Stage Appropriate Quality Management Systems
It is now widely acknowledged that cell and gene therapies can only be progressed to the clinic when an appropriate quality management system has been used to document their development. This is not an insignificant undertaking and is a specialist skill. The purpose of the QMS is to evidence control of a process, providing investors and regulators with assurance that technologies are fit for purpose. Although the requirements for a QMS system are broadly similar, they must be tailored to the product, the facility in which the development is being undertaken and must take into account the stage of development so as not to constrain it.
We can provide a tailored skeletal system using our unique experience which can either be handed over to clients for internal management, or which can be managed remotely by Regen CTC specialists. We can also support training to work within the system for a client’s workforce, guidance and ongoing support as systems are expanded and we can offer independent internal audits against it for compliance monitoring and as part of a continuous improvement programme.
Cell Line Selection
Based on our considerable experience in the human pluripotent stem cell field, one of the more challenging areas in terms of cell line selection, our Regen CTC specialists can assist you to undertake a risk assessment of your desired starting cell line or perform due diligence on your behalf, to select the most suitable line for your ongoing product development. This will include consideration around geography, donor eligibility, consent, and cell bank production.
Supplier Qualification and Raw Material Selection
Assessing and auditing suppliers and obtaining the necessary documentation for traceability for each of your raw materials, contract analysts and suppliers/ contrators can be a time-consuming, but necessary, activity. We understand that this can be particularly challenging for early developers who have small teams. However, establishing relationships with suppliers, seeking out preferred and alternative sources to ensure continuity of provision, is critical even through the early development stages.
At Regen CTC we have experience of undertaking this process for early-stage developers and can support you in this activity.
Selecting a Contract Manufacturing Partner or Facility
As an advanced therapy product is developed, the process will ultimately need to be transferred from your specialist research lab to a non-specialist but competent manufacturing partner or facility. Selecting a partner or facility can be a key step to your developmental pipeline.
At Regen CTC, we can help you with this selection process by helping to identify and short list possible facilities and/ or undertake due diligence of your contract facilities. In addition, we can also support and facilitate process transfer.
For some, contracting out manufacturing will not be a desired route, and in cases where the intention is to build your own facility, we can help to guide you through this process, using our experience of working in these facilities to develop advanced therapies and knowing some of the pitfalls. We would recommend engaging a specialist CQV (Commissioning, Qualification and Validation) company to undertake these activities, but Regen CTC can liaise and undertake the end-user/ quality assurance support side of this process.
In partnership with Advance Bioprocess Services, Regen CTC can assist you with your cell and gene-based therapy manufacturing design. With considerable expertise in this area, we can help you to improve production yield (intensification), robustness and quality and hence provide regulators and investors with evidence of documented manufacturing control.
Gap Analysis and Due Diligence
When venturing into a regulated environment, it can be daunting, and sometimes, an independent review of your processes can provide peace of mind. At Regen CTC, our goal is to make sure your quality management needs are stage appropriate and that you are not being over burdened whilst trying to comply with regulatory requirements.
At Regen CTC we undertake a GAP analysis to highlight areas of vulnerability or undertake due diligence of your processes, so that you can make informed business decisions, and initiate corrective actions where needed.
Clinical Trial Design
With our clinical specialists at Regen CTC and our experience of having led clinical trials within the advanced cell therapy space, we can help advise you with your clinical trial design, taking into account patient considerations and a knowledge of what regulatory bodies in the UK and Europe have previously required.
Contract Research Opportunities
As an academic network, specialising within the fields of regenerative and advanced medicines, there are many partnership opportunities to help you to progress your product development. Whether that relates to technical challenges, manufacturing, or undertaking or developing QC assays.
If you are interested in partnering with an academic, Regen CTC would be happy to introduce you to its network.