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Process Development

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The importance of first-time right process development (PD), whether for preclinical studies or for scale-up and commercial readiness, cannot be overstated. It is critical to increasing yields, achieving product quality expectations, and lowering the cost of goods while meeting clinical development and commercial readiness milestones. We offer phase appropriate process development support from preclinical, to clinical and commercial.

The Center for Breakthrough Medicines (CBM) has a PD team with unrivaled experience building and optimizing biopharmaceutical processes for early-stage, clinical and commercial advanced therapies.

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Strategic development drives flawless GMP execution

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Developing Strategy

Our process begins with a knowledge transfer of your existing process, or the development of a de novo custom bioprocess from scratch. Our PD team then develops an optimal strategy to develop processes that generate quality material for IND-enabling studies and align equipment with future pilot scale and cGMP-scale operations.

Implementing Strategy

Our plasmid manufacturing, viral vector, and cell therapy process platforms are fully scalable. The generation of high-quality drug product and data is critical for every stage of development. Our processes are designed to meet safety, quality, and yield expectations and are scalable to phase-appropriate production volumes while maintaining critical quality attributes (CQAs) throughout the product lifecycle to commercialization. Our capabilities create high throughput production with low volume requirements – designed to reduce study times by up to 3X.

Technology Transfer

Our PD and cGMP manufacturing teams closely collaborate and are cross-trained to ensure process performance and quality. CBM’s pilot plant enables GMP manufacturing at smaller scale to work out any kinks. From here, we seamlessly transfer your manufacturing process and scale up with pilot and training runs in one location to advance your project to cGMP production. Additional regulatory services are available to prepare data briefing packages for INTERACT and Pre-IND meetings.
Learn about CBM’s Analytical Development & Testing >

Viral Vector Process Development

Upstream

  • Suspension and adherent manufacturing platforms for Adeno-Associated Virus (AAV), Adenovirus, Lentivirus, and other novel viral vectors
  • Research cell and virus banking (RCB & RVB)
  • Process development - de novo or review of current process
  • Pilot production to support IND-enabling studies

Downstream

  • Viral vector purification capabilities across all processing steps: filtration, chromatography, and ultracentrifugation
  • Process development - mitigation of scaling impact risk (yield, impurities)
  • Process validation / BLA-enabling activities
  • Pilot production to support IND-enabling studies

Drug Product & Analytics

  • High-throughput formulation development
  • Drug product process development
  • Drug product characterization
  • Stability and force-degradation studies

Preclinical Manufacturing

  • R&D plasmid manufacturing
  • Access to proprietary cell line
  • Streamlined process studies
  • Preclinical vector manufacturing
Learn about CBM’s Viral Vector Capabilities >

Cell Therapy Process Development

Drug Substance

  • Process development and characterization for both autologous and allogeneic products
  • Process validation / BLA-enabling activities
  • Pilot production to support IND-enabling studies
  • Technology transfer / GMP readiness

Drug Product

  • Formulation development
  • Formulation & fill process automation and closure
  • Cryopreservation cycle development
  • Container closure development
Learn about CBM’s Cell Therapy Capabilities >