Gene & Cell Therapy Technology Transfer
We provide Technology Transfer and Industrialisation support to gene and cell therapy companies, from R&D to development lab, to or from Contract Manufacturing Organisations (CMO’s).
The technology transfer of gene and cell therapy products begins with sharing of all relevant information, including safety aspects (e.g., safety profile, material safety data sheets, biosafety level concerns, etc.) and process (e.g., cell line, manufacturing reagents, process conditions, purification methodology, etc.), and analytical (e.g., protocols, custom reagents, assay standards, etc.) details.
This can be a complex process and is not without its pitfalls which can incur significant time and cost penalties if not carried out properly.
Our team is highly experienced within the biotechnology and the gene and cell therapy sectors having worked in both small and large companies, from R&D establishments through to major CMO’s. We are fully conversant with EMA and FDA guidance’s and regulations.
We can support you in:
- Using a science and risk based approach to your technology transfer process, minimising cost and aligning with business and regulatory expectations
- Scale-up or scale-out of processes
- Creation of a technology transfer pack compliant with CMO requirements, saving you both time and money.
- Provision of dedicated Project Manager who acts in your interest
- Creation of a compliant process definition
- Risk assessments of production process
- Regulatory and technical gap analysis
- Helping you create an industrialisation strategy
- Selection of CMO & preparation of Request for Quotation (RFQ)
- Compilation of product and material safety data sheets, HAZOP studies
- Ensuring GMP requirements are met
- Introduction of automated systems
- Introduction of closed systems
- Working with your vendors to enable industrialisation of manual techniques
- Creation of procurement packages
- Selection, training, co-ordination and facilitation of technology transfer teams and coordinate and / or lead technology Transfer meetings as necessary and manage information flow and decisions.
- Creation of technical reports and contribute to Regulatory Filings and responses to Regulatory questions as appropriate.
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Why choose Bluehatch Consultancy for Gene & Cell Therapy Technology Transfer
- Benefit from our collective depth of knowledge of biotechnology and gene / cell therapy processes.
- As an independent consultancy, we are free to act fully in your interests.
- We have over 20 years’ experience within biopharmaceuticals and gene / cell therapy products.
- Fully conversant with EU and FDA regulations.
- Can act as an independent consultancy or as additional resource to your own teams.
- Our project management, validation, engineering, and technical experts work together to provide you with a holistic service.