GREAT WORK THAT
MOVES THE PROGRAM
WHAT WE DO
All the capabilities you need, in one place
Protein Conjugation
Engineered for function
-
Selection and optimization of conjugation chemistry for peptide and protein targeting vectors
-
Define chelate-to-protein ratio and product characterization
-
Evaluation of stability, binding affinity, and functional integrity post-conjugation
-
Development of scalable, reproducible conjugation workflows suitable for preclinical or regulated environments
-
Technical oversight of internal or external bioconjugation activities
IND Enabling Studies
Focus execution of data generation
-
Assessment of product readiness for clinical entry, from preclincial data set to manufacturability of the drug product relative to first-in-human requirements
-
Define the development path to human use, including identification of critical data gaps, risk mitigation strategies, and the studies required to support regulatory authorization
-
Coordination with CRO's and internal teams to ensure operational efficiency and quality
Radiochemistry
Reliable, repeatable and robust
-
Development and optimization of radiolabeling methods for all isotopes
-
Establishment of robust, reproducible synthesis and purification workflows
-
Stability assessment and formulation optimization for in-vivo studies
-
Transfer of methods to GMP manufacturing environments or external CDMOs
-
Troubleshooting of radiolabeling efficiency, radiochemical purity, and product consistency
CMC
Quality, speed, cost: optimized
-
Establish the critical quality attributes and product specifications
-
Development of manufacturing workflows for clinical-stage material of precursor and final drug product
-
Analytical method selection, qualification, and validation planning
-
Preparation and review of CMC documentation for regulatory submissions
-
Technical oversight of CDMO's and manufacturing partners
Preclinical Studies
Data-driven insights
-
Study design for biodistribution, pharmacokinetics, and target engagement
-
Model selection and experimental planning aligned with preclinical/clinical objectives
-
In-vitro assay development to characterize binding, internalization, and functional performance
-
Design and optimization of immunoreactive fraction assays to quantify functional binding following radiolabeling
-
Data analysis and interpretation to support go/no-go decisions
Regulatory Approach
Strategic guidance
-
Development of integrated regulatory and development strategies
-
Preparation and review of briefing packages and regulatory submissions
-
Alignment of preclinical and CMC activities with regulatory expectations
-
Identification of key risks, decision points, and program dependencies
-
Representation of the program in technical and regulatory discussions