Science and

TKD Soultions helps streamline both internal and contracted manufacturing. We can identify the right manufacturer, provide CDMO management on your behalf, and ensure that the right oversight is in place to enable program success.

Bringing a program from bench to bedside requires stringent manufacturing practices. MS&T utilizes the Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) identified during process development along with Critical Material Attributes (CMAs) to build a lean manufacturing process that scales to satisfy regulatory guidelines as well as clinical trial demand.

Late-stage manufacturing requirements for clinical supply should be considered early in the program lifecycle to mitigate risk. We assess the Chemistry, Manufacturing and Controls (CMC) and Good Manufacturing Practice (GMP) requirements for your program with early and regular quality assurance reviews ensure to streamlined, de-risked manufacturing.

  • On-Site Manufacturing Support
  • CDMO management
  • Batch Record authoring & review SOP authoring
  • Site Selection
  • Statistical Process Controls
  • Supply Chain
  • Quality Assurance
  • Process Validation
  • Chemistry, Manufacturing and Controls (CMC)
  • Good Manufacturing Process (GMP)

TKD Solutions has extensive experience managing MS&T for gene therapies, biologics and cell therapies. We are well-versed with the requirements for plasmid DNA manufacturing from cell expansion to final fill and finish.

We can recommend GMP raw materials, single-use fermentation processes and GMP master and working cell bank development and maintenance strategies among other services for gene and cell therapies. We can also support the complete biologic manufacturing process from upstream bioreactor support all the way through to bioburden and aggregate removal.

TKD can support MS&T for your internal manufacturing with your team or external manufacturing with your hired CDMO. We have experience working with many different CDMOs and can identify a CDMO that meets your needs. We ensure that the right oversight is in place to enable your program’s success.

Learn how we can support your current and future manufacturing needs.

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