Capacity,-Scale-And-The-Next-Chapter-For-Established-Biologics

A panel discussion at the Danaher Summit 2026 exploring capacity planning and scale-up decisions for established biologics, featuring Silka Maul (Roche MSAT), Ronda Duffy (Biocon Biologics COO), Tar Samad (Lundbeck Research), and John Matulsky (independent consultant). The panel examined real-world tradeoffs leaders face in build-vs-buy decisions, supply reliability under forecast volatility, and the tension between speed, adaptability, and manufacturing quality robustness. Key themes included GLP-1 demand reshaping capacity strategy, the maturation of CDMOs from vendors to strategic partners, and the unprecedented scale of US biomanufacturing investment driven by onshoring and obesity drug demand.

Key Takeaways

Roche committed to becoming a top-three obesity market leader and invested in a new North Carolina GLP-1 plant with digital twin and automated warehouse, deliberately accepting forecast risk rather than paralyzing strategy — while separately implementing formal manufacturability assessments as an independent MSAT check on CMC development.
Biocon Biologics manages extreme biosimilar supply volatility by staging inventory across raw materials, drug substance, and bright stock; EU import QC testing ties up inventory for 8-10 weeks, and insulin shipment from Malaysia requires either 8 weeks by ocean or four aircraft per batch by air.
Lundbeck, which fully outsources biologic manufacturing, is evaluating a hybrid model as its pipeline grows into bispecifics, blood-brain barrier shuttles, and oligonucleotides; rigid CDMO advance commitments are identified as the primary obstacle to rapid clinical pivots.
John Matulsky identifies talent — particularly the mid-level layer of process engineers and QC supervisors — as the single biggest manufacturing constraint amid unprecedented US investment driven by onshoring and GLP-1 demand, with biomanufacturing now competing with data centers for tradespeople.
The CMO-to-CDMO evolution reflects a maturation from transactional vendor relationships to strategic partnerships with shared process development; innovators that refuse to leverage CDMO development expertise ultimately hurt their own programs.
Regulatory scale-up requirements (six months stability for both drug substance and drug product) are a major constraint on biosimilar manufacturers' ability to respond to demand changes; AI-based predictive models were suggested as a potential path to regulatory acceleration.
Silka Maul's key lifecycle management lesson: deferring equipment reinvestment creates situations where aging assets collide with increased portfolio demand, forcing simultaneous old-equipment extension and CDMO search at the worst possible time.