Contract Manufacturing Supporting Services

SAFC’s Contract Manufacturing Solutions offer analytical and process support at all stages of drug development and manufacture. From pre-clinical through commercialization, we enable customers to bring their products to market in the most efficient timeframe possible.

Discovery & Pre-clinical Development Services

Working in state-of-the-art laboratories, SAFC can help optimize lead compounds so that they are suitable for progression into customers' pre-clinical development programs.

Discovery Research Services

  • Compound design and optimization
  • Focused compound library production
  • Building block / Scaffolds / Intermediates synthesis
  • Medicinal chemistry
  • Elucidation of processes suitable for scale-up
  • Parallel synthesis of analogs on a larger scale
  • Metabolites and standards
  • Synthesis on milligram to gram scale

Rapid Scale-up for Early Stage Drug Development

Once a development candidate has been identified, SAFC can rapidly develop processes and supply the necessary quantities of API required to efficiently support pre-clinical studies and advance lead programs in the shortest possible timeframe. Our large R&D chemistry teams have combined their extensive experience to develop a fast and flexible pre-clinical chemistry scale-up service.

Pre-clinical Scale-up Services

  • Experienced chemistry team focused on rapid process R&D
  • Seamless process transfer to production environment
  • Vessels ranging from 20 L to 200 L, including hydrogenation
  • Comprehensive in-house analytical support services

Process Development Services

SAFC has an excellent worldwide track record for process development, converting complex and expensive chemical and biochemical synthesis or purification steps into a practical, cost effective process.

In-house process development groups offer early stage process development in order to provide a seamless technology transfer to facilitate crucial speed-to-market demands, and to minimize potential risk involved in the transition between the laboratory, pilot plant and commercial scale manufacturing.

Process Development Capabilities

  • Technology transfer capabilities
  • Complex multi-step synthesis
  • Robust biological processes
  • Complex scale-up services
  • Screening of key process parameters

Analytical Testing

Our qualified personnel use validated instrumentation to perform method development, analytical validations, and verification to the most rigid specifications to ensure cGMP compliance of all released batches.

SAFC Quality Control (QC) operates in accordance with ICHQ7A and 21CFR parts 210 and 211 testing as appropriate for the product and clinical phase. Services include:

  • Analytical methods development, transfer and validation
  • Testing of raw materials, in-process control, stability samples and final product release
  • Stability program management
  • Cleaning effectiveness testing

SAFC offers validated release tests to its clients as part of its 'single-source' philosophy. Not only can SAFC source high quality raw materials, building blocks, and key intermediates, we can manufacture the API and provide validated release tests for those APIs. Testing specific to custom products such as residual solvents, chirality, and the presence of related substances are also available.

We provide complete analytical support, including development of specifications, risk-assessment and implementation of process controls.

Analytical Testing Capabilities

Amino Acid Analysis (AAA)
Bioburden
DSC
Electrophoresis
ELISA
Endotoxin
FT-IR
GC
GCMS
HPLC
IR
KF
LCMS
NMR
TGA
UHPLC
UV
X-ray diffraction
  • Phase-specific analytical development and method validation
  • Characterization, certification and control of incoming raw materials
  • Quality Control (QC) testing of in-process materials
  • Release testing available
  • Stability studies of drug substance and drug product
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Contract Manufacturing Inquiries
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