Cedarburg Pharmaceuticals

GMP Kilo-Scale Synthesis and Manufacturing

GMP KilolabThe best way to keep costs down during the early phases of your drug development project is by working with a company that specializes in kilo-scale synthesis and manufacturing.

Cedarburg Pharmaceuticals, a division of Albany Molecular Research Inc. has the experience and expertise helping our clients quickly and economically develop processes to synthesize and produce a few non-GMP grams of their compound in our labs for toxicity trials as well as scaling the process up to manufacture up to several kilograms of GMP material in our GMP kilo-scale labs and suites for their clinical trials.

We have experience successfully manufacturing not only our clients’ APIs, but our own commercial APIs as well. The APIs have included potent compounds, controlled substances and a variety of compounds that have required complex chemistry. We know what it takes. We understand what is important. We know how to get the job done efficiently and economically, factors that are critical during early phase projects.

Do you need an experienced kilo-scale synthesis and manufacturing partner for your current or upcoming project? Contact us now to discuss your project!

GMP Kilo-Scale Quality Systems, Procedures and Controls

Cedarburg Pharmaceuticals has designed our quality systems, procedures and controls around ICH Q7 to meet cGMP requirements for APIs. We have SOPs surrounding critical elements including…

  • Raw material receiving and sampling
  • Raw material testing and release
  • Equipment cleaning
  • Material specification approvals
  • Quality assurance batch record approvals
  • Final product release
  • Corrective Action Preventative Action (CAPA)
  • Incident investigations
  • Deviation reporting
  • Out-of-specification investigations
  • Control of cross-contamination
  • TSE / BSE risk analysis
  • A comprehensive list of GMP procedures

GMP Kilo-Scale Laboratories & Equipment

GMP LabCedarburg Pharmaceuticals has 4 GMP kilo-scale labs that have the capability to produce just a few grams of your material during the early stages of development up to several kilograms of GMP material for clinical trials.

Our labs have

  • Dedicated HVAC systems for each suite with single-pass air controls to prevent cross contamination
  • Cascading pressure differentials between the labs and the hallways
  • Temperature controls that can range from -10 to 120 degrees C
  • Air locks that provide environmental isolation protecting the GMP labs from outside contaminants
  • Keycard security systems for potent compounds and controlled substances

Our equipment can be easily adapted to your project’s needs

200L GlasswareWe have the flexibility to match our equipment to your processes – We don’t just match your processes to our equipment. Because we have a wide variety of types and sizes of glassware and equipment that we can quickly and economically move in and out of our GMP kilo-scale labs, we can easily adapt to the changing needs and stages of your project. Our equipment includes…

  • 21 R&D fume hoods
  • Up to 200L glassware / reactors
  • Isolation & filtering equipment
  • Jacketed vessels allow us to heat and cool your products in the reactors quickly, evenly and cleanly
  • Column chromatography
  • Lyophilzation equipment
  • Hydrogenation equipment
  • Ozonizer (up to 100g per hour)

Your project will also have easy access to our on-site analytical labs and equipment which includes

  • UPLC with TUV detector, Waters Acquity
  • HPLC with VWD & DAD detectors, Agilent 1100, 1200
  • LC/MS, Thermo Surveyor MSQ
  • GC with FID & TCD detectors, Agilent 6890, 6890N, 7890
  • GC Headspace auto-sampler, PerkinElmer Turbomatrix 40, Agilent G1888
  • GC/MS, Hewlett Packard 5972
  • IC, Dionex ICS-2000
  • FTIR Spectrometer, Bruker Vector 22
  • FTIR Spectrometer, PerkinElmer Spectrum 100
  • UV/Vis Spectrophotometer, Shimadzu 1601PC
  • Polarimeter, Rudoph Digipol 781
  • DSC, TA Instruments Q100
  • Halogen Moisture Analyzer, Mettler Toledo HG53
  • Autotitrator, Mettler Toledo DL55
  • Karl Fisher Coulometric, Mettler Toledo C20
  • Karl Fisher Volumetric, Mettler Toledo DL18

See additional information about our analytical method development, optimization and validation services

We Can Scale with the Growing Requirements of Your Project

We have the experience, expertise, equipment and facilities to scale your early stage development needs into greater quantities as you move through the phases of development and into commercial production. Your drug development and manufacturing project can be seamlessly transferred from our smaller bench-top hoods to our walk-in hoods and finally into our complete GMP production suites that house reactors up to 500 gallons.
We can scale-up to your specific needs without the challenges often associated with transferring the technology from supplier to supplier.

Our scientists are skilled and experienced at scaling our clients’ projects within our own facilities and managing their projects efficiently and economically.

Next Steps

Do you need an experienced kilo-scale synthesis and manufacturing partner for your current or upcoming project? Contact us now to discuss your project!

We also provide a comprehensive suite of API development services for you project, including…

  • Process development, optimization, scale-up and technology transfer
  • Analytical method development, optimization, scale-up and technology transfer
  • Development of complex chemistry, handling potent compounds and controlled substances
  • Quality control and assurance
  • Regulatory assistance, CMC/DMF filings