Drug Substance Manufacturing

Avista Pharma Solutions has a demonstrated, unique ability to perform cGMP manufacturing of drug substances as well as non-cGMP custom synthesis (e.g. for materials that are under development) for new or transferred substances.

cGMP Manufacturing

Avista Pharma operates multiple cGMP kilogram-scale labs (kilo labs) to demonstrate particular manufacturing processes and to supply critical API for support of clinical through Phase II  studies. Our experienced Quality Assurance (QA) department ensures that detailed documentation, adherence to SOPs/federal guidelines and laboratory controls are maintained.

 

cGMP Services Include:

  • Preparation of active pharmaceutical ingredients (API’s) under cGMP controls
  • Development and outsourced manufacturing of regulatory starting material (RSM)
  • Phase-appropriate analytical method development and validation
  • Materials characterization and release testing
  • Process validation
  • Cost of goods (COGS) analysis
  • Technology transfer
  • CMC Quality eCTD module documentation for Investigational New Drug (IND) and Investigational Medicinal Product Dossier (IMPd) submissions

Avista Pharma’s Quality Management System Provides:

  • Comprehensive Quality Agreements
  • Phase-appropriate cGMP
  • Utilization of quality risk management principles
  • Commitment to quality and continuous improvement

Non-cGMP Custom Synthesis

Projects for custom synthesis may or may not have a defined synthetic route described in a technical package and can require milligrams to kilograms quantities of material. We provide rapid access to target structures that require multi-step organic syntheses. Custom synthesis projects often support drug discovery or early-stage development efforts. Selected examples include:

 

  • Route design, optimization and synthesis/scale-up of a structurally complex target designed from existing SAR data, for biological evaluation in support of a MedChem discovery program
  • Isolation and structure determination of process impurities, degradants or metabolites for an API using LC/MS and chromatographic isolation coupled with advanced Nuclear Magnetic Resonance (NMR) technology
  • Custom synthesis of identified or suspected process impurities, degradants or metabolites for an API to confirm the structure(s) or serve as a marker or reference standard for determination of relative response factors (RRF)
  • Production of various quantities of material for GLP toxicology studies