Where and how an asset is made is now part of what it is worth. Z2 provides independent scientific and CMC due diligence for investors, funders and strategic partners evaluating biologics technologies, development programmes and upstream manufacturing potential – so red flags are found before you commit.
Each review is evidence-based: it assesses scientific validity, technical maturity, scalability, development risk and value potential, to support investment, partnership, acquisition or programme-progression decisions.
What Z2 assesses
- Technology maturity: is the science real, and how far has it been taken?
- Proof-of-concept evidence and data maturity
- Scalability: does the process survive manufacturing scale?
- Development risk: capability gaps and unproven assumptions
- CMC readiness, including IND/BLA documentation, with FDA and MHRA experience
- CDMO and supply-chain position, including exposure under the BIOSECURE Act
Why CMC diligence matters now
Manufacturing problems now outrank efficacy as the main reason the FDA rejects a filing, and UK biotech capital has become more selective.
74%
of FDA rejection letters issued 2020–2024 cited quality or manufacturing (CMC) deficiencies1
1.3 years
median delay from rejection letter to eventual approval2
−48%
fall in UK biotech venture deals in 2025 (111 → 58)3
£2.6B
UK biotech VC in H1 2026, led by Isomorphic Labs4
Under the US BIOSECURE Act, signed in December 2025, supply chains have become a diligence item: when a supplier is restricted, buyers ask whether the process can move – and the answer needs CMC review.5
Where rushed timelines break
Diligence reads CMC summaries, not raw data – and few deal teams can judge whether a process can move sites.1
Where Z2 helps
A data-room review of clone, process and CDMO, with a red-flag report.
Sources
- Pharmaceutical Technology. CMC and analytical gaps in CRLs: why they persist despite FDA guidance, July 2026.
- Deficiencies Delaying Prescription Drug Approvals by the US FDA, 2020–2024. PubMed 41670800, 2026.
- BioIndustry Association. UK biotech financing 2025, Jan 2026.
- BIA / Biotech Finance. UK biotech financing Q2 2026.
- BIOSECURE Act: Arnold & Porter, Dec 2025; FDA Law Blog, Jun 2026; Zenas BioPharma 10-K FY2025.
