Outsourced manufacturing and development is increasingly common in the biopharmaceutical industry. It is an attractive solution allowing companies to tighten timelines, reduce the impact of clinical risk on internal plant occupancy, and to keep lean teams focused on discovery and clinical development. Typically, it is faster, and lower cost, to transfer a process into an existing facility than to build and qualify a new site. Clinical material is usually manufactured in short campaigns to supply relatively lengthy trials. It may only be necessary to manufacture every other year. A purpose-built facility could be idle for long periods. CMOs provide available facilities and staff, but may not be as flexible with batch scheduling as an internal facility. Reliable forecasts are important to ensure material supply.
The keys to a successful outsourcing partnership are to match the sponsor’s needs with the a CMO/CDMO possessing the right capabilities, and to maintain appropriate oversight throughout tech transfer, development, and manufacturing.
Amylaza Consulting helps clients from RFP to PV and beyond. We have extensive contacts at CMOs/CDMOs and an exhaustive database of companies active in the space to aid in a site selection. We are experienced transferring processes from lab to CMO, and from CMO to CMO. We will serve as the sponsor’s representative to manage the project and relationship with the CMO, or as advisors to a team on one side of the tech transfer.
As search consultants, we’ll help clients draft RFPs, and manage initial contacts with CMOs. We will coordinate joint approval of confidentiality agreements (CDAs) before circulating the RFPs or discussing process or product specifics. Client confidentiality is a priority for us. Amylaza can manage technical discussions and requested clarifications to help potential partners deliver a detailed proposal. We will summarize the proposals for our clients and suggest the best fits. We advise clients to perform site visits and a full Quality audit before contracting for GMP work.
Once a CMO/CDMO has been selected, Amylaza can drive, or support, a program as required by our clients. We provide the following services for outsourced development and manufacturing:
- Tech transfer plans
- Effective kick-off meetings
- Project management for the sponsor
- Direction for process development
- Person-in-plant
- Technical troubleshooting
- Validation master plan and protocol authorship or review
- Batch record review and data trending
- Pre-approval inspection preparation and on-site support