Selecting the right CDMO to get lentiviral vectors according to the cGMPs is an important choice for a cell and gene therapy company, but very hard to handle. Choosing a CDMO with strong expertise and experience as a lentiviral vector manufacturer is crucial but not enough to be chosen as the best CDMO.

Here are the top five criteria to consider when making your choice.

1. Long experience in the field

Strong expertise in both the construction and production process of lentiviral vectors is essential for a CDMO in order to meet all of your specific project needs and anticipate all the questions related to the clinic’s requirements. Expression plasmid design must be understood in terms of ultimate efficiency and level of expression of your transgene(s) of interest. Production process must be flexible enough to adapt to your project as needed and scaling up should be strictly managed.

2. Continuum from Research to Clinical grade

Combining know-how and high-tech processes, the CDMO must make available small, medium and large-scale productions of high-quality vectors with the same attribute specifications, from R&D to GMP-grade, in order to support you throughout your project, from discovery to clinical phases. This will speed up your project to take the leap from research to clinic.

3. Timeline and capacities

The CDMO must define with you the right timeline of your project, from preclinical stage to commercialization, with the option of slot reservation and process scale-up qualification/validation.

4. Expertise in controls and procedures

Strong expertise in Quality Controls, Analytical Development, Regulatory affairs for lentiviral vectors used as Starting Material or Drug Product:

1. Dedicated QC plan, development of analytical methods according to your needs
2. Regulatory and CMC expertise

5. Dedicated team to support you throughout your project

A good CDMO must support you in the design of your project before taking care of all steps to provide the best lentiviral particles:

• Expression cassette design : choose the suitable genetic elements to guarantee the best expression cassette (promoter, multicistronic elements, selection marker)
• Upstream/Downstream process expertise

Production process adapted to the final batch volume and regulatory requests corresponding to phase I, phase II, phase III and comercial product. Anticipation of the supply of biopharmaceutical raw materials and plasmid manufacturing slots.

• Project follow-up
  Regular meetings with a dedicated project manager, scientific advisors, QA and QC manager to ensure project follow-up and accomodate your timeline changes. A strong partnership, hand-in-hand to meet your needs.

 

Conclusion

The choice of CDMO may well be one of the most important factors in ensuring project efficiency and cost-effective steps to clinical use and further commercialization. When activities align, efficiency is gained from better communication among drug substance and drug product teams, project manager-controlled timelines.

Moreover, when CDMOs have significant experience, they can better anticipate and avoid issues that could be problematic for scale-up and approval.

Ultimately, bringing clinical projects to therapy and commercialization is always a stressful and risky process; your CDMO should not be among these challenges!

 

Régis Gayon Vectorology & Cell engineering Manager Flash Therapeutics expert since 2005

 

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