From process development to commercial readiness — executed with speed, clarity, and GMP control.
We support biotech and ATMP companies scaling from clinical to commercial manufacturing. Whether you are transferring a process to a CDMO, internalizing production, or scaling up a platform technology, we ensure your technology transfer delivers compliant, reliable, and reproducible results.
Why Technology Transfer & Scale-Up Matters in Biotech
Technology transfer is not just a tech package and a handshake. It is a high-stakes transition where process, compliance, and business must align.
• Poorly managed transfers lead to delays, failed batches, and regulatory risk
• Internal scale-ups often reveal QMS or validation gaps too late
• Pressure to move fast must be balanced with execution quality and GMP control
You need senior support that understands the science — and knows how to make it work at GMP scale.
What We Deliver
- Tech transfer strategy, planning, and execution
- Process transfer documentation (e.g., TTPs, MPDs, MMRs) and GMP readiness
- Support for in-house scale-up or transfer to CDMOs
- Cross-functional coordination between Quality, TechOps, and Manufacturing
- Validation oversight: process, cleaning, and equipment
- QMS readiness and change control during tech transfer
- Risk identification and mitigation from lab to GMP production
Why Choose GMP Bridge
- Senior experts with experience in scaling biologics and advanced therapies
- Hands-on transfer execution — not just high-level planning
- We align tech transfer with GMP, regulatory, and business needs
- Support across CDMO onboarding, internal facility scale-up, and validation