Complex ChemistryPolymer/NanoparticlesAnalytical Method DevelopmentFormulation DevelopmentProcess Development

Process
Development

Seamless Solutions from Concept to Patient

By utilizing our deep knowledge of chemistry, we rapidly develop and streamline your program development and your clinical and commercial timelines.

Our process development approach is defined and designed to ensure scale up directly from bench scale to final manufacturing.

Applying decades of experience, we successfully transfer your existing process, or develop new, innovative processes to meet your objectives.

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Our Capabilities

Our development capabilities include:

  • Process development for small molecules, including high potency chemistry
  • Multiple linker chemistries
  • Bench scale process characterization and validation
  • Design of statistical experiments to optimize processes
  • Transfer verification optimization of your process

Material generated is used to develop your early-stage material for analytical, formulation and lyophilization cycle development. Process Development works with Analytical Method Development (AMD) to determine your program quality attributes, design stability programs for process intermediates, and define your process hold steps. Our Process Development team determines the Critical Quality Attributes (CQAs) and Critical Process Parameter (CPPs). We design your processes to optimize yields and remove impurities with minimal steps and optimal recovery.

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Using a diverse range of expertise in developing and manufacturing ADCs, bioconjugates and linker payloads, we create tailored solutions for your program.

We adapt our approach to shorten lead times and develop risk mitigation strategies to ensure your overall success in delivering vital medicines to patients safely.