Many Cell and Gene Therapy (CGT) companies outsource product development and manufacturing activities to a Contract Development and Manufacturing Organisation (CDMO). It is critical to ensure that an informed decision is made when selecting a CDMO to prevent future disruption to the intricate supply chains of cell and gene therapies and ultimately patients. HiTech Health explores 5 key considerations for a cross-functional team to examine when partaking in the CDMO selection process.
- Does your CDMO have an experienced CGT team?
The complex and time-sensitive nature of CGT manufacturing processes makes it imperative to select a CDMO with a team who have deep knowledge of cell and gene therapies. The technical and regulatory landscapes in the CGT industry are changing frequently and ensuring your CDMO has in-depth expertise and flexibility is crucial to success. Assessing the CGT experience of the proposed CDMO team could reduce the risk of knowledge gaps later. A CDMO may have a strong track record of developing and manufacturing small molecule products and biologics but may have limited experience of CGTs. Are sufficient resources in place now and into the future?
- Is there an integrated project management approach defined by the CDMO?
If you have shortlisted potential CDMO partners, have you enquired about their project management approach? How do the proposed approaches differ among the potential partners? Having an integrated project management approach that ensures seamless alignment between production, supply chain, QC testing personnel and many other functions is paramount given the stringent timeframe for supplying CGTs to patients. Understanding how frequently you will meet with the assigned CDMO project manager and how they will communicate with you should be clearly defined from the beginning.
- Does the CDMO practice effective Quality by Design (QbD)?
Considering if a CDMO practices Quality by Design (QbD) is an important part of the due diligence process. The CDMO team may work closely with you to measure, analyse and report on the quality attributes of the CGT product. The team members who develop your upstream regulatory strategy and initial CMC plan need to be able to work closely with a trusted CDMO partner who can ensure quality and compliance goals are met. Have you considered an on-site audit of the CDMO before the final selection?
- How flexible is the potential CDMO partner?
During the due diligence assessment, look at the CDMO’s internal systems and workflows for a true indication of their fit as a potential partner. The CDMO should be experienced and agile to help you navigate unforeseen challenges, open and transparent to help you mitigate risks and control your costs as well as being fully committed to the ultimate goal of providing CGTs to the patients who vitally need them. These are the characteristics of a resilient and long-lasting partnership, and the indicators of future success.
From the start of a project, the right CDMO will encourage an ongoing dialogue about the quality, pace and cost considerations of your project. They will focus on developing a robust and scalable approach that will work for the entire lifecycle of your project.
- Is there a Business Continuity Plan (BCP) that has been implemented and managed effectively by the CDMO?
The CDMO’s ability to maintain essential functions during and after an unforeseen event has occurred is very important and should be assessed prior to signing a contract. Business continuity planning, in this case, relates to establishing risk management processes and procedures that aim to prevent interruptions to manufacturing and supplying CGTs. If an unforeseen event occurs, such as critical components not being available, how will the CDMO mitigate or manage the issues to ensure the effects on operations are minimised. Have you requested a copy of your shortlisted CDMO’s business continuity plan?
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