Why early lead optimisation is holding back biotech and how our new whitepaper can help
- Ellie Gadd
- 11 minutes ago
- 2 min read
Early-stage biotech development has never been more complex. With pressure to move
faster, demonstrate robust data earlier, and meet rising regulatory expectations, many teams struggle during one of the most critical phases of the journey: lead optimisation.
Today, 3Biotech is pleased to introduce our new whitepaper, Strategic Lead Optimisation
and Selection, which explores how early CMC insight can transform development outcomes and reduce risk for small and mid-sized biotech companies. The paper is available now as a free download.
Why lead optimisation remains a major challenge for biotech
Many early-stage programmes encounter issues that slow progress long before IND or IMPD preparation begins. Common challenges include:
Stability issues emerging late in development
Unscalable synthesis routes that drive up cost of goods
Incomplete analytical characterisation, leading to regulator questions
Manufacturability concerns for biologics, peptides and mRNA therapeutics
These issues often arise because CMC considerations are introduced too late—something the whitepaper examines in depth.
How early CMC insight changes the development trajectory
The new whitepaper highlights how early CMC planning offers a more predictable and
efficient path forward. Key themes include:
Parallel development to accelerate progress Running analytical, formulation and process development activities in parallel can reduce timelines by months while maintaining scientific quality.
Stronger decision-making frameworks
Using structured evaluation criteria, including manufacturability scoring and early risk assessment, helps teams prioritise the right candidates from the outset.
Greater regulatory and investor confidence
Well-defined CMC plans signal maturity and readiness, supporting both regulatory
interactions and investment discussions.
Insights for biologics, small molecules and complex modalities
Modern biotech development spans diverse therapeutic formats, each with unique risks. The whitepaper explores:
aggregation and immunogenicity challenges in biologics
manufacturability and route optimisation for small molecules
modality-specific risks in mRNA, peptides and ADCs
It also includes a detailed case study demonstrating how a structured CMC-led framework accelerated lead selection for a bispecific oncology candidate.
Who will benefit from reading this whitepaper
The content is designed for:
early-stage biotech teams navigating translational development
scientific leaders seeking improved decision-making tools
project managers working towards IND/IMPD readiness
companies developing biologics, bispecifics, peptides, ADCs or other complex
modalities
Whether your challenge is analytical readiness, manufacturability, regulatory alignment or cross-functional decision-making, the insights are directly applicable.
Download the full whitepaper
The complete whitepaper offers practical frameworks, evaluation tools and real-world examples to help biotech teams optimise lead selection and reduce development risk.
At 3Biotech, we support organisations through every stage of development, from early CMC risk assessment to regulatory submissions and CDMO management. This whitepaper is part of our ongoing commitment to helping biotech innovators accelerate progress with clarity and confidence.
For more useful tools and resources designed specifically for early-stage biotech teams, visit our resources section.
