What scales.
What purifies.

09:00

Chair's opening · confirmed

What manufacturing decides.

BILS opens on a single question: not what is possible in biologics manufacturing, but what is required. The standard. The room is here because yield, fidelity and release are not automatic at scale, and the decisions that determine them are made before most people in this building are aware they have been made.

09:30

Opening Keynote · confirmed · 45 min

Building a launch powerhouse for the future of global biologics supply.

The next biologics launch wave is hitting a supply architecture built for a simpler modality mix. Compressing timelines, expanding geography and tightening CMC expectations are converging on organisations still running batch release processes designed before commercial scale was tested. The organisations that survive this are building launch powerhouses, integrated manufacturing and supply operations that hold yield, fidelity and batch integrity under the full weight of global demand. Jens Vogel has built and led at precisely that scale. This is the operational view, not the strategy deck.

• What a biologics launch powerhouse actually requires, the process architecture, batch release discipline and supply chain decisions that hold under commercial demand, not just clinical supply
• Where global biologics supply is structurally exposed, the capacity and platform decisions of 2020 to 2024 and what the launch pipeline of 2026 to 2029 will test against them
• The decisions that cannot be retrofitted once commercial supply is running, the ones that must be made before the queue forms

11:00

Keynote · Joint · BILS + CGTI · confirmed · 40 min

The decision you rarely revisit but always pay for.

Platform selection is the decision that compounds. In biologics manufacturing it determines process fit, scale-up trajectory, regulatory strategy and CDMO relationship architecture for the life of the programme. In cell and gene therapy it is made earlier, under clinical pressure, before commercial consequences are visible, and the error cost is higher. The BILS room has made this decision and operates its consequences. The CGTI room is making it now. Dénes Zalai has seen it made across both modalities from the CDMO side, what the organisations that got it right did, and what the ones that did not had in common. This is the one session where the corridors converge.

• The platform decision most organisations make once, what the ones that got it right did differently, and what the pattern looks like across modalities from the CDMO vantage point
• What the cell and gene therapy room is deciding now that the biologics room already knows, where the lessons transfer and where the biology makes them irrelevant
• The operational, regulatory and commercial consequences that compound from this decision, the ones that are invisible at the time and expensive to unwind later

12:00

Keynote · confirmed · 45 min

From the cell line. Through the platform. To the patient.

The CMC arc from cell line selection through platform process to global supply is rarely managed as a single connected decision chain. Most organisations accumulate it in sequence, and pay for those accumulated choices at commercial scale. WuXi Biologics executes this arc across more simultaneous programmes than any single sponsor. Nuno Fontes brings pattern authority across that portfolio: not the decisions made for one programme, but the structural differences between the ones that hold across the full arc and the ones that do not.

• Where the cell line decision constrains everything downstream, the expression system, process fit, scale trajectory and regulatory strategy that follow from choices made before the bioreactor is specified
• Platform as connective tissue: what the CMC arc looks like when decisions are designed in parallel versus accumulated in sequence, the cost difference at commercial scale
• Cross-programme patterns from global CDMO operations, the failure modes that recur regardless of modality, organisation size or geography

CDMO vantage point. Witness authority across client programmes. The session is framed on what has been observed across the WuXi portfolio, not on WuXi's service capabilities.

14:00

Partner session · Asahi Kasei · confirmed · 30 min

Viral safety as process design.

Viral safety clearance is not a compliance event appended to the manufacturing process. It is an engineering decision made at the beginning of it, or it becomes a risk at the end. This session addresses the process design choices that make viral clearance reliable at commercial scale. Asahi Kasei brings operational authority in membrane-based viral filtration and clearance validation, from the plant floor, not from a regulatory text.

• Where current practice leaves clearance gaps, and how integrated process design eliminates them before the regulator asks
• What a viral safety architecture looks like when it is built in, not appended, the engineering decisions that determine reliability at scale
• The organisations that treat clearance as a terminal documentation step versus the ones that design for it upstream: what the difference looks like in practice

15:00

Panel · confirmed · 50 min

Downstream: what purification actually requires.

Downstream processing accounts for the majority of biologics manufacturing cost and the majority of process failures that do not reach the batch record cleanly. Purification is where the bioreactor's output either becomes a product or does not. Felix Oehme brings the operator's view from inside large-scale biologics development at Bayer, the decisions that determine whether a biologics operation runs at margin and where the current limits are.

• The operational reality of purification at scale: where the real constraints are, and what the industry has not yet solved
• Platform approaches vs process-specific solutions: where standardisation helps and where it costs yield
• What the next generation of biologics manufacturing processes needs to do differently downstream to close the current gap

Moderated by Dr Uwe Gottschalk · additional panellists announced in cadence

09:00

Chair's opening · confirmed

What release carries.

The close of the manufacturing process is not the end of accountability. It is where accountability concentrates. Day Two opens on the release decision: what it means in practice, what it commits the organisation to, and what the room must examine before the patient receives what this process produced.

09:20

Keynote · Day Two Opening · 35 min

The quality decision.

Batch release is where the manufacturing organisation makes its accountability visible. For a biologics company at commercial scale it is also where the decisions made eighteen months earlier in process development either hold or are exposed. Judy Chou has built the quality architecture at AltruBio from the ground up, not inherited it. That means she has had to decide what a quality system is actually for, not just what it is required to contain. That decision is the one this session examines.

• Batch release as the accountability event, what it commits the organisation to and where the architecture that makes it reliable is built, not at the release desk
• What a quality system built for commercial pressure looks like from the ground up, the decisions a biotech makes that an established pharma operator does not
• Where quality architecture and manufacturing discipline diverge, and what happens when the organisation treats them as the same thing

14:00

Plenary · confirmed · 40 min

The CDMO accountability gap.

The industry has outsourced significant manufacturing capacity without building a commensurate accountability architecture. CDMO dependency is now structural, and in some programmes the CDMO carries more process knowledge than the sponsor. When that relationship is under pressure: batch failure, capacity constraint, regulatory hold, the question of who is accountable is not answered by the contract. Jose Martinez has led pharma industrial development at Almirall, the sponsor side of that relationship, at the operational level where the accountability question becomes real.

• Where the contract ends and accountability begins, the gaps that only become visible when the batch fails or the CDMO cannot deliver what the sponsor's commercial timeline requires
• What the sponsor-CDMO relationship looks like at the point of maximum pressure, and how the organisations that have navigated it prepared for that conversation before it became urgent
• What the next generation of sponsor-CDMO alignment must contain: the operational, technical and regulatory dimensions of shared accountability at commercial scale

14:45

Keynote · confirmed · 30 min

session title to be confirmed

Umang Trivedi is confirmed for BILS 2027 Day Two. Session frame and title are outstanding. Once confirmed, this slot will carry the quality and release decision at the global pharma operator level, the counterpart to Judy Chou's opening position.

16:00

Joint close · Chair · 20 min · no slide deck

What both rooms share.

The joint close does not merge the two forums. It names what they share. The biologics manufacturer and the gene therapy operator work in different processes with different biology. They are accountable to the same outcome.

From bioreactor to release. From vector to vein.

16:45

Forum close · confirmed · 15 min

The decision you rarely revisit but always pay for.

Two days. Every session in this room, launch powerhouse architecture, CMC arc, viral clearance, downstream purification, CDMO accountability, batch release, quality governance, traced back to one decision made earlier than most organisations realised was a decision. Platform. The choice that locks process fit, scale trajectory, regulatory strategy and CDMO relationship architecture for the life of a programme. Dénes Zalai has sat on the CDMO side of that decision across many organisations and many modalities. His fifteen minutes will not summarise the forum. They will name the pattern behind it.

Format: 10 min · one opening frame · no deck · Chatham House · witness authority from across client programmes · not a product pitch · closes BILS 2027