Drug Development Support

piCHEM provides support for all phases of drug development

Stage 1 – Basic Research

  • R&D custom peptide synthesis
  • Peptide structure design
  • Synthesis strategy
  • Modification
  • Dye labeling
  • Peptidomimetic
  • PNAs
  • Flexible from milligram to multi-gram scale

Stage 2 – Pre-clinical Development

  • Toxicology lots – Technical lots
  • Initial process development
  • Analytical method development
  • Formulation studies
  • Container compatibility studies

Stage 3 – Clinical Stage - Phase I to III

  • EU-GMP/cGMP production
  • Process scale-up
  • Gram to several hundred grams
  • Process validation
  • Analytical method development
  • Analytical method validation
  • Stability studies
  • GMP documentation
  • QP release
  • Formulation development
  • Aseptic fill & finish service
  • Manufacture of reference material

Stage 4 – Regulatory Affairs

  • Preparation of quality documentation IND/IMPD
  • Preparation of DMF/ASMF
  • Submission of documents to authorities
  • Dossier lifecycle management

Stage 5 – Commercial Manufacturing

  • Production according to marketing authorisation
  • Contract manufacturing
  • QP release
  • Supply management
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Over the last 30 years piCHEM worked within several EU co-financed collaborative projects and has become an experienced and reliable partner for research projects.

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