Biopharma firms must diversify CDMO partnerships to avoid costly delays: Shilpa Biologicals MD

Madhav Bhutada says overdependence on large CDMOs and delayed engagement can increase development costs by up to 40% and slow clinical progress

Shilpa Biologicals Director Madhav Bhutada has called on biotech companies to adopt a broader and earlier strategy for selecting CDMO partners as funding activity begins to improve across the biopharma sector.

Ahead of next month’s BIO International Convention 2026, Bhutada noted that many emerging biopharma innovators, especially those working on advanced modalities such as bispecific and trispecific antibodies, continue to depend heavily on a limited pool of large, established CDMOs.

According to him, biotech firms often underestimate the operational limitations associated with large-scale CDMOs, particularly around manufacturing capacity allocation and handling work that falls outside predefined project scope.

Although companies are generally aware of long wait times and potential cost escalations, many still prioritise larger CDMOs at the early stages of development. This, he said, frequently leads to avoidable inefficiencies. Projects that move beyond agreed scope often attract substantial additional costs, while delays in securing alternate manufacturing slots can significantly extend development timelines. 

Bhutada added that the issue is particularly common among biotech teams spun out of large pharmaceutical organisations, where expectations around service responsiveness and operational flexibility may not align with the realities of operating as a smaller client within a major CDMO network.

“Too often, a biotech operating on a tight budget assumes a perfect manufacturing scenario with no challenges,” Bhutada said. “This is where problems begin.”

He emphasised that early-stage planning around project scope and out-of-scope activities has become increasingly important, as unexpected changes continue to be a major contributor to delays and budget pressures in biologics development.

Bhutada further pointed out that smaller CDMO partners can often help accelerate the journey from discovery to clinic.

"While large CDMOs may theoretically offer timelines of around six months, practical execution frequently stretches closer to 12 months once operational hurdles emerge. In contrast, smaller CDMOs are often able to complete similar work within six to nine months at comparatively lower costs, largely due to more dedicated scientific teams and faster troubleshooting capabilities."

He added that this evolving mindset is becoming critical as biotech programmes approach clinical milestones, where delays can carry significant commercial consequences.

 “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.”