Verta Life Sciences has recently delivered a BLA-ready CMC package for a 4,000L mAb process for a client in record time. In just 2.5 years, we have scaled up from a Phase I 100L process, completed process characterization, validated the Drug Substance (DS) and the Drug Product (DP) processes as well as the analytical methods at the originator sites and transferred the product successfully to three (3) additional commercial DS sites (2 US, 1 in Asia). Verta has done this with a small, dedicated, relentless team.
The experts from Verta Life Sciences represented disciplines from Drug Substance Process Development, Drug Product Process Development, Quality Assurance, Analytical Sciences, Validation, CMC Regulatory Affairs, Clinical Supply, Logistics and Commercial Supply to deliver a commercial Biologics product from CDMOs in this accelerated time.
To learn more about how Verta Life Sciences can help you, please contact us at experts@Vertals.com
Verta Life Sciences’ role
CMC Program Leadership
Verta led the CMC, manufacturing, and supply program on behalf of the client, including:
- Led the program of work by CDMOs to scale up and manufacture additional supplies of the product.
- Maintained an overall program schedule and budget.
- Negotiated and managed development, commercial supply, and quality agreements with CDMOs.
- Update the Manufacturing and Supply Strategy to optimize speed and cost for the product as it progressed towards registration and launch.
- Provided weekly CMC, Manufacturing and Supply updates to client’s management
- Represented CMC, Manufacturing and Supply for the client in various meetings, including FDA, MHRA, EMA, other Government agencies such as BARDA, and external partners.
Supply Chain Management and Logistics
- Updated and managed the product’s Supply and Launch Plan between multiple CDMOs based on a rolling 18-24month forecast
- Updated and maintained the CMC budget and cost model.
- Provided ongoing support for selecting and negotiating logistics and transportation service agreements with Logistics Service Providers (LSP).
- Managed the relationship with LSPs, including day-to-day contact for shipments in transit.
- Provided ongoing Supplier Quality management, including the review and negotiation of Quality agreements and GXP audits as required.
- Established and managed a Quality Management System suitable for late-stage clinical and commercial operations at the client.
- Provided ongoing Quality Assurance, including change control and batch disposition.
- Established and managed Product Complaints and Pharmacovigilance systems.
Scale-Up, Tech Transfer, Characterization and Qualification of Bulk Drug Substance Manufacturing
- With the CDMOs, Scaled up the existing Bulk Drug Substance (BDS) manufacturing process from 250L to 500, 1000, 2000, and 4000L as soon as possible.
- Characterized and qualified the BDS manufacturing process with the CDMOs and updated regulatory files in anticipation of EUA, CMA, and BLA approvals
- Supervised CDMOs’ manufacture and release of BDS batches in support of Clinical trials and in anticipation of Emergency Use.
Analytical Methods, Testing and Stability
- Led CDMOs and Analytical Service providers to establish reliable cell-specific stability-indicating analytical test methods for the BDS and to support the validation of the methods to progress the regulatory submissions and release BDS for use in Emergency Supplies.
- With the CDMOs and Analytical Service providers, established reliable stability-indicating analytical test procedures for the DP to support the regulatory submission and released DP for use in Emergency Supplies.
- Supervised CDMOs and Analytical Service providers test and release BDS and DP for clinical supply.
- Established the protocols and managed the Stability Program required to support the registration and supply of the product.
Scale-Up and Tech Transfer of Drug Product Manufacturing
- Scale up the existing Drug Product (DP) manufacturing process with CDMOs as soon as possible and use the DP to supply clinical supplies, compassionate use, and use under an accelerated/ provisional BLA.
- Tech Transferred the DP manufacturing process to additional DP fill/finish sites.
- Work with CDMOs to manufacture, package, and release DP for the product’s global supply for clinical studies, compassionate use, and under potential EUA, CMA and full BLA registrations.
- Led the overall CMC regulatory program.
- Maintained and updated CMC modules as required to support worldwide filing.
- Co-authored CDMO the BLA/MAA Module 3 CMC sections with CDMOs and others.
- Managed CMC interactions with Regulatory agencies, including FDA, MHRA, EMA, etc.
- Supported updates to the existing IND, as needed to support the EUA/CMA submission, and any other activities required to support the manufacture, registration and supply of the product