Cell Line Development (CLD)Analytical Method DevelopmentFormulation DevelopmentProcess Development and Manufacturing

Process Development
& Manufacturing

Seamless Solutions from CLD to Patient

By utilizing our established cell line and platform process we rapidly develop and streamline your program development and commercial timelines.

Our process development platform 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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Material generated from the upstream process is used to develop your downstream process as well as provide early stage material for analytical and formulation development.

We optimize your downstream processes to remove impurities and increase yields with minimal steps and optimal recovery.

Our capabilities:

  • Harvest optimization through depth filtration or combined with continuous centrifugation
  • Chromatography steps utilizing all models e.g., affinity, ion-exchange, hydrophobic interaction, metal affinity, etc.
  • Column chromatography from 1 ml through 10 L of bed volume
  • Filter sizing studies
  • Viral filtration determination and viral clearance validation
  • Stability on process intermediates and process hold steps
  • Critical Quality Attributes (CQAs) and Critical Process Parameter (CPPs) validation

Stability

Offering a full spectrum of services, we support stability for drug substance and in-use testing per ICH guidelines. Stability indicating assays are identified early on via forced degradation studies performed during process development.

Following completion of stability time point testing, a final stability summary report is provided to support your clinical studies and market authorization applications.

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We successfully transfer your existing process, or develop new, innovative processes to meet your objectives ensuring your overall success in delivering vital medicines to patients.