24/7 BioPharma: Changing expectations in development and manufacturing

Where are pharma and biotech companies’ expectations of development and manufacturing partners changing most quickly?

The biggest shift is that capacity alone no longer wins work. Quality and compliant facilities are now treated as table stakes, and customers want to feel assured of on-time delivery, every time. Industry surveys show that reliability, execution, and cost competitiveness are now key differentiators, fostering confidence in choosing partners.

Alongside that, sponsors want fewer handoffs. For complex modalities like ADCs and AOCs, they increasingly ask for antibody, linker-payload, conjugation, analytics and ideally fill-finish under one quality system, because every interface between vendors are points of erosion of knowledge and extended timelines. Geography has also become a live selection criterion, with BIOSECURE and tariff pressure pushing programs toward US and European conjugation capacity. And expectations of scientific honesty have risen sharply, customers want a partner who will tell them early that a design won’t scale, not one that quietly runs the campaign anyway.

Where do projects still lose unnecessary time or momentum, and what could partners be doing differently to prevent that?

Honestly, the majority of “lost time” isn’t lost in the GMP suite, it’s lost at the handoffs. Tech transfer is the classic offender. Industry analysis suggests that the majority of biologics transfers hit significant timeline deviations, with the usual culprits being incomplete process characterization, analytical method gaps between development and QC, and reactive comparability planning. Analytical methods, especially potency assays, sit on the critical path far more often than people expect.

The other big one is deferred manufacturability thinking. If you pick a lead on potency data alone and only later discover the conjugation chemistry aggregates, or that your oligo loading ratio wrecks clearance, you’re re-engineering a molecule that’s already in tox.

So, what should partners do differently to avoid this issue? They need to bring manufacturing and analytical development into lead selection, not after it, and run developability and platform-fit assessments early. There needs to be a transfer of tribal knowledge: the deviations, the operator observations, the reasons behind choices, not just the batch record. Agree on a risk-ranked gap register up front and build engineering runs in rather than hoping to avoid them.

What shifts in customer priorities do you expect to dominate conversations at CPHI this year, and what do they tell us about where the market is heading?

I’d expect four themes to dominate. First, Resilience & Geography: Onshoring, BIOSECURE fallout and tariff exposure have made supply-chain origin a board-level question, not just a procurement footnote.

Second, Cost Discipline Meeting Complexity: Sponsors are more cost-sensitive while the molecules get harder, so conversations turn quickly to COGS, yield and how early design choices lock in expense.

Third, AI: which the organizers flag as touching manufacturing optimization, quality, compliance and logistics. I expect plenty of enthusiasm alongside healthy skepticism about what’s actually validated. Fourth, Sustainability: this year has a dedicated summit aimed at progressing from rhetoric to practical action.

Underneath all of it sits the end-to-end versus expert-led debate, which I think points us to the market consolidating around CDMO partners who combine specialist depth in hard modalities with enough integration to remove handoffs, with proven resilience. Buyers are optimizing for certainty now, not necessarily the cheapest quote.

What will distinguish the most successful development and manufacturing partners over the next few years?

Over the next few years, three themes will distinguish the most successful CDMO partners. The first will be proving delivery rather than describing it. There seems to be a discrepancy in survey data where on-time delivery is the top selection criterion yet sponsors rank CDMOs’ actual performance on it near the bottom. Credible schedule-adherence data puts manufacturing partners ahead of those that only talk about it.

Second will be genuine technical depth in the difficult modalities. ADCs, AOCs, bispecifics & radioconjugates punish generalists because controlling DAR, managing oligo loading ratios and pre-annealing behavior, and building orthogonal analytics for these molecules is specialist work. Partners with proprietary tools and real problem-solving scar tissue will keep beating those who are just offering capacity.

The third is integration with judgment. End-to-end support matters, but only when the organization uses the knowledge it holds by feeding manufacturability into design, flagging risks early, and behaving like part of the customer’s team rather than a vendor. Add financial stability and transparent governance, and that’s the profile. The winners will be the ones sponsors trust to protect their timeline.

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