Whitepaper

Why speed and flexibility matter now more than ever

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Posted: 20 October 2025 | | No comments yet

The balance between speed, scale, and compliance has never been more critical. As GLP-1s, biosimilars, and advanced therapies reshape global priorities, pharma leaders face a new question: how can manufacturing infrastructure evolve fast enough to keep pace?

The pharmaceutical industry is at a turning point. After years of moving toward specialized, small-batch therapies, the explosive rise of GLP-1s, biosimilars, and vaccines has reignited the need for large-scale, high-quality manufacturing. Yet, finding a CDMO partner that combines speed, flexibility, and unwavering compliance is more difficult than ever.

This whitepaper explores how forward-thinking CDMOs are transforming their operations to meet today’s demanding environment — and how ROIS is leading the way.

Key insights you’ll discover

  • From niche to scale: How the GLP-1 boom is reshaping pharma manufacturing priorities
  • The new compliance challenge: What evolving GMP standards – including Annex 1 revisions – mean for sterile production.
  • Bridging speed and scale: Why most CDMOs can’t do both, and what separates the ones that can.
  • Technology transfer at pace: Proven strategies to achieve first GMP batch in as little as nine months.
  • Future-ready facilities: How modular design, cross-trained teams, and supply chain redundancy enable true agility.
  • Compliance from day one: Why early regulatory focus minimizes risk and accelerates approval.

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