How biotechnology is reshaping pharmaceutical manufacturing: key insights from Klinea’s expert round table

At FARMAFORUM 2025, Klinea brought together industry specialists to examine how biotechnology is reshaping pharmaceutical manufacturing. The discussion revealed key strategic priorities for enabling Spain's biotech sector to scale safely, efficiently and competitively in 2026 and beyond.

Biotechnology is rapidly transforming the pharmaceutical landscape-yet its industrialisation presents challenges that require coordinated technical, regulatory and strategic action. During FARMAFORUM 2025, Klinea hosted the round table "Challenges and opportunities of biotechnology in the pharmaceutical industry," moderated by Jordi Gibert Amat, Head of the Biotechnology Unit. The session gathered experts from across development, engineering and manufacturing to analyse what Spain needs to strengthen its position in a highly competitive global arena.

A first conclusion concerned advanced therapies, an area in which Spain shows scientific strength but faces access limitations driven by cost, scale-up complexity and infrastructure requirements. According to the panel, aligning industrial readiness and economic models earlier in development will be essential to bring these therapies to more patients.

Another key theme was the need to integrate commissioning, qualification and validation (CQV) from the earliest design phases. Experts agreed that embedding CQV into conceptual and basic engineering reduces rework, enhances compliance and shortens time-to-market for biotech processes.

The discussion also underscored the importance of digital continuity-ensuring that data flows consistently from R&D to commercial operations through tools such as PAT, MES/SCADA and electronic batch records. This continuity improves traceability, accelerates deviations management and enables right-first-time manufacturing.

Finally, the panel highlighted the role of ecosystem collaboration. Strengthening bioprocess engineering capabilities, adopting single-use and automation solutions, and building multidisciplinary project teams were identified as critical levers for de-risking biotech industrialisation.

Klinea reaffirms its commitment to translating these insights into practical engineering strategies, supporting companies throughout feasibility, design and operational readiness as Spain advances its biotech manufacturing maturity.

Don't miss the full roundtable on Klinea's YouTube channel: https://lnkd.in/d27gWViw