Linker PayloadsBioconjugates and Antibody Drug ConjugatesAnalytical Method DevelopmentFormulation DevelopmentProcess Development

Process
Development

Seamless solutions from concept to patient

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

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

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Our Development Capabilities

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

Our experience goes beyond ADCs, including bioconjugates, oligonucleotides, nanoparticles, and vaccines.

Development capabilities include:

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

Our Design Capabilities

Process Development works with Analytical Method Development (AMD) to determine its quality attributes. We design your processes to optimize yields and remove impurities with minimal steps and optimal recovery.

Our capabilities include:

  • Conjugation reaction optimization
  • Chromatographic purification steps including ion-exchange, hydrophobic interaction, metal affinity, etc.
  • Column chromatography from 1ml through 20L of bed volume
  • TFF step optimization
  • Filter sizing studies
  • Lyophilization cycle development
  • Stability on process intermediates and process hold steps
  • Determination of Critical Quality Attributes (CQAs) and Critical Process Parameter (CPPs) validation

We have years of experience in characterization and supporting the selection of the best candidates for progressing to clinical studies.

Early candidates can be produced from different antibodies, types of linkers and payloads to screen for the most potent solution for your target.

Material generated is used to develop your early-stage material for analytical and formulation development.

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Stability

Offering a full spectrum of services, we support stability for drug substance, drug product 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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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 mitigations strategies to ensure your overall success in delivering vital medicines to patients safely.