Shilpa Biologics targets global ADC partnerships as it prepares GMP facility launch at US BIO 2025

June 20, 2025 | Friday | News | By Manasee Kurlekar

As the global ADC market grows, Shilpa Biologics is emerging as a serious player from India with an integrated platform and a new 200-litre GMP facility while seeking partners to expand into the US and Europe through regulatory and clinical collaboration

As the global antibody-drug conjugate (ADC) market expands — driven by both new therapeutic approvals and growing pipelines — manufacturing expertise is becoming a critical differentiator. At US BIO 2025, BioSpectrum spoke with Shilpa Biologics about their ambitions and their search for the right global partners.

Shilpa Biologics, part of India’s growing biomanufacturing landscape, is commissioning its 200-litre GMP ADC conjugation facility, with first GMP batches scheduled for late 2025. The company’s integrated offering includes:

  • Payload and linker production (CDMO services active today)
  • FDA-approved high potent API manufacturing suites
  • Monoclonal antibody production capabilities
  • An advancing pipeline targeting HER2, HER3, and TROP2

In conversation with BioSpectrum, Shilpa leadership emphasized that while their technical and manufacturing base is strong, strategic partnerships will be key to expand globally, particularly in navigating the complex regulatory pathways for biosimilar ADCs in the US and Europe.

The company is also leveraging India’s AI-driven biotech ecosystem, partnering with Bangalore-based startups to accelerate process development and optimize molecule design — further enhancing its value proposition for potential collaborators.

"Our strength is in manufacturing precision and scalable execution," a Shilpa executive tells BioSpectrum. "But we are looking for partners who bring complementary strengths: clinical expertise, regulatory experience in mature markets, and commercial pathways."

At a time when large pharma companies are increasingly looking for reliable ADC manufacturing partners with both capacity and technical depth, Shilpa Biologics is positioning itself as a serious contender from India’s advancing life sciences sector.

 

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