/pharmaceutical company, for $44.5 million.
The 30,900-square-foot facility houses 16 production suites as well as laboratories for analytical, quality control, and microbiology testing. The site will become a campus for development as well as clinical- and commercial-scale manufacturing of cell therapies. It will also work in collaboration with Catalent’s existing US clinical-scale cell-therapy manufacturing facility in Houston, Texas.
Concurrent with the acquisition, Catalent has agreed to terms to lease an adjacent 23,000-square-foot building that could be used for additional laboratory or cGMP services, and another building on the campus for potential future expansions. All staff at the site will transfer to Catalent’s employment, and Catalent is developing its plans for its future recruitment needs.
The deal includes a long-term supply agreement for Catalent to support Erytech’s lead product candidate, Graspa (eryaspase), a red blood cell-derived product, currently in late-stage development for treating acute lymphoblastic leukemia, under which Catalent will continue to manufacture eryaspase at the site. It will also support the development of Erytech’s pipeline of encapsulated red blood cell-based therapeutics for severe forms of cancer and orphan diseases.
KBI Biopharma Opens New $150-M Biomanufacturing Facility
KBI Biopharma, a Durham, North Carolina-headquartered biologics CDMO, has opened a new $150-million commercial biomanufacturing facility in Research Triangle Park, North Carolina.
Now fully operational, the 150,000-square-foot site employs more than 200 people in production, supply chain, engineering, quality control, and quality assurance positions. The company expects that number to grow to 350 by the end of the year (2022). KBI built this facility to support the manufacturing of mammalian-based products, starting with an undisclosed client’s late-phase clinical and commercial programs.
This is the second major facility expansion announced by KBI within the last two years. The company previously announced a new 5,600-square-meter biologic bulk drug substance manufacturing facility in Geneva, Switzerland. That facility is scheduled to be operational by mid-2022.
Source: KBI Biopharma
Fujifilm Diosynth Breaks Ground on BioProcess Center Expansion
Fujifilm Diosynth Biotechnologies, a biologics CDMO, has broken ground on the expansion of its BioProcess Innovation Center in Research Triangle Park, North Carolina.
The expansion will double the site’s existing laboratory footprint with an addition of 89,000 square feet that will have analytical instrumentation, bioprocessing equipment, and automation technologies through a collaboration with its sister Fujifilm company, Fujifilm Wako Chemicals USA.
The BioProcess Innovation Center originally opened in May 2016 as a three-story, 62,000-square-foot facility with the purpose of process invention, process design and development, and product characterization. The expansion construction is expected to be completed and the capacity operational by mid-2024. Through the expansion, Fujifilm Diosynth Biotechnologies will add approximately 145 positions, including researchers and scientists to the Research Triangle Park site by 2024.
Lonza Partners for Immunosafety Testing of Biologics
Lonza and Integral Molecular, a Philadelphia, Pennsylvania-based company, discovering and characterizing antibodies against membrane proteins, have announced a collaboration providing complementary expertise for in vitro immunosafety testing to assess off-target binding of biologic drug candidates.
Lonza’s Early Development Services focuses on cell-based assays to evaluate the activity of biologic therapies upon binding. Integral Molecular de-risks therapeutic molecules by detecting off-target binding liabilities using its Membrane Proteome Array platform.
Genezen Completes Construction of Viral Vector Mfg Facility
Genezen, a CDMO specializing in lentiviral and retroviral vector manufacturing, has completed construction of an early-phase clinical manufacturing facility in Indianapolis, Indiana. The expansion is part of an overall master plan for a 75,000-square-foot lentiviral and retroviral process development and cGMP vector production facility.
Genezen also announced the next phase of the expansion, which will include additional process development, analytical development, and quality control labs as well as cell banking and vector manufacturing suites with an expanded warehouse.
At the completion of the 75,000-square-foot facility, Genezen will increase delivery of lentiviral and retroviral vectors with adherent and suspension processes supporting both transient transfection and producer cell-line vector manufacturing platforms. Additionally, Genezen will expand host cell expansion and host cell banking.
The construction of Genezen’s expanded lentiviral and retroviral process development and analytical lab was completed in December 2021.
Formulation Development/Drug-Product Manufacturing
Grand River Aseptic Manufacturing in $160-M Expansion
Grand River Aseptic Manufacturing (GRAM), a CDMO of parenteral drug products, has announced a $160-million investment to fund the expansions of its fill–finish facilities in Grand Rivers, Michigan, which includes a $120-million multi-year contract with the US Department of Health and Human Services and the US Department of Defense.
The company currently has an 80,000 square-foot, large-scale filling facility and a 200,000 square-foot finishing center located in Grand Rapids. The pact supports the build-out of a second floor in its aseptic filling facility, along with a 30,000-square-foot expansion of its finishing center, including a sterility laboratory and added warehouse space. The agreement will increase GRAM’s filling capacity to a total of four isolator fill lines and further expands finishing operations.
This agreement stems from GRAM’s participation in Operation Warp Speed, the US government’s program for developing and manufacturing COVID-19 vaccines and therapeutics, where GRAM provided fill–finish services in the manufacturing of a COVID-19 vaccine.
Catalent Expands Nasal Drug Development, Mfg
Catalent has completed the first phase of an expansion of its facility in Morrisville, North Carolina, for nasal spray products. The newly completed first-phase expansion includes a micro vial filling line, automated inspection, and assembly line capable of supporting unit and bi-dose programs.
Amcor To Expand Sterile Packaging
Amcor, a Zurich, Switzerland-based packaging company, is adding new thermoforming capabilities for medical packaging at its facility in Sligo, Ireland. The multi-million-dollar expansion will feature Class 7 cleanroom manufacturing environments and thermoforming operations. Amcor will also create a design studio to support product development.