BioOrganics

API Synthesis & Purification

SAFC offers cGMP synthesis and purification of bio-organic intermediates, excipients and bulk actives.

With over 30 years of experience and expertise in custom APIs scale-up and manufacturing to both Pharmaceutical and Bio-pharmaceutical customers, SAFC has a wide range of expertise to support customers including:

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

Capabilities

  • cGMP compliant, multifaceted facility with fully validated equipment and Part 11 compliant distributive control system
  • (Delta V) monitoring reactor’s parameters, facility’s utilities and USP water system
  • Design compliant with Process Safety Management guidelines to handle large quantities of flammable solvents.
  • Complete segregation, enclosed processing, USP Purified water, process control and HEPA-filtered air that is temperature controlled (~ 70 °F)
  • Manufacturing of 100 kg product quantities batches.
  • 100, 200, 750 and 3000 gallon (375, 750, 2800, and 11,350L) glass-lined reactors that can be heated to 120 °C or cooled to –20 °C
  • Product separation via a Peeler Centrifuge and/or large Vacuum Filter dryers up to 2 m2 in size.
  • Two large walk in hoods using a 50L reactor for small scale manufacturing.
  • Large scale Tangential Flow Filtrations (TFF) expertise and capability
Contact SAFC

Contract Manufacturing Inquiries
For product/service inquiries, quotes or information requests

Manufacturing Facilities