GMP & non-GMP Manufacturing
Cedarburg Pharmaceuticals, a division of Albany Molecular Research Inc. has the experience and capabilities to help you with either taking your API from the bench to market or simply take your existing process and generate the material you need for toxicity and clinical testing.
Process Development & Manufacturing Facilities
- 4 GMP production suites
- 4 GMP kilo-laboratory suites (2 potent facilities)
- 21 R&D fume hoods
- Isolated drying / packaging rooms
- Glassware up to 200L
- 22L photochemical reactor
- 100L low temperature PTFE lined reactor
- 30 gallon reactor
- 50 gallon reactors
- 100 gallon reactors
- 300 gallon reactor
- 500 gallon reactors
- Emerson DeltaV Digital Automation System
- Ozonizer (up to 100g per hour)
- Preparative chromatography equipment
- Stability chambers (ICH)
- HPLC / UPLC
- GC Mass Spec
- LC Mass Spec
Need help developing synthetic routes and manufacturing processes for your API?
Cedarburg Pharmaceuticals is the ideal solution for companies that need help developing synthetic routes and manufacturing processes. Our project teams are lead by Ph.D. study directors with 10-20 years of drug development experience in large pharmaceutical companies (e.g., Abbott, Pfizer, Eli Lilly, UpJohn) and work closely with our chemists and project management team to routinely develop, scale and validate novel synthetic routes for clients, and oftentimes exceed desired yields and purities.
Already have a process and just need material generated for toxicity and clinical studies?
Instead of requiring new process development, some companies already have well-developed processes for their drug substance and simply need their API material to be generated for toxicity or clinical studies.
Cedarburg Pharmaceuticals can be a valuable partner, using our extensive experience in scale-up and validation projects. For these projects, Cedarburg has a team skilled in developing robust processes amenable to validation and generation of commercial volumes. We have over 25 years of experience validating synthetic processes and providing regulatory documentation in support of CMC filings.
Centralized project management makes a BIG difference to your success.
Strong project management allows Cedarburg Pharmaceuticals to succeed where others have failed. Complex projects with aggressive timelines require a business mindset and detail-oriented oversight, all managed from a central point that ensures all the resources are in place at the right time and every member of the project team is clear about what needs to be done.
Our unique centralized project management system, coupled with the technical expertise and creativity of our scientific staff, ensure timely completion of individual milestones and routinely results in meeting or exceeding project objectives in terms of process development, validation and API material delivery.