Complex APIs

We offer cGMP synthesis and purification of bio-organic intermediates, excipients and bulk actives. With more than 30 years of experience and expertise in custom APIs scale-up and manufacturing for both pharmaceutical and biologics, we can effectively support your needs for:

  • Polyamino acids including Poly-L-Lysine and others
  • Carbohydrates
  • Lipids
  • Detergents
  • Buffers
  • Custom processes derived from a variety of plant derived natural or synthetic sources

Capabilities include:

  • cGMP compliant, multifaceted facility with fully validated equipment and Part 11 compliant distributive control system
  • Delta V monitoring of reactos parameters, facility utilities and USP water system
  • Large scale tangential flow filtrations (TFF) expertise and capability
  • 20L and 200L lyophilizers