Supplier News: CordenPharma, Flamma, Upperton & More
The latest from CDMOs, CMOs, and suppliers featuring CordenPharma, Flamma, BioDuro, Cenra, Bora Pharmaceuticals, Upperton, Biologos, Coating Place and more.
Chemicals/Chemical API Manufacturing
* CordenPharma in Peptide Lab Expansion
* Flamma API Mfg Site Passes FDA Inspection
* BioDuro, Cenra API Form JV for API Mfg
Formulation Development/Drug Product Manufacturing
* Bora Pharmaceuticals, GSK in $250-M Mfg Pact
* Upperton Submits Application for Sterile Mfg Facility Approval
Appointments
* Biologos Appoints New CEO
* Coating Place Appoints New VPs
General
* LabVantage Launches AI Platform
Chemicals/Chemical API Manufacturing
CordenPharma, BioMed In Peptide Lab Expansion Pact
CordenPharma has leased 64,000 square feet for a peptide-development lab at BioMed Realty’s Flatiron Park, a campus supporting life science, quantum and technology tenants in Boulder, Colorado, near the company’s existing CordenPharma Colorado facility.
CordenPharma Colorado will be the sole tenant at Flatiron Park 5505 Central, a newly completed, purpose-built peptide development lab. CordenPharma has signed a 15-year lease for the building. The new LEED Gold-certified facility is adjacent to CordenPharma Colorado’s large-scale peptide manufacturing facility. The space will house process development and analytical services to enable integration of advanced peptide active pharmaceutical ingredient production from development through commercialization.
Source: CordenPharma
Flamma API Mfg Site Passes FDA Inspection
The Flamma Group, a CDMO of small-molecule active pharmaceutical ingredients (APIs) and late-stage intermediates, reports its Flamma USA site, located in Malvern, Pennsylvania, has successfully passed its first US Food and Drug Administration (FDA) inspection.
The pre-approval inspection took place over the course of four days for an API that the Flamma USA site will manufacture for a global pharmaceutical company. The inspection covered the entire facility, including the manufacturing equipment and quality system, and the site was found to be compliant with all FDA GMP requirements.
The Malvern site was acquired by Flamma in late 2019. Since the acquisition, the site has seen investments of over $3 million. The site is focused on early-stage small-molecule drug development and manufacture of APIs, including for small-volume, orphan, and niche indication APIs.
Source: Flamma
BioDuro, Cenra API Form JV for API Mfg
BioDuro, an Irvine, California-based CDMO, has established a joint venture with Cenra API Solutions, also as known as Chunghwa Chemical Synthesis & Biotech Co., a pharmaceutical chemical manufacturer in Taiwan, to add commercial-scale active pharmaceutical ingredient (API) manufacturing capacity at Cenra’s campus in Taipei, Taiwan, to BioDuro’s global network.
The joint venture will integrate BioDuro’s capabilities in early-stage drug development with Cenra’s expertise in commercial-scale GMP API manufacturing to provide an end-to-end API solution from early development through to commercial-scale manufacturing.
Cenra’s Taipei campus houses 10 GMP API production lines with a total reactor volume of more than 350,000 liters to support annual API output of up to 200 metric tons. The facility has been successfully inspected by several major international regulatory agencies, including the US Food and Drug Administration, the European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency, and the Taiwan Food and Drug Administration.
Source: BioDuro
Formulation Development/Drug Product Manufacturing
Bora Pharmaceuticals, GSK in $250-M Mfg Pact
Bora Pharmaceuticals and GSK have signed a strategic agreement to renew a $250-million five-year manufacturing partnership.
Bora manufactures more than 20 commercial products for GSK at its Mississauga, Ontario, Canada, site, which Bora purchased from GSK in 2020. This renewed collaboration reinforces the long-standing relationship between the two companies and expands the partnership, allowing GSK access to multiple sites within the Bora network, including its newest oral solid dose site in Maple Grove, Minnesota.
Source: Bora Pharmaceuticals
Upperton Submits Application for Sterile Mfg Facility Approval
Upperton, a Nottingham, UK-based CDMO of drug products, has formally submitted its application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for approval of its 7,000-square-foot sterile manufacturing facility. The submission follows the successful completion of aseptic process simulation validation batches executed under the revised EU GMP Annex 1 (2023) requirements.
The facility is in addition to the company’s existing 50,000-square-foot development and manufacturing facility in Nottingham, UK, and will support the formulation development and manufacturing of aseptic and terminally sterilized drug products for parenteral, nasal, and pulmonary drug delivery. The facility supports small and medium-sized biotech and pharmaceutical companies from preclinical to Phase I and Phase II clinical studies with formulation development, clinical manufacture, and analytical testing, with initial batch sizes up to 2,000 units.
Source: Upperton
Appointments
Biologos Appoints New CEO
Biologos, a manufacturer of custom cell-culture media, buffers and reagents, has announced the appointment of Hetal Patel, currently Chief Operating Officer at Biologos, as Chief Executive Officer. Patel brings more than 25 years of experience driving commercial growth, operational excellence, and organizational transformation across regulated life-sciences environments. She joined Biologos in 2024 as Chief Operating Officer.
Source: Biologos
Coating Place Appoints New VPs
Coating Place, a CDMO of microencapsulation services, has appointed Cara Young, currently Executive Director, Business Development at Bend Bioscience, as Vice President of Business Development, and Jeffrey Peterson, currently Vice President of Finance at Sigma Engineered Solutions, as Vice President of Finance.
Young brings more than 25 years of experience in business development, technical sales, and account management within the pharmaceutical industry, Peterson joins Coating Place with over 25 years of financial leadership across diverse manufacturing and operations environments.
Source: Coating Place
General
LabVantage Launches AI Platform
LabVantage Solutions, a provider of laboratory informatics solutions and services, has announced the launch of LabVantage Cortex, an artificial intelligence (AI), analytics, and automation platform, which integrates advanced AI and smarter automation into the company’s core LabVantage laboratory information management systems offerings.
Source: LabVantage Solutions
