Cell & Gene Therapy Services

The cell and gene therapy (CGT) industry is nothing if not dynamic, with transformative potential for treating genetic disorders, cancer, and previously untreatable conditions. Amazing science is being implemented on a daily basis across hundreds of cell and gene therapy innovator companies and organizations. However, as the industry is in a nascent stage of commercialization, there are no manufacturing “platforms” yet established…which leads to a hodge-podge of processes and analytics which add significant costs across the process development, analytical development, and scale-up panorama. 

TKD Solutions helps to solve these myriad problems by applying our specific know-how – and hence, clarity – as a pivotal service partner for CGT developers. Our tailored services are designed to accelerate your CGT product development and commercialization while saving you six-to seven-figure dollars with optimized process and analytical platforms.

A Comprehensive Service Portfolio for CGT Developers and Manufacturers

We guide our clients through every stage of the development process, with consultants whose expertise covers everything from nonclinical studies to commercialization of your therapy.

Our offerings include:

1. Process Development: TKD optimizes both upstream and downstream processes, focusing on scalability, efficiency, and regulatory compliance. This includes cell line development, purification, viral clearance, and process validation, ensuring that CGT projects transition seamlessly from lab-scale research to clinical manufacturing​.
   
2. Analytical Development: Our analytical services focus on designing, validating, and transferring robust testing methods. This expertise supports quality control and regulatory filings critical for advancing products through clinical stages​.
   
3. Regulatory Affairs and CMC Support: TKD helps navigate the evolving regulatory landscape for CGTs and biologics, ensuring compliance with stringent requirements to mitigate risks and avoid delays​.
   
4. Manufacturing Science and Technology: We provide guidance on scale-up, bioreactor conditions, and downstream analytics with an aim to “design for manufacturability,” crucial for successful transition to clinical production​.
   
5. Cross-Departmental and Vendor Collaboration: Acting as an extension of your internal team, we can take the reins and facilitate seamless interaction with your vendors, CROs, and CDMOs to streamline project execution​, freeing you to focus on the business of managing your business and stakeholders.

Specialized Expertise in Advanced Therapies

Our team at TKD Solutions brings deep CGT knowledge from our range of experiences at small biotech to Big Pharma; we bring that experience to bear while helping you solve the nuanced challenges in CGT development:

• Gene Therapies: Our expertise spans viral vectors like AAV and lentivirus, optimizing expression systems, and addressing analytical challenges like transgene activity and capsid assembly​
  
• Cell Therapies: Our capabilities include supporting CAR-T development, iPSCs, and other cell types with tailored culture, transfection, and differentiation methods​

TKD Solutions brings deep CGT knowledge from our range of experiences at small biotech to big pharma

Collaborative and Agile Approach

What sets TKD Solutions apart is our ability to integrate deeply with our clients’ teams, providing both technical know-how and collaborative support. This model ensures that projects are executed efficiently and with a high level of quality, minimizing time-to-market​. We are a trusted partner for developers navigating the intricate pathways of cell and gene therapy.

Our focus on quality, efficiency, and collaboration positions them as an invaluable ally in bringing life-changing therapies to patients faster and more effectively.