Biologics Process Development

Seamless biologics process development, optimization and manufacturing from Cell Line Development (CLD) to patient.

Minimize risk, timelines and costs.

Applying decades of experience, Abzena have expertise across across multiple modalities, which means we can successfully transfer your existing process, or develop new, innovative processes to meet your objectives. Our strategy minimizes risk, timelines and costs.

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

Our process development, optimization and manufacturing teams work together to develop quality, commercially viable processes, that ensure a seamless scale up directly from bench scale to final manufacturing through to commercialization.

Our state-of-the-art locations have a range of capabilities supporting the development, scale-up, optimization and stability of your process.

Our Process Development Capabilities

Development capabilities include:

  • Experience with multiple mammalian cell types including CHO, ABZ-CHO K-1, sp2/0, yp2/0, and NSO
  • Experience beyond mAbs including fabs, ADCs, oligonucleotides, nanoparticles, bispecifics, fusion proteins, vaccines, virus-like particles, enzymes, and bioconjugates
  • Transfer verification optimization of your process
  • Design of statistical experiments to optimize media feeds and growth conditions
  • Scale down fed batch and perfusion production models
  • Robotic systems from 250ml to manufacturing scale at 2K
  • High cell density and titer optimization
  • Bench scale process characterization and validation
  • Coordination with Analytical Method Development (AMD) to determine quality attributes

Optimizing your downstream processes

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 include:

  • 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

 

Commercial Manufacturing

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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Let’s move medicine forward.

The treatments you’re developing right now can make a real difference for human health. Let us support your work by successfully transferring an existing process—or developing a new one designed around your exact needs.