The advanced therapies of tomorrow are complex and require equally complex production processes. Both upstream and downstream processes can affect production time, cost and scalability of product. As such, developing optimized processes early in the CGT or biologic development timeline is crucial to the success of any biotechnology campaign.

We optimize your process by holistically contemplating process efficiency, regulatory requirements, and product quality. In the end, the process must balance these parameters to result in an economically sustainable process that will meet future market demands of your advanced therapy.

We believe that quality assurance is an inherent part of the process development effort. Regulatory requirements and final product specifications will guide much of the process development throughout the lifecycle of the program. Understanding the critical quality attributes (CQAs) and critical process parameters (CPPs) can be leveraged with regulatory guidance to develop an optimized process.

We de-risk the process early to prevent challenges regarding CMC (chemistry, manufacturing, and controls) submissions in late-stage programs. Other challenges such as scale-up, supply chain and meeting clinical trial timelines can be mitigated by becoming compliant early in the product lifecycle. Effective quality assurance of the process development will prevent costly corrective actions in late-stage programs.

  • Upstream Process 
    • Cell line development
    • Media/feed optimization
    • Scale-up
  • Downstream Process 
    • Harvest, purification, viral clearance
    • Formulation
    • Process improvement
    • Process validation
    • Process characterization
  • General Process Development 
    • Quality by Design (QbD)
    • Development reports
    • Design of Experiments (DOE)
    • Tech transfers
    • Troubleshooting
    • Quality Assurance
    • Technology and Facility Evaluations

Our experts at TKD Solutions have experience in both upstream and downstream process development to help your team reach the optimal process performance. TKD understands the many delicate nuances involved in process development of gene therapies, biologics and cell therapies.

We know that scale-up is never as simple as increasing volume, and we guide your team on decisions such as cell adaptation, outgassing and transfection reagents for optimal production of complex products that may include mAbs, viral vectors, AAVs and LVVs while being mindful of regulatory requirements and product stability.

With TKD’s guidance, your process can be optimized and compliant early in your program to streamline your path to approval.

Connect with one of our Process Development experts.

Nonclinical / Early Phase Development Process Development Regulatory Affairs Cross-Departmental Support Analytical Development Project Management Manufacturing Science & Technology Nonclinical / Early Phase Development Process Development Manufacturing Science & Technology Analytical Development Project Management Regulatory Affairs Cross-Departmental Support