Process development & validation

At Cambrex, we take a proactive approach to pharmaceutical process development and validation. We use our experience and expertise to efficiently bring your small molecule intermediates and APIs from early clinical phase to commercial production.

Capabilities & Services

Our pharmaceutical process development services combine creative solutions to early phase challenges with a thorough knowledge of the rigours of validation. As a result, we can help you to avoid late stage process changes, which could impact your time to launch. The result is more efficient preparation of your APIs and intermediates and greater confidence in your project’s success.

Our analytical capabilities and pharmaceutical process development services include:

  • Analytical method development and phase appropriate validation
  • ICH stability studies (storage and testing)
  • Reference standard qualification
  • Product release/product retain
  • Route selection
  • Literature/database/patent searches
  • Go/no-go feasibility evaluations of key reaction steps
  • 1-10-gram proof-of-concept lots
  • Toxicology lots for pre-clinical supply
  • Clinical drug substance supply

Process Development Research

Cambrex’s chemists have extensive experience in designing and optimising processes for efficiency, robustness, safety, environmental impact and cost. An investment in PD research often reduces the cost of goods associated with an API through the optimisation or replacement of expensive and/or inefficient synthetic operations.

If necessary, a more efficient manufacturing route can be identified and developed to facilitate material throughput in support of a development programme. Cambrex strives to rapidly deliver innovative technologies to solve PD challenges and advance development programs.

Cambrex’s services for Process Development Research include:

  • Discovery chemistry intermediates and analogs preparation from milligram to kilogram scale
  • Custom synthesis
  • Route discovery, selection and definition
  • Process improvement and optimization
  • Robustness and process limits testing
  • Synthesis of analytical reference standards
  • Metabolite, degradant and impurity synthesis
  • Reference standards and impurity qualification
  • Impurity isolation, identification and structure elucidation
  • Preparative chiral and achiral chromatography (LC)
  • pGTI identification
  • Quality by Design (QbD) process evaluation
  • Statistical Design of Experiments (DOE)
  • Determination of critical process parameters (CPP) and critical quality attributes (CQA)
  • Fate and Purge of Impurities
  • Process scale-up and demonstration
  • Solid state chemistry –salt selection, polymorph screening, amorphous dispersions, crystallization development
  • Hazard evaluation
  • Phase appropriate analytical method development

Contact Cambrex

We’re always available to offer a helping hand at Cambrex. No matter what your question or query, our experts are well-equipped to help.

Contact Us