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CMC Process Development

Once your molecule (NCE, intermediates or RSM) requirements are defined, we will develop and optimize the chemical processes in a highly customised way. We follow a “phase-appropriate” strategy to achieve the highest quality products in a cost-effective manner with a strong emphasis on delivering the material on time with sustainability built-in. Complex chemistry is our main expertise.

Process Research & Development

Route scouting:

Our scientists and engineers have a strong track record in establishing alternative route of synthesis which are operationally simple and cost effective as well as environmentally responsible.

Process optimisation:

To achieve highest quality of products, we conduct detailed optimisations within the scope of the project. Our team has deep experience in scaling up most types and classes of organic reactions including:

  • Organometallic
  • Pd mediates Reactions
  • Asymmetric Synthesis
  • Resolution of stereoisomers
  • Hydrogenations
  • Cryogenic Reactions
  • Reduction & Oxidation Reactions
  • Heterocycles
  • Carbohydrate Chemistry
  • Nucleosides

Analytical method development:

During the process development, our AR&D scientists will work alongside the chemists to develop appropriate analytical methods to check, monitor and control the chemical processes.

CMC Process Development at Primopus

Impurity identification, isolation, and characterisation:

We isolate, identify, and synthesize process related impurities and reference standards to support process and analytical method development and regulatory requirements. We assess the fate and purge of these impurities in the downstream chemistry.

Defining critical process parameters:

Fundamental to ensuring a process and high quality process is to define critical quality attributes (CQA) and critical process parameters (CPP).

Phase appropriate approach for chemical development

Early phase model:

We understand that the focus is to get the initial quantities of NCE’s quickly to progress with pivotal Tox, Formulation and FIH GMP studies. We align our process development and scale-up activities accordingly with Time and the right quality being the main driver.

Late phase model:

We have a strong track record for developing and manufacturing NCE’s and APIs for late phase clinical stages and commercial supply. We apply design of experiment and quality by design approaches for the process optimisation and validation of the chemical processes.

CMC Process Development at Primopus

Technology Transfer Pivotal to Success in Scale-up

Technology developed in the above scenario is transferred for scale-up to the defined manufacturing sites following a systematic and team-based approach. Technology transfer packages transferred to manufacturing sites reflect the synthetic chemistry, analytical test methodologies, safety practices & controls and environmentally friendly disposal.

Contact us for more detailed information on how we can help you solve your development needs.