Supplier News: Olon, Thermo Fisher, Delpharm & More
The latest from CDMOs, CMOs, and suppliers featuring Olon, Thermo Fisher Scientific, Catalent, MilliporeSigma, Delpharm, uBriGene, GenScript Biotech, Aurigene, TriLink, Touchlight, JSR Life Sciences, KBI Biopharm, Selexis, eureKING, Resilience, AmbioPharm and VectorBuilder.
Chemicals/Chemical API Manufacturing
* Olon Investing in New ADC Mfg Facility
* GenScript Expands Peptide & Oligonucleotide Mfg Facility
* AmbioPharm Adds Equipment for Peptide Mfg
* SPAC eureKING Proposes To Acquire CDMO Skyepharma
* MilliporeSigma Investing $37 M in Biosafety Testing Facilities
* Catalent Adds Cryogenic Capabilities at Japan Site for Cell & Gene Therapies
* Cell-& Gene-Therapy CDMO uBriGene Acquires Mfg Facility
* Aurigene Pharma Investing $40 M for New Pilot Biomanufacturing Facility
* JSR Life Sciences Consolidates KBI BioPharma and Selexis
* Resilience, LabCorp Partner To Expand Cell- & Gene-Therapy Offerings
* TriLink Expanding mRNA Mfg Facility
* Touchlight Expands Plasmid DNA Mfg Facility
* VectorBuilder Opens Office in Edinburgh
Formulation Development/Drug Product Manufacturing
* Thermo Fisher Opens Sterile Drug Mfg Plant in Singapore
* Astellas To Divest Drug-Product Mfg Plant to Delpharm
* Real Estate Investment Firm Nexpoint Acquires Two Properties from CDMO Adare Pharma Solutions
Chemicals/Chemical API Manufacturing
Olon Starts Construction of a New ADC Mfg Facility
Olon, a CDMO of active pharmaceutical ingredients (APIs) and intermediates, has started the construction of a new facility at its site in Rodano, Milan, Italy, which will be dedicated to managing and producing ultra-potent compounds used as payloads and payload-linkers for antibody-drug conjugates (ADCs).
Olon is investing EUR 22 million ($23.5 million) in the new facility. Upon constrction of the new building, a second shell will be built containing the production facility and the quality control and research and development areas as well as all auxiliary facilities. This complete, closed-loop system will include all steps of the process: synthesis, isolation, drying and analysis, and the ultra-high-containment plant.
The first phase of the construction, to build the payload research and development area, has begun and is expected to be completed by the first half of 2024. Once completed, the company will move on to the second stage of finalizing the production line by creating the quality control and GMP production areas, with the installation of industrial production equipment.
In a separate development, Olon has added a mill for grinding finished APIs at its site in Mulazzano, Lodi, Italy, as part of its EUR 100 million ($108 million) expansion plan in API manufacturing.
GenScript Expands Peptide & Oligonucleotide Mfg Facility
GenScript Biotech, a Piscataway, New Jersey-based CDMO, has expanded its primary manufacturing facility for oligonucleotide and peptide production in Zhenjiang, Jiangsu Province, China.
The new building spans 91,310 square feet, and four new dynamic axial compression columns have been added to support large-scale peptide production with average monthly production capacity of more than 5 kg, with 32 square feet of freeze dryers for the mass freeze-drying process. The newly expanded production lines enable the production of up to 30,000 peptides per month and kilogram-level batch production.
Source: GenScript Biotech
AmbioPharm Adds Equipment for Peptide Mfg
AmbioPharm, a North Augusta, South Carolina-based CDMO of peptides, has added new equipment.
For late-phase and commercial production, the company made installations that include: (1) a high-performance liquid chromatography column; (2) a 1,000-L lyophilizer; (3) a tangential flow filtration system with centrifuge; (4) a large walk-in 2-8 degree Celsius stability chamber; and (5) a -20 degree Celsius walk-in freezer. The company also added equipment to support green manufacturing.
SPAC eureKING Proposes To Acquire CDMO Skyepharma
eureKING, a Paris-based special purpose acquisition company (SPAC) focused on bioproduction, has submitted an offer to acquire Skyepharma, a Saint-Quentin-Fallavier, France-based CDMO of oral drug technologies.
eureKING was founded in March 2022 by eureKARE, an investment firm focused on financing and building companies in the fields of synthetic biology and the microbiome. eureKING’s plan is to invest in biologics CDMOs in three main areas: (1) the production of biologics, in particular new generations of monoclonal antibodies or complex proteins; (2) the production of cell and gene therapies; and (3) the production of live biotherapeutics (with applications in the microbiome).
Skyepharma has what it calls its “Skyehub” model that hosts dedicated biomanufacturing facilities to allow customers to use the company’s quality system and, at the same time, preserve intellectual property. The Skyehub model has an initial focus on live biotherapeutic products. eureKING said that Skyepharma’s scalable and manufacturing platform would facilitate eureKING’s strategy to combine companies specializing in the production of biological products, cell and gene therapies, and live biotherapeutics.
MilliporeSigma Investing $37 M in Biosafety Testing Facilities
MilliporeSigma, the life science business of Merck KGaA, is investing EUR 35 million ($37 million) in expanding biosafety testing at its Glasgow and Stirling sites in Scotland.
The investment includes a 1,200-square-meter facility in Glasgow, which will house molecular biology and sequencing services. The company will expand testing capacity in its current buildings with biosafety testing, analytical development, and viral clearance suites. The expansion will create nearly 500 new jobs, bringing the company’s workforce to over 1,200 employees across the two sites.
Catalent Adds Cryogenic Capabilities at Japan Site for Cell- & Gene-Therapies
Catalent has expanded the services and capabilities of its facility in Shiga, Japan, to include the storage, kitting, and distribution of cell- and gene-therapies at ultra-low temperatures for clinical trials.
Cryogenic freezers, alongside material-transfer equipment, have been installed that are designed to maintain investigational cell- and gene-therapies by minimizing their time-out-of-environment. The expansion follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in ultra-low temperature storage capabilities.
Cell-& Gene-Therapy CDMO uBriGene Acquires Mfg Facility
uBriGene, a Vancouver, British Columbia, Canada-based cell- and gene-therapy CDMO, has acquired a GMP manufacturing facility from Mustang Bio, a Worcester, Massachusetts-based bio/pharmaceutical company.
The 27,000-square-foot site is designed for multiproduct cGMP manufacturing of multiple gene-modified cell types and has integrated capabilities for technology transfer, quality control testing, manufacturing development, warehousing, and cGMP storage.
uBriGene has two GMP manufacturing facilities in China and its headquarters site in Vancouver, Canada. The new facility will expand uBriGene’s global headcount to over 500 employees.
Aurigene Pharma Investing $40 M for New Biomanufacturing Pilot Mfg Facility
Aurigene Pharmaceutical Services, a Hyderabad, India-based CDMO and a subsidiary of Dr. Reddy’s Laboratories, is investing $40 million for the construction of a R&D and pilot-scale biomanufacturing facility. The facility is designed as a multi-product, multi-platform facility for therapeutic proteins, antibodies, and viral vectors. The facility is planned to be fully operational in the first half of 2024.
Source: Aurigene Pharmaceutical Services
TriLink Expanding mRNA Mfg Facility
TriLink BioTechnologies, a San Diego, California-based CDMO, is expanding its mRNA manufacturing capabilities with the construction of a new 32,000-square-foot, cGMP-grade facility for mRNA manufacturing.
The building has been designed for the cGMP manufacture of mRNA-based in vivo gene editing, gene-edited cell therapies, protein-replacement therapies, cancer vaccines, and infectious disease vaccines. The facility is expected to be operational in early 2024.
Source: TriLink BioTechnologies
Touchlight Expands Plasmid DNA Mfg Facility
Touchlight, a Hampton, UK-based CDMO of cell- and gene-therapies, has completed the redevelopment and expansion of its UK plasmid DNA manufacturing facility.
The facility’s manufacturing capacity has tripled and is now capable of producing more than 8 kg a year. The facility has 11 suites and includes two Class B filling suites with Class A filling cabinets, warehousing, and a quality control laboratory.
The expansion follows the US Food and Drug Administration’s acceptance in December 2022 of a drug master file and first investigational new drug application using doggybone DNA, Touchlight’s proprietary technology for producing plasmid DNA.
JSR Life Sciences Consolidates KBI Biopharma and Selexis
JSR Life Sciences, a Sunnyvale, California-based provider of drug-discovery and development services and products for bio/pharmaceuticals, has announced that its subsidiaries, KBI Biopharma, a Durham, North Carolina-based biologics CDMO, and Selexis, a Plan-les-Ouates, Switzerland-based provider of cell-line development services, are consolidating as one organization under the KBI Biopharma name.
Source: JSR Life Sciences
Resilience, LabCorp Partner To Expand Cell- & Gene-Therapy Offerings
Resilience, a San Diego, California-based CDMO of biologics, has entered a strategic collaboration with LabCorp to establish a joint customer service offering that provides end-to-end capabilities for the preclinical development, clinical development, and commercial manufacturing of cell and gene therapies.
Labcorp will focus on preclinical and clinical development, laboratory, and commercialization services. Resilience will focus on manufacturing process development, process technology scale-up/out and technology transfer and GMP manufacturing.
VectorBuilder Opens Office in Edinburgh
VectorBuilder, a Chicago, Illinois-based CDMO of biologics, has opened a new office in Edinburgh, UK.
Formulation Development/Drug Product Manufacturing
Thermo Fisher Opens Sterile Drug Mfg Plant in Singapore
Thermo Fisher Scientific has opened a new sterile drug facility in Singapore. The cGMP facility will provide vaccine fill-finish capabilities along with end-to-end pharmaceutical development and manufacturing services. The facility was built with assistance from the Singapore Economic Development Board in alignment with the government’s investment in preparedness for future health emergencies.
Source: Thermo Fisher Scientific
Astellas To Divest Drug-Product Mfg Plant to Delpharm
Astellas plans to to transfer its manufacturing plant and business based in Meppel, the Netherlands, to Delpharm, a CDMO of drug products. The manufacturing plant produces solid-dosage forms and employs 332 personnel.
With this site, Delpharm will add to its position in the Netherlands, where the CDMO already owns one manufacturing site in Bladel and an injectable drug development center in Leiden.
The agreement will be executed after completing works council consultation and local legal and regulatory requirements.
Real Estate Investment Firm NexPoint Acquires Two Properties from CDMO Adare Pharma Solutions
NexPoint, a real estate investment firm, has acquired two life-sciences industrial properties from Frontida Biopharm, a Philadelphia, Pennsylvania-headquartered CDMO focused on oral drug formulations and a subsidiary of Adare Pharma Solutions, a CDMO and provider of pharmaceutical technologies.
The real estate acquisition includes nearly 18 acres of land across the two separate properties and more than 250,000 square feet of interior space where Frontida Biopharm will remain the tenant. The first property comprises R&D, production, and warehouse facilities capable of producing three billion tablets and capsules annually. The second property features distribution facilities and packaging capacity for four billion tablets and capsules annually.
The properties were indirectly acquired by NexPoint Life Sciences II DST, a Delaware statutory trust seeking to raise $42 million in equity from accredited investors via a private placement offering.