Are you outgrowing your current CDMO and need additional capacity for Phase 2 or 3? Or are you evaluating the security of your supply chain for your commercial assets? Recro has the capacity and expertise to transfer in your product’s technology regardless of development phase or situation.
Goals of Technology Transfer
Technology transfers are a valuable and important step in the development life cycle leading to successful pharmaceutical commercial manufacturing. The goal is to take an existing product and the process knowledge gained during development and manufacturing and use it as the basis for the manufacturing control strategy and approach to process qualification. Once we verify that the parameters established during development are within the design space or adjusted at scale-up, we can achieve product realization. At Recro®, we deliver a turnkey process that makes the transfer go smoothly for everyone. Our process is customized for each product’s unique technical challenges, goals, and objectives. We work closely with our clients to ensure the fastest, most efficient technical transfers with the highest probability of technical and regulatory success.
Why Partner With Recro for Your Next Technology Transfer?
Recro has a history of success with technology transfers from early development formulations to scale-up/late-stage and commercial products. At Recro, we have the tools and expertise needed to take your project from start to finish.
Quality Minded Business
- Strong FDA-compliance record
- Robust quality system
- Strong sustainability program
Proven Commercial Reliability
- OTIF greater than 99%
- RFT greater than 95%
- Business continuity plan
- Dedicated, experienced tech transfer team
- Recent successful tech transfer experience
- Expert scientific and manufacturing staff
- Expert regulatory affairs team
- Numerous NDA product approvals
- Decades of commercial supply experience
- 1 hour from one of the largest airports (Atlanta International Airport)
- 4 hours from one of the world’s largest ports (Port of Savannah, the largest single container terminal in North America)
- Low-risk zone for snowfall, earthquakes, wildfires, and floods
- Insulated from coastal weather events
- All operations are in the continental USA
Talk to Our Experts
Interested in learning more about how Recro’s unique approach to technology transfers will save you time and money? Contact us now!