Supplier News: Lonza, Catalent, AGC Biologics & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring Lonza, Catalent, AGC Biologics, Cellipont Bioservices, ApiJect Systems, Societal CDMO, NJII, Schott, BD, and Gerresheimer. Highlights below.
* Lonza, Kodiak Sciences Open Bioconjugation Mfg Facility
* Catalent Launches New Mfg Platform for Gene Therapies
* AGC Biologics Adding Viral-Vector Mfg Capacity
* Avantor, Cytovance Biologics Partners To Provide Plasmid DNA
* New Jersey Innovation Institute Sells CDMO BioCentriq for $73 M
* Cellipont Bioservices To Expand Cell-Therapy Mfg Facility
Formulation Development/Drug-Product Manufacturing
* Catalent Investing $175 M To Expand Oral Dose Mfg Facility
* Injection Device Maker ApiJect Raises $111 M
* Societal CDMO Launches New Supply-Chain Risk Mitigation Service
* Schott Opens New Mfg Plant for Prefilled Syringes
* BD, Mitsubishi Gas Chemical in Pact for Prefilled Syringes
* Gerresheimer Expands Glass, Plastics Mfg in India
Lonza, Kodiak Sciences Open Bioconjugation Mfg Facility
Lonza and Kodiak Sciences, a Palo Alto, California-based bio/pharmaceutical company developing therapies treating retinal disease, have opened a new bioconjugation manufacturing facility within Lonza’s Ibex Dedicate BioPark manufacturing complex in Visp, Switzerland.
The facility will play a role in the scaled manufacturing of Kodiak’s lead therapeutic candidate, KSI-301, an anti-vascular endothelial growth factor (VEGF) biologic conjugated with a phosphorylcholine biopolymer, to support a potential global commercial launch. VEGF is a potent cytokine known to contribute to the pathology of retinal vascular diseases.
Once fully operational and if KSI-301 is approved for commercial use, the facility is expected to have the capacity to supply over 10 million dose equivalents of KSI-301 annually. Lonza will also use its global network of facilities, including Nansha, China, and Visp, Switzerland to produce Kodiak’s biopolymer, and Portsmouth, New Hampshire, to produce Kodiak’s monoclonal antibody.
Catalent Launches New Mfg Platform for Gene Therapies
Catalent has launched a new platform process for the development and cGMP manufacturing of adeno-associated viral (AAV) vectors.
The suspension-based UpTempo Virtuoso platform includes protocols for cell culture, transfection, and downstream purification, as well as a standardized bill of materials. The new platform is designed to provide a high-titer process that is capable of yielding drug product for clinical evaluation in nine months.
AGC Biologics Adding Viral-Vector Mfg Capacity
AGC Biologics, a contract biologics manufacturer, is adding viral-vector suspension technology and capacity for the development and manufacturing of gene therapies at its campus in Longmont, Colorado.
The viral-vector suspension expansion is a part of a more than $30-million investment by AGC Biologics in its new Longmont campus. The new suspension capabilities include a full complement of bioreactor sizes for product development (AMBR, 10 L and 50 L), and a range of commercial manufacturing capacities (50 L, 200 L, 500 L, and 2000 L).
This expansion more than doubles the site’s viral vector capacity and is expected to begin coming on line in the third quarter of 2022.
AGC Biologics acquired the Longmont campus in August of 2021. It had previously acquired a cell- and gene-therapy site in Milan, Italy, from MolMed S.p.A., a Milan-based bio/pharmaceutical company in 2020.
Source: AGC Biologics
Avantor, Cytovance Biologics’ Partners To Provide Plasmid DNA
Avantor, a provider of products and services to the life-sciences industries, and Cytovance Biologics, a biologics CDMO, have entered into an agreement to manufacture research and GMP-grade plasmid DNA, a process element in viral vector-based gene therapy and mRNA vaccines and therapeutics. This new relationship will allow Avantor to access plasmid DNA and other inputs used in research, clinical testing and manufacturing scale-up, and commercialization by using Cytovance Biologics’ plasmid cGMP manufacturing capabilities.
New Jersey Innovation Institute Sells CDMO BioCentriq for $73 M
New Jersey Innovation Institute (NJII), part of the New Jersey Institute of Technology (NJIT), has agreed to sell its subsidiary, BioCentriq, a Newark, New Jersey-based CDMO for cell- and gene-therapy process development and clinical manufacturing, to GC Corp., the holding company for GC Group in Yongin, South Korea with operating companies across healthcare sectors, for $73 million.
Founded in 2019 by the Biopharma Division of the NJII, BioCentriq manufactures autologous and allogeneic cell therapies and gene therapies and specializes in viral vector production, cell and viral banking, and upstream and downstream processing.
Cellipont Bioservices To Expand Cell-Therapy Mfg Facility
Cellipont Bioservices, a San Diego, California-based CDMO of cell therapies, plans to expand its cell-therapy development and manufacturing facility in Poway, California. The expansion will enable Cellipont to increase capacity for process development and Phase I/II programs.
The expansion includes additional warehousing, process development, quality control, and analytical development spaces. The new space is expected to be operational by the end of 2022. Cellipont plans a corresponding increase in hiring to staff the new facility.
Source: Cellipont Bioservices
Formulation Development/Drug-Product Manufacturing
Catalent Investing $175 M To Expand Oral Dose Mfg Facility
Catalent is investing $175 million to expand its US manufacturing facility for large scale-oral dose forms in Winchester, Kentucky. Two new buildings, expected to be completed by January 2024, will add 107,000 square feet to the site’s manufacturing footprint.
The expansion will broaden the site’s highly potent material-handling capabilities and containment vault, provide additional laboratory space, and add further capacity for existing operations, including dual fill encapsulation and pan coating alongside packaging and analytical services. When complete and fully operational, the expansion would add as many as 277 new jobs to the existing workforce of at the site now at 650.
Injection Device Maker ApiJect Raises $111 M
ApiJect Systems, a Stamford, Connecticut-based provider of prefilled syringes, has raised $111 million in private financing to continue development and deployment of its manufacturing platform for single-dose prefilled injection devices.
The latest round of investment was led by Royalty Pharma and Jefferies Financial Group, which acquired a revenue interest in addition to equity. The funds will be used for continued development of ApiJect’s blow–fill–seal plastic prefilled injection system, to deploy its equipment and technologies to licensees, and for general working capital purposes.
This investment round values ApiJect at approximately $300 million.
Societal CDMO Launches New Supply-Chain Risk Mitigation Service
Societal CDMO, the new name of Recro Pharma, a Gainesville, Georgia-based CDMO of drug products, has launched a new preparedness service for mitigating supply-chain risks and vulnerabilities.
Under the framework of a “20/80 Second Source Technical Transfer” service model, pharmaceutical companies are able to work with Societal CDMO to execute sourcing and planning phase activities of a technical transfer process prior to the time that product supply is needed. The company says by undertaking these activities in advance, customers can complete approximately half of the technical transfer process and position themselves to initiate the transfer of material and commence the batch manufacturing (execution phase) whenever new and/or additional finished drug-product supply is required to be “supply ready” approximately a full year sooner than if it commenced these activities at the onset of a supply disruption. The name of the service reflects that initial sourcing and planning phase activities account for 20% on average of the total technical transfer costs for a commercial product, whereas the execution/manufacturing phase makes up the remaining 80% of costs.
Source: Societal CDMO
Schott Opens New Mfg Plant for Prefilled Syringes
Schott, a specialty glass and materials company, has opened a new manufacturing facility for prefillable polymer syringes in Müllheim, Germany.
The investment in the three-digit million euro range includes a R&D center for prototyping of new polymer syringe solutions as well as a logistics and administrative area. The new site is designed to provide over 100 additional jobs in total.
BD, Mitsubishi Gas Chemical in Pact for Prefilled Syringes
Becton, Dickinson and Company (BD), a Franklin Lakes, New Jersey-based medical technology company, and Mitsubishi Gas Chemical Company (MGC), a Tokyo, Japan-based chemical manufacturer, have entered into an agreement for the development of technology for prefilled plastic syringes for biologic drug delivery.
MGC has developed the Oxycapt structure applied on silicon-free plastic syringe barrels to provide high breakage resistance, oxygen and vapor barrier, low protein adsorption, low extractables, UV barrier and pH stability. integrates the best of plastic and glass for plastic syringes
Source: Becton, Dickinson and Company
Gerresheimer Expands Glass, Plastics Mfg in India
Gerresheimer, specializing in glass and plastic packaging products for the pharmaceutical and healthcare industry, has expanded its glass and plastic production capacities in India.
The company has built a new plant for plastic containers and closures at its site in Kosamba, Gujarat, India, and added new furnace technology in its glass production in India.