Technical Development

Alava’s scientists and engineers have carried numerous products through early development, transition to commercial operations, and launch. Biotechnology products are complex and regulatory expectations evolve rapidly, so a robust technical development program will be critical for success. Outsourced technical development is less straightforward than GMP manufacturing or testing, so vendor selection and management is critical. For a lean program, Alava will help find an approach to reach the next milestone with acceptable cost and risk. For clinical stage development, we can develop programs for yield and consistency improvement, and apply DOE and QBD approaches to development activities. For biosimilars and transition to commercial-ready production, we can develop comparability and validation strategies, support scaleup and tech transfer, and help prepare for pre-approval inspections.

Process and Product Development Expertise:

  • Cell line development and GMP banking
  • Supply and characterization of tox material
  • Upstream process development
  • Downstream process development and viral clearance studies
  • Process ranging studies
  • Formulation and drug product development
  • Stability assessment, shipping and storage
  • Small molecule synthesis and purification
  • Drug delivery
  • Tech transfer
  • Clinical administration support

Analytical Expertise:

  • Cell based and potency bioassays
  • PCR and sequencing
  • Chromatography and LC-MS
  • Gels
  • Impurity assessment including HCP, HC-DNA and product variants
  • Small molecule chemistry assays
  • Stability indicating assays
  • Quality attribute assessment
  • Consistency and comparability studies