The importance of process development (PD) for first-time right manufacturing for clinical study 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.
Process Development for Flawless GMP Execution
Process Development
- • Begin with a knowledge transfer of your existing process, or the development of a 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.
- • Our PD and cGMP manufacturing teams closely collaborate and are cross trained to ensure process performance and quality. CBM’s pilot plant enables GMP-scale manufacturing in a non-GMP environment to work out any kinks.
Viral Vector Development
Upstream Drug Substance
- • 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, optimization, and characterization
Downstream Drug Stance
- • Viral vector purification capabilities across all processing steps: filtration, chromatography, and ultracentrifugation
- • Process development, optimization, and characterization
Drug Product & Analytics
- • High-throughput formulation development
- • Drug product process development and characterization
- • Compatibility, stability, and force-degradation studies
Cell Therapy Development
Drug Substance
- • Process scale-up (allogeneic) and scale-out (autologous)
- • Process development and optimization for early phase trials
- • Reduction of process length through optimization of activation, transduction, and harvest
- • Process closure and automation
- • Process characterization and validation as BLA-enabling activities
- • Technology transfer and Pilot production to for all phases
- • Technology transfer / GMP readiness
Drug Product
- • Development of small and large scale harvest and formulation steps
- • Formulation & fill process automation and closure
- • Development of cryopreservation cycle for bagged and vialed drug product presentations at various scales
- • Container closure development
- • Pharmacy manual studies in support of clinical and commercial administration
Preclinical Studies
Enabling Preclinical Development
- • IND-enabling pre-clinical package delivers end-to-end support for pre-clinical studies and includes off-the-shelf AAV rep-cap and helper plasmids, custom plasmid manufacturing, access to a proprietary cell line, streamlined process development services, scalable pre-clinical vector manufacturing services as well as regulatory support for INTERACT and Pre-IND meetings.
- • This package enables therapeutic developers to generate high quality material and data in under five months and positions them to move rapidly towards IND approval and GMP clinical manufacturing.
- • Holistic pre-clinical offerings will supply drug substance and drug product for proof-of-concept, toxicology, safety, biodistribution studies, method development, interim reference standard, development stability, and drug product development critical for IND packages. These productions utilize similar processing techniques as would be used for GMP manufacturing, eliminating comparability risks associated with process changes.
- • Additional analytical testing and regulatory services are available to prepare data briefing packages for INTERACT and Pre-IND meetings.
- • Upon pre-clinical manufacturing completion, clients have full transparency to the data from execution, production, and purification, a critical data set for the sponsor of any clinical program
- Process Development Strategy
-
Process Development
- • Begin with a knowledge transfer of your existing process, or the development of a 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.
- • Our PD and cGMP manufacturing teams closely collaborate and are cross trained to ensure process performance and quality. CBM’s pilot plant enables GMP-scale manufacturing in a non-GMP environment to work out any kinks.
- Viral Vector Development
-
Viral Vector Development
Upstream Drug Substance
- • 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, optimization, and characterization
Downstream Drug Stance
- • Viral vector purification capabilities across all processing steps: filtration, chromatography, and ultracentrifugation
- • Process development, optimization, and characterization
Drug Product & Analytics
- • High-throughput formulation development
- • Drug product process development and characterization
- • Compatibility, stability, and force-degradation studies
- Cell Therapy Development
-
Cell Therapy Development
Drug Substance
- • Process scale-up (allogeneic) and scale-out (autologous)
- • Process development and optimization for early phase trials
- • Reduction of process length through optimization of activation, transduction, and harvest
- • Process closure and automation
- • Process characterization and validation as BLA-enabling activities
- • Technology transfer and Pilot production to for all phases
- • Technology transfer / GMP readiness
Drug Product
- • Development of small and large scale harvest and formulation steps
- • Formulation & fill process automation and closure
- • Development of cryopreservation cycle for bagged and vialed drug product presentations at various scales
- • Container closure development
- • Pharmacy manual studies in support of clinical and commercial administration
- Preclinical Studies
-
Preclinical Studies
Enabling Preclinical Development
- • IND-enabling pre-clinical package delivers end-to-end support for pre-clinical studies and includes off-the-shelf AAV rep-cap and helper plasmids, custom plasmid manufacturing, access to a proprietary cell line, streamlined process development services, scalable pre-clinical vector manufacturing services as well as regulatory support for INTERACT and Pre-IND meetings.
- • This package enables therapeutic developers to generate high quality material and data in under five months and positions them to move rapidly towards IND approval and GMP clinical manufacturing.
- • Holistic pre-clinical offerings will supply drug substance and drug product for proof-of-concept, toxicology, safety, biodistribution studies, method development, interim reference standard, development stability, and drug product development critical for IND packages. These productions utilize similar processing techniques as would be used for GMP manufacturing, eliminating comparability risks associated with process changes.
- • Additional analytical testing and regulatory services are available to prepare data briefing packages for INTERACT and Pre-IND meetings.
- • Upon pre-clinical manufacturing completion, clients have full transparency to the data from execution, production, and purification, a critical data set for the sponsor of any clinical program
Related Thought Leadership
White Paper: Process Platforms vs. Custom Process Development for AAVs and Gene Therapies
Transform Your Clinical Development
Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The results? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
CBM Expertise
CBM is an advanced therapy CDMO dedicated to developing life-changing treatments to our customers. We offer unapparelled flexibility to work alongside our subject matter experts in development labs and GMP operations in our manufacturing suites.
Our Process Development team has deep expertise in building and optimizing processes for cell and gene therapies for seamless transfer to GMP manufacturing. We’re willing to put skin in the game with flexible capacity usage and milestone-based arrangements.