Clinical - CMC Bioanalytical
We excel in the biological characterisation of large molecule and advanced therapeutics, providing expert assay design for product characterisation, lot release, stability assessments, and clinical support with robust data analysis and regulatory compliance.
Ensure consistent, efficacious and safe production of your therapeutic products
We focus on product characterisation, involving the development and validation of controlled methods for GMP lot release, stability programmes and extended characterisation while establishing release specifications for therapeutics and biosimilarity assessments.
Methodology
Selecting the right methodologies is a critical step in the development of therapeutic modalities. It requires a comprehensive understanding of your therapeutic’s biology, its performance across a battery of pre-clinical assay formats and the knowledge of performance characteristics needed for clinical manufacture.
Phase Appropriate Solutions
With a unique blend of scientific expertise from translational research through to rigorous bioanalytical methodologies, we offer flexible, phase-appropriate solutions. Our cross-functional team provide unparalleled expertise in potency assay development through a collaborative approach, providing tailored support and insights across selection, development and validation phases. With integrated services including custom cell line development, we establish novel potency assay formats across a variety of platforms including cell-based assays, ELISA or SPR.
Approval
Our commitment to scientific excellence and innovation ensures that we deliver high-quality, actionable results that support successful manufacturing and regulatory approval. Challenges inspire us - share yours, and we’ll deliver the solution.
Propel drug discovery breakthroughs with RoukenBio
Difficulty doesn’t deter us; it inspires us. Give us a problem, and we’ll find your solution. Our versatile specialists embrace every obstacle as an opportunity to showcase our innovative thinking and problem-solving prowess.
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