Summary
- Profile Type
- Business Offer
- POD Reference
- BOGB20230808014
- Term of Validity
- 8 August 2023 - 7 August 2025
- Company's Country
- United Kingdom
- Type of partnership
- Outsourcing agreement
- Commercial agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- UK biotech company specialising in cell therapy has state-of-the-art facilities and services in Central Europe to offer to organisations needing cell-based R&D support and services. Their protocols were developed in-house to support GMP compliant manufacturing in a purpose-built clean room facility, with areas A, B, C and D. They are now offering access to these technologies and their R&D capabilities as a CRO/CDMO. Cooperation sought would be via a commercial or outsourcing agreement.
- Full Description
-
With the cutting-edge technology and extensive professional experience, they are positioned to offer state-of-the-art services to the pharmaceutical industry. The newly developed GMP-compliant laboratories for mammalian cell culture and production provide Pharmaceutical-grade products and high quality (GLP/GMP)services to their clients include:
• 98m2 clean room
• 250m2 dedicated QC facilities
• Compliance with EU GMP Grade B, US ISO 14644-1, and ISO 14689 Grade ISO5 standards.
• Both QC laboratories and clean rooms (Areas A-D), fitted with laminar flow hoods,
• High-capacity CO2 incubators and associated clean room equipment,
• Storage room with qualified Liquid Nitrogen (LN2) containers for cell banking
• -80oC freezers,.
The GMP-compatible manufacturing services are versatile and designed to meet the specific needs of their clients. The services portfolio includes:
• Regulatory support (IMDP application filing)
• Transfer of R&D technology into GMP-compliant Masterfile for cell therapy products and biopharmaceuticals
• Cell isolation,
• Scalable cell cultivation, manipulation, mesenchymal (MSC) or induced pluripotent stem cell (iPSC) development.
• Development and validation of organoid-based cellular assays
• NGS-based (Next Generation Sequencing) quality control analysis, pathogen tests.
• Aseptic processing (filling, packaging, labelling)
• “Master cell banks” (MCB) and “Working cell banks” (WCB) manufacturing
• Dedicated storage
Collaboration is offered via a commercial and / or outsourcing agreement in order to bring ground-breaking new technologies to market using a state-of-the-art facility. - Advantages and Innovations
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The significant advantages of their services, making them an ideal provider for biopharmaceutical and cell therapy product developments, include:
• Purpose built clean room facility, located in Central Europe, that is compliant with the requirements of GMP cell manufacturing.
• Their team has a deep understanding of the latest technological advancements and regulatory requirements in the industry. Their extensive research and commercial experience ensure they can provide a comprehensive range of services from R&D to commercial manufacturing .
• Their cell isolation and quality testing laboratories comply with strict GLP principles, ensuring that their clients receive the highest quality product .
• They offer a wide range of NGS-based genetic analysis, providing the appropriate QC methods to support the manufacturing processes, or where required as separate, standalone service.
• They can customise services to meet the clients' specific needs, including transfer of R&D technology into GMP-compliant production settings, making them a preferred partner for biopharmaceutical and cell therapy product development.
In summary, the client offers a comprehensive combination of technical expertise, advanced development and production facilities, and customised services positioning them an ideal partner for the pharmaceutical and biotech industry. - Stage of Development
- Already on the market
- Sustainable Development Goals
- Goal 17: Partnerships to achieve the Goal
- IPR status
- IPR applied but not yet granted
Partner Sought
- Expected Role of a Partner
- The expected role of the partner is to establish a collaborative relationship with the facility to enable successful commercialisation of their new innovative technologies via a commercial and / or outsourcing agreement. Partners could be biotech or pharmaceutical companies of all sizes.
- Type and Size of Partner
- SME 11-49
- University
- SME <=10
- Big company
- SME 50 - 249
- R&D Institution
- Type of partnership
- Outsourcing agreement
- Commercial agreement
Dissemination
- Market keywords
- 05004003 - Laboratory equipment
- 04013 - Stem cells and biobanks
- 05009003 - Animal health
- Targeted countries
- All countries