Rakestraw Biotech Consulting Services

Expert guidance in drug discovery, protein engineering, and cell therapies for biotech and pharma companies.

Specialized in high-throughput platforms, library design, and next-generation engineering:

• Protein engineering strategies and high-throughput display systems

• Antibody and protein library design and screening approaches

• Antibody discovery, optimization, and humanization

• Cytokine engineering for function and expression

• Engineering T-cell and B-cell agonists for function and solubility

• Engineering CAR and receptors for specificity and altered function

• Assay development for candidate screening and IND

Providing support for research, manufacturing, & regulatory functions in B- and T-cell therapies:

• Research and early development for T- and B-cell therapies

• Methods for ex vivo cell culture, training, and phenotype engineering

• Analytic development in cell therapy for pre-clinical and GMP

• Applied T- and B-cell engineering

• Gene-editing with CRISPR and AAV

• Analytic support for gene-edited cells

• CMC team-building, strategy and bulidout

• CDMO and CRO management

Empowerment with strategy and support from discovery to the clinic:

• Design and implementation of potency assays for IND and GMP manufacturing

• pre-IND and IND authorship and FDA interactions

• CMC strategy for IND and Phase I manufacturing

• CDMO/CRO vetting, engagement, and management

• Pre-clinical report writing for Module 4

• Studies for mechanism of action

• Dose calculations

• Biologic and cell therapy study design

• Module 3 IND Authorship

Pre-Clinical and IND Strategy