Tech transfer portfolio

4 active projects

Projects moving processes between Mesa, Durham and Basel. Gate status reflects the transfer team’s stage-gate records; this view assembles them and flags blockers.

Gate records from DocumentumDemo · read-only

Open comparative workspace

Published fermentation transfer projects

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TT-006 · Gate 2 blocker — bioreactor feed control loop

Bioreactor feed-rate control loop PID cascade constant mapping unmapped at Durham. Durham’s feed loop runs flow-only; Mesa relies on a gravimetric cascade. Gate 2 (Gate 2 Clearance (Engineering & CPP Dossier)) cannot clear until the constants are supplied and reviewed by MSAT.

Open TT-006

Active projects

Blocked gates

TT-006 Gate 2

At risk

TT-005 method transfer

Gate reviews next 14 d

TT-004 G3 · TT-003 G4

Project ledger

Gates: G0 Feasibility → G1 Process & analytics → G2 Engineering & CPP dossier → G3 Engineering run → G4 PPQ readiness

Project	Route	Gates 0–4	Current	Next milestone	Lead	Status
TT-006AB-mAb-014	Mesa 500L single-use→ Durham 2000L stainless	G0 Feasibility: cleared G1 Process & analytics: cleared G2 Engineering & CPP dossier: blocked G3 Engineering run: not started G4 PPQ readiness: not started	Gate 2 · blocked	PID constants from Durham Automation · due 2026-11-06	Alex Rivera	Gate 2 blocker
TT-004AB-mAb-009	Mesa 2000L stainless→ Basel 2000L single-use	G0 Feasibility: cleared G1 Process & analytics: cleared G2 Engineering & CPP dossier: cleared G3 Engineering run: in progress G4 PPQ readiness: not started	Gate 3 · engineering run	Engineering run ER-04 starts 2026-11-02	S. Hoffmann	On plan
TT-005AB-bsAb-021	Durham 200L single-use→ Mesa 500L single-use	G0 Feasibility: cleared G1 Process & analytics: in progress G2 Engineering & CPP dossier: not started G3 Engineering run: not started G4 PPQ readiness: not started	Gate 1 · analytics transfer	Method transfer protocol MTP-021 approval	K. Osei	At risk
TT-003AB-mAb-007	Mesa downstream (UF-DF-02)→ Durham downstream	G0 Feasibility: cleared G1 Process & analytics: cleared G2 Engineering & CPP dossier: cleared G3 Engineering run: cleared G4 PPQ readiness: in progress	Gate 4 · PPQ readiness	PPQ protocol QA review	D. Kim	On plan

No readiness percentages are shown: gate clearance is a QA/MSAT decision recorded in the stage-gate system. Only TT-006 has a comparative workspace in this demo.

Cross-site equipment equivalency · TT-006

Mesa 500L single-use vs Durham 2000L stainless. Values from equipment specifications; blanks are shown as unknown, not estimated.

Full comparison

Aspect	Mesa 500L SUB (donor)	Durham 2000L stainless (recipient)	Comparability	Claim
Aspect ratio (H/D)	1.5 : 1	2.0 : 1	Scaled	Observation
Impeller type	1 × pitched-blade 45°, D/T 0.33	Rushton (lower) + pitched-blade (upper), D/T 0.35	Gap	Observation
Sparger	Drilled-hole 1 mm + open pipe	Ring sparger 2 mm	Gap	Observation
Power per volume (P/V)	42.8 W/m³ (measured)	Unknown · not characterised	Unknown	Unknown
kLa (air, 0.05 vvm)	8.4 h⁻¹	Unknown · ENG-RPT-0447 not issued	Unknown	Unknown
Control system	DeltaV v14 · gravimetric feed cascade	DeltaV v13 · flow-only feed loop	Gap	Observation

Sources: Durham spec is Rev 1 (2023) and may be stale.

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