GPP Services
Because GMP Requires Great Process Protection!
Your Bridge to GMP Confidence
If you are ready to advance that promising drug candidate to the clinic, we can help eliminate surprises with our GPP (GMP Predictive Preparation) services. Once you select your CDMO, the production schedule will be locked in based on their availability and some high-level estimates and assumptions. Your team may be incredibly competent and flexible, but tech transfer is an intense and intricate process where complications cause expensive delays, and the occasional compromise. Complications that will only reveal themselves after the campaign begins and the clock is ticking. Unless you are GMP prepared!
GPP Provides Risk Reduction and Predictability at 2% Cost
Get GMP-prepared with GPP!
In as little as 2 months, we can find and address potential process issues and bring peace of mind to your CMC team. We build our menu of services to test assumptions and reveal unknowns. Reduce risk and allow your CDMO partner to focus on a smooth, predictable production campaign.
Choose from an assortment of services such as:
- Proving runs to demonstrate the performance of your process – yield, purity, potency and other release specifications.
- Process development for troubleshooting a single step, or designing a complete process for tech transfer.
- Material generation to provide ample, well-characterized protein for consistent bench and pre-clinical investigations. Formulated (and reformulated) to order.
- Reference standard banks for analytical assay transfer and qualifications.
- Preliminary studies for predicting formulation, stability and viral clearance.
We provide secure IP documentation and professional liability insurance. We understand the need for contingencies, and the value of conclusive results. Our facility in Marlborough gives you fast access to the Boston biotech ecosystem.
As an independent contractor, we have the freedom to provide a customized approach, with insight and perspective that feels more like an extension of your team. We work for you, with you! Contact us for more information.