‘Biopharma innovators must widen CDMO networks to accelerate development’ says Shilpa Biologicals CEO ahead of BIO San Diego
Too many biotechs rely too narrowly on large CDMOs and engage too late, increasing risk of delays, scope creep and cost overruns by up to 40%
27th May, 2026: Ahead of next month’s BIO San Diego, Shilpa Biologicals Director Madhav Bhutada has urged biotechs to take a broader and earlier approach to CDMO selection as funding conditions improve across the sector.
He argues that many emerging biopharma innovators – particularly those developing more complex modalities such as bispecific and trispecific antibodies – continue to rely heavily on a small number of well-known large CDMOs. Bhutada said biotechs frequently underestimate the operational constraints of large-scale CDMOs, particularly around capacity allocation and managing changes outside agreed scope.
While many companies are aware that manufacturing slots are limited and that additional costs may arise, they still often default to the largest providers early in the process. This can lead to avoidable inefficiencies. Projects that exceed defined scope can incur significant additional charges, while delays in securing alternative manufacturing slots may further extend development timelines. Shilpa Biologicals estimates that overruns add 20–40% to budgets in some cases and materially delay entry into clinical trials. The issue is particularly evident among biotech teams spun out of big pharma environments, where expectations of service levels can carry over despite now operating as a biotech start-up within a much larger CDMO client base.
“Too often, a biotech operating on a tight budget assumes a perfect manufacturing scenario with no challenges,” Bhutada said. “This is where problems begin.”
Early-stage planning around scope definition and out-of-scope work is therefore increasingly important, as unforeseen changes remain a common driver of both delay and budget pressure in biologics development programmes. In practical terms, working with a smaller CDMO partner can shorten the path from discovery to clinic by several months. While timelines at the largest CDMOs may, in ideal scenarios, be only around six months, in practice 12 months is often more realistic once issues arise. By contrast, smaller CDMOs will often complete comparable work in around six to nine months, typically at lower costs, as they are able to provide a dedicated team of scientists specifically focused on rapid troubleshooting.
This shift towards more diversified CDMO strategies is also increasingly reflected across the wider industry, with even CMC consultants and investors now placing greater emphasis on CDMO selection and network design during due diligence. Bhutada said this shift in mindset is becoming increasingly important as programmes progress towards clinical milestones, where delays can have significant commercial implications.
“I cannot stress this enough – particularly when getting into the clinic and ultimately phase ii, which is where companies are made or broken,” he said. “It is not only cost, but time lost, that is critical to long-term commercial viability. So I predict you will see both VCs and consultants at BIO now factoring this into their decision-making triage on biotech investments.”
---ENDS---
About Shilpa Biologicals Pvt Ltd
Shilpa Biologicals, part of the Shilpa Medicare Group, is a global biopharmaceutical company with end-to-end capabilities in biologics discovery, development, and manufacturing, focused on building a pipeline of innovative and globally competitive biologics.