Downstream Process Development

LakePharma provides downstream process development (DSP) services for all protein based technologies to engineer purification processes for manufacturing. Our technical team has developed purification schemes for hundreds of unique proteins for pre-clinical tox material. Our platform processes are designed to maximize purity and yield, while minimizing the time between development and toxicology studies. The developed processes are tailored to meet our client's specifications.

LakePharma offers two standard DSP platforms:

  1. Antibody/Fc fusion proteins/bispecifics
  2. Non-antibody based proteins (cytokines, growth factors, anticoagulants, vaccines, enzymes)

Services include:

  • Chromatography capabilities include all modalities (affinity, IEX, HIC, multimodal)
  • Virus inactivation (pH and detergent)
  • Ultrafiltration and Diafiltration
  • Weekly updates and study reports and direct communication with the technical team
  • All processes readily scaleable for manufacturing
  • Services can be performed in parallel with upstream and analytical development services to reduce the time between development and toxicology studies