What changed, and when

Transcenta announced on 28 Dec 2025 a strategic collaboration and non-exclusive license granting EirGenix use of its Highly Intensified Continuous Bioprocessing (HiCB) platform, with upfront, milestones and future royalties disclosed as “substantial” without figures (GlobeNewswire release). Independent carries confirm the terms and non-exclusivity at headline level (Nasdaq brief, Contract Pharma note, MarketScreener item).

60-second thesis frame

This is Transcenta’s first visible monetization of its HiCB process know-how, aiming to turn an internal ICB capability into a platform business, while validating demand for intensified and continuous biomanufacturing among Asian CDMOs (GlobeNewswire release). EirGenix brings PMDA-approved facilities and a growing global CDMO footprint, which could accelerate adoption and client pull-through for HiCB-enabled runs (EirGenix PMDA notice, TaiwanNews coverage, TWSE company profile). HiCB itself is positioned as a perfusion-led upstream with hybrid continuous downstream, co-developed with Merck for automation, and has public productivity claims that, if replicated at EirGenix, could lower CoGs and improve lot-to-lot control (Transcenta HiCB overview, BPI 2020 coverage, PR Newswire 2021). Execution risks concentrate around tech transfer timelines, regulatory comparability for continuous unit ops, and the pace at which EirGenix converts CDMO prospects to HiCB work orders in 2026 (BPI perspective on continuous).

The seven diligence questions

Clinical

• Has HiCB supported any GMP batches used in clinical or commercial filings beyond Transcenta’s internal programs, and what comparability packages were accepted by regulators for continuous or hybrid-continuous steps (if any)? (Context on HiCB claims and prior GMP runs: 200 L perfusion and GMP batch note, 2020; 6 g/L/day perfusion productivity, 2021, Transcenta 200 L GMP note, PR Newswire 2021)
• Which critical quality attributes showed the tightest control when moving from fed-batch to perfusion plus hybrid-continuous purification in HiCB, and what analytical bridging was required? (Transcenta HiCB overview)

Payer or Access

• If HiCB reduces cost of goods, does EirGenix expect clients in tender-heavy markets to translate that into net price advantages or simply margin expansion, and what is the evidence from recent biosimilar tenders? (TWSE company profile)
• Could HiCB throughput enable smaller bioreactor footprints that qualify for local incentives or faster site approvals in Japan and the EU, and would that change pricing strategy for hospital channels? (EirGenix PMDA notice, TaiwanNews coverage)

Ops or Adoption

• What is the expected tech-transfer and validation timeline for the first HiCB-enabled program at EirGenix, including PQ runs and regulatory inspection readiness, given industry-standard complexity for end-to-end continuous? (BPI perspective)
• Are there dependencies on specific upstream media, single-pass TFF, or Merck automation components that create vendor lock-in or supply-chain bottlenecks, and how are second sources qualified? (Transcenta HiCB overview)

Competitive

• How does HiCB’s perfusion productivity and hybrid downstream compare with offerings from global CDMOs and system vendors, and can EirGenix market a tangible cycle-time or CoGs delta to win biosimilar or mAb tenders in 2026? (BPI 2020 coverage)

Team or Cap table

• What portion of Transcenta’s internal team supports external HiCB deployments, how will revenues be recognized across upfront, milestones and royalties, and will the company disclose pipeline vs platform revenue splits in 2026 reporting? (Deal economics framed but undisclosed, GlobeNewswire release, Nasdaq brief)

Red flags

• No public evidence of a first HiCB client batch at EirGenix by mid-2026, suggesting slower-than-expected tech transfer or client uptake. (BPI perspective)
• Material divergence between Transcenta’s stated perfusion productivity and what EirGenix can validate at scale, reducing the CoGs advantage narrative. (BPI 2020 coverage, PR Newswire 2021)
• Limited disclosure on deal economics persists through FY2025 reporting, making it hard to underwrite a repeatable platform revenue stream. (GlobeNewswire release)

Next catalyst

Watch for the first public reference to HiCB-enabled CDMO runs at EirGenix, likely tied to 1H 2026 tech-transfer and qualification milestones, then echoed in monthly or quarterly disclosures and industry events. This is an inference based on typical continuous-processing adoption timelines and EirGenix’s regular disclosure cadence (BPI perspective, TWSE company profile).

FAQ

• What exactly changed by Transcenta’s strategic collaboration and non-exclusive EirGenix licensing news on 28 Dec 2025, and why does it matter for biomanufacturing?
  Transcenta licensed its HiCB platform to EirGenix on a non-exclusive basis with economics comprising upfront, milestones and royalties, aiming to accelerate integrated continuous bioprocessing adoption and lower CoGs (GlobeNewswire release, Nasdaq brief). EirGenix plans to deploy the platform for its own programs and for CDMO clients pursuing intensified and continuous solutions (Contract Pharma note).
• What is the regulatory context after the 28 Dec 2025 announcement by Transcenta, and how prepared is EirGenix for inspections in Japan, the US, and EU?
  EirGenix holds PMDA GMP compliance for its facilities, providing a strong base for Japan-focused supply, with local media noting first-in-Taiwan status in 2020 (EirGenix PMDA notice, TaiwanNews coverage). The firm is positioned on TWSE as a CDMO with PIC/S GMP and international supply capabilities; US or EU specific approvals for HiCB-enabled runs would depend on program-by-program filings (TWSE company profile).
• How does Transcenta’s HiCB technology improve productivity?
  The platform utilizes ultra-high cell density continuous perfusion and hybrid purification to achieve volumetric productivities of over 8 g/L-day. This represents a 10–20 fold increase in output compared to conventional manufacturing methods (Transcenta Technology Page).
• What safety or quality considerations apply post-Transcenta / EirGenix announcement, and do continuous steps change real-world risk?
  Continuous or hybrid-continuous flows require robust process control and analytical bridging to maintain CQAs across longer run times; adoption pace often reflects validation readiness and regulator comfort with specific unit ops and hold-times (BPI perspective). The 28 Dec 2025 deal itself does not change product labels or safety guidance, since it is a manufacturing platform license rather than a therapeutic approval (GlobeNewswire release).
• What is the status of Transcenta’s lead asset, Osemitamab, following this announcement?
  Osemitamab (TST001) remains in active clinical development, recently showing a 16.6-month median PFS in 1L gastric cancer trials presented at ESMO Asia in Dec 2025. The licensing deal provides additional capital to support these ongoing late-stage trials (Transcenta News).

Publisher / Disclosure

Publisher: LucidQuest Ventures Ltd. Produced: 02 Jan 2026, London. Purpose: general and impersonal information. Not investment research or advice, no offer or solicitation, no suitability assessment. UK: directed at investment professionals under Article 19(5) and certain high-net-worth entities under Article 49(2)(a)–(d) of the Financial Promotion Order 2005. Others should not act on this. Sources and accuracy: public sources believed reliable, provided “as is,” may change without notice. No duty to update. Past performance is not reliable. Forward-looking statements carry risks. Methodology: questions-first framework using public sources. No conflicts. Authors do not hold positions unless stated. © 2026 LucidQuest Ventures Ltd.

Entities / Keywords

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