Our Expertise

At TKD Solutions, our team is comprised of scientific experts who have lived through the complexities of nonclinical development and CMC at both small and large organizations. It is with that understanding that we seek to be the support we wish we had for your gene therapy, cell therapy, or biologic in development.

Gene Therapies

Gene therapies encompass a complex set of therapeutics with many different formulations and mechanisms of action. The therapy may be engineered to replace or inactivate a disease-associated gene or introduce a gene; and the formulation may include plasmid DNA, viral vectors, bacterial vectors, or lipid nanoparticle formulations.

With the wide-reaching MOAs and formulations, gene therapies are an exciting frontier in biotechnology with a growing market; but as with any new technology, gene therapy development presents process unknowns, evolving regulatory requirements, and limited personnel with expertise in this field. As such, the process of choosing a candidate gene therapy, formulation and scalable process can be daunting and requires many different areas of expertise which TKD Solutions can provide.

TKD Solutions has expertise in the many different types of gene therapies including Adeno-Associated Virus (AAV), Lentivirus, and Adenoviral Vector. We have extensive experience in target and lead discovery using isoform analysis, expression screening and functional characterization. As your gene therapy program evolves, we can use our experience to guide formulations and manufacturing processes based on final product requirements. Our experience has included host cell screening, stable and transient transfections, expression and titer optimization.

We have also done downstream analysis including serotyping and capsid assembly, protein expression and transgene activity, genetic load, and mRNA expression in tissue; and we have developed biomarkers that can help demonstrate the activity of the gene therapy in nonclinical and clinical settings. TKD Solutions understands the diverse and evolving nature of gene therapies, and we have a team of experts who have the expertise required to address the many types of gene therapies and the unique development needs of each gene therapy.

Cell Therapies

Cell therapies are providing potential solutions to previously incurable diseases. From stem cells and regenerative medicine to CAR-T cells and oncology therapeutics, the possibilities are seemingly endless for cell therapy applications. Cell therapies may include induced pluripotent stem cells (iPSCs), Natural Killers (NKs), Tumor Infiltrating Lymphocytes (TILs), and CAR-Ts to name a few.

Along with the many exciting indications and various engineered cell lines, cell therapies bring many nuances to traditional cell line development and regulatory requirements. Each cell line requires its own development process including unique raw materials, culture and transfection conditions, and differentiation methods for iPSCs. Understanding the cell line development and scale-up requirements of first-in-class, engineered lines can be a challenging task; and TKD has the expertise required to advise your cell therapy program as it moves from bench to clinic.

TKD Solutions has extensive experience in the development and manufacturing of cell therapies. We can provide guidance on early stage transient and stable transfections, clone selection, master cell banking and culture conditions. As your cell therapy matures, we can share our expertise in scale-up and bioreactor conditions; and we can propose the appropriate methods for downstream analytics of phenotyping and cell markers.

To ensure a smooth transition to clinical studies, we have experience in the regulatory requirements for cell therapies, and we can advise on early phase toxicology study design as well as the appropriate supply chain for cellular therapies reaching the clinic. Cell therapies include an expansive array of cell types and cell line development, and TKD can provide the experience required to address the cell line-specific challenges of bringing a cell therapy to market.


While FDA-approved biologics have been on the market for several decades, the industry continues to see new types of biologics introduced to pharmaceutical pipelines including fusion protein, bispecifics, and novel classes of proteins derived from unique sources. With each new type of recombinant protein and vaccine, new processes must be developed to account for unique expression and purification systems, scale-up and downstream analytics.

Along with process development, regulatory requirements must be determined and addressed for classes of proteins that, in many cases, have no prior regulatory guidance. TKD Solutions has experience with a broad range of biologics, and we can help address the unique needs of each novel biologic.

TKD Solutions has experts who led many biologics programs, and we are able to provide customized support to your unique biologic. For early stage development, we have experience in choosing candidate clones and designing mechanism of action studies.

We can also assess drug targets and provide drug purposing study design. As the biologic transitions from pre-clinical to clinical studies, TKD Solutions can support scale-up and process development.

We have experience choosing producer cell lines and optimizing cell line development for scale in bioreactors. We can also advise optimal purification workflows and downstream analytics such as titer, purity, potency, binding, intact mass and glycan analysis.

As the product continues to advance, we can advise on clinical study design, efficacy and safety studies, and regulatory guidance for your team’s biologic. Biologics continue to require new and varied support as the engineering and formulations advance, and TKD Solutions has the experience to advise your most complex biologic programs.

Learn more about the comprehensive services we offer for the development of gene therapies, cell therapies, and biologics.