Cedarburg Pharmaceuticals

Process Development

API Process Development

Cedarburg Pharmaceuticals, a division of Albany Molecular Research Inc. has the technology and experience to offer you synthetic and semi-synthetic process development as well as natural product isolation and purification.

No matter how simple or complex your API development needs may be we have the flexibility to customize our proven synthetic and organic process development services to meet your exact needs.

Our experienced team of chemists can:

  • Reproduce your existing process verbatim
  • Improve, refine, and optimize your existing synthetic process by developing synthetic or organic processes that will be both flexible and portable with its manufacturing schemes and regulatory strategies
  • Assist you in identifying new, potentially more efficient synthetic routes

Cedarburg Pharmaceuticals ensures that your drug substance will be made efficiently using cost effective processes. We test and validate your API in one of our four manufacturing facilities or isolated GMP suites to make sure it can be scaled up using the synthetic or organic process we develop for you.
All of our routes are designed to be conducted in standard equipment using reliable and proven manufacturing methods to make it easy and convenient for you to transfer the production to another API supplier as your needs grow.

Synthetic Process Development Experience

Prior to employment at Cedarburg Pharmaceuticals, members of our team of senior chemists had major roles in developing the chemistry behind such drugs as Lipitor, Neurontin, Accupril, Biaxin, and Norvir. This industry experience combined with Cedarburg’s proven record of successes has generated a team ready to face your unique challenges, as well as tackle your toughest chemistry problems.

Core Process Development Expertise:

  • Reproduce current synthetic processes
  • Optimize current synthetic routes to improve yields, purity, and reproducibility
  • Identify alternate synthetic routes that are more amenable to large scale production and improve efficiency

Industries served:

  • Pharmaceutical industry
  • Dietary supplement industry
  • Fine chemicals industry

Some examples of synthetic API process development:

  • Oxandrolone
  • Exemestane
  • THC (Tetrahydrocannabinol)
  • Fentanyl
  • Fenretinide

Natural Products Process Development Experience

Cedarburg Pharmaceuticals specializes in the purification of high value and high potency chemicals from complex mixtures. Our chemists have developed proprietary extraction and purification techniques, Dynamic Liquid / Solid Extraction as well as Liquid / Liquid Focusing technologies.

Cedarburg Pharmaceuticals’ expertise also extends to more traditional types of chromatography, including Prep-HPLC and large scale, medium and low pressure chromatography with automated fractionation. These procedures are routinely used by Cedarburg Pharma chemists to purify a variety of materials from natural sources

Core Process Development Expertise:

  • Isolation / extraction and purification of natural products from plant, marine and microbial sources
  • Synthetic modification of natural products to generate APIs

Industries served:

  • Pharmaceutical industry
  • Dietary supplement industry
  • Fine chemicals industry

Some examples of organic API process development:

  • Paclitaxel from Yew biomass
  • Taxanes
  • Michellamine B
  • Artemisinin
  • Tea catechins
  • Natural fatty acids, sterols, terpenes, isoflavones, polysaccharides, alkaloids, nucleosides, and saponins
  • Anti-oxidants
  • Plant proteins