858-449-1310 contact@somatek.com

OUR SERVICES

Somatek’s service offerings focus on Chemical Methods and Controls (CMC) for FDA and EMA regulated biologics

Outsource Management

  • RFP generation and bidding process
  • CMO/CRO selection and negotiations
  • project/program management
  • routine and for cause audits

Process Development & Manufacturing

  • antibodies, ADCs, other constructs
  • enzymes, cytokines, fusion proteins
  • viruses (adenovirus, AAV, lentivirus, etc.)
  • diagnostics (IVD, POC, imaging agents)

Assay Development / Establishment

  • biochemical and cell based assays
  • in vivo model development
  • toxicology & pharmacology
  • assay characterization

Quality Assurance (QA)

  • document systems and controls
  • facility & equipment IQ/OQ/PQ
  • processes qualification & validation
  • quality systems and training

Formulation/Stability

  • liquid and frozen formulations
  • lyophilization formulations and methods
  • product stability and characterization
  • accelerated/forced degradation

Quality Control (QC)

  • assay qualifications
  • assay validations
  • materials testing
  • microbiology

Audits, Due Diligence, Investigations

  • chemical methods & controls (CMC)
  • project feasibility (resources, timelines)
  • compliance (FDA, EMA, GMP, ISO, ICH)
  • failure analysis (OOS, root cause, gap)

Regulatory Affairs and Strategies

  • chemical methods & controls (CMC)
  • pre-IND preparations
  • agency interactions (FDA, EMA)
  • filings (INDs, annual reports, BLAs)

Research Products

  • development
  • research reagents
  • kits