Knowledge Hub
PAN's downstream and GMP expertise in one place - proof, science and practical guidance for teams building bioprocesses from bench to patient.
The Knowledge Hub brings together our anonymised customer case studies, the In-Depth Industry Editions, technical whitepapers, the WFI Beyond water standard, and our guides, press and podcast. Everything is free to read; editions and whitepapers are ungated HTML pages with an optional PDF download.
Case studies
Real, anonymised proof from PAN's GMP downstream and supply partnerships.
Browse all case studiesCS-01
~50,000 L of GMP supply in under five weeks
Quote in 3 days; ~50,000 L delivered in under five weeks from first production, to GMP.
CS-02
A two-year OEM bridge, delivered under pressure
A regulatory shutdown took a global supplier's US site offline. PAN bridged ~25 products - ~300,000 bottles over ~2 years, no rejections recorded.
CS-03
A private-label GMP line for Europe
A global brand launched a private-label GMP (EU Annex 1) line in Europe - without building a plant.
CS-04
Securing supply after a supplier discontinuation
An incumbent supplier exited; PAN took the RUO product end-to-end under PAN Complete.
CS-05
From in-house buffer prep to a qualified GMP supply partner
A monoclonal-antibody developer moves from making its own buffers to one audited GMP source.
CS-06
WFI Beyond in 1 mL vials for plasmid dilution
Nuclease-free, ultra-low-endotoxin water custom-filled in 1 mL vials for plasmid dilution in clinical CAR-T manufacturing.
CS-07
Scaling up WFI for a GMP clean room
A cell and gene therapy manufacturer scaled up its WFI demand - WFI Beyond in single-use bags up to 1000 L stays outside the clean room; only the line enters, aseptically, through a wall connector.
Facing a similar challenge?
Tell us about your process, volumes and timeline - our GMP team will come back to you.
Start a projectIn-Depth Industry Editions
Long-form, numbered briefings that set a standard for one topic at a time - two foundation editions (downstream and water) and one per application. Free to read as web pages, each with an optional PDF.
Browse all In-Depth EditionsEdition D01
Standardising the Downstream
One qualified GMP toolkit built from a small set of recurring stock solutions - research grade to GMP, with the process-specific tail covered by custom manufacture.
Edition D02
The WFI Beyond Standard
Why "meets WFI" is only a floor - the beyond-compendial water standard, with all 24 ICH Q3D elemental impurities specified and measured, and the two metals that oxidise an antibody (copper and iron) controlled at the source. FDA Type IV (excipient) DMF filed: MF044505.
Edition A02
Standardising the Antibody Program
The 13-step monoclonal-antibody program - five upstream, seven downstream and a QC & stability step - delivered as ready-to-use process bundles, one labelled box per step.
Edition A03
One Foundation for Cell & Gene Therapy
One serum-free, xeno-free toolkit for the whole cell & gene therapy process - a shared upstream, then the cell-therapy, viral-vector and plasmid-DNA tracks, research to GMP. Built on nuclease-free, ultra-low-endotoxin WFI Beyond.
Edition A04
One Foundation for the Whole mRNA Process
One qualified GMP supply base for the cell-free mRNA process - nuclease-free water and IVT buffers through RNA purification and LNP encapsulation to excipient-grade formulation. Built on WFI Beyond.
Edition A05
One Foundation for the Whole Vaccine Process
One GMP supply base for the whole vaccine process - cell-line-specific viral culture media (Vero, MDCK, BHK21, Sf9, S2), host-cell DNA clearance, purification and excipient-grade formulation.
Whitepapers & technical papers
Commercial and technical, free and ungated.
Go to The Open DownstreamTP-01
The Open Downstream
The commercial case.
TP-02
Beyond Compendial
Buffers & reagents - the impurity dossier.
TP-03
From Bench to GMP
Organizing & scaling your buffer supply.
TP-04
WFI Beyond
The water standard inside every GMP biologic.
TP-05
The Water in the Powder
A ready-to-use medium is ~99% water, so its impurity load is the powder's plus the reconstitution water's - the half almost nobody measures. Why the water belongs in the impurity budget.
TP-06
Choosing a Viral-Inactivation Detergent
Four requirements - performance, compliant supply under REACH, animal origin and per-lot documentation - turned into a checklist, and the two PANclear grades for research and for GMP production.
TP-07
Switching off the REACH Trap
A practical guideline for moving viral inactivation off octylphenol ethoxylates subject to REACH authorisation - six steps, a checklist and a 100 ml to 1000 L scale path.
TP-08
WFI Beyond - Elemental-Impurity Stability
All 24 ICH Q3D elements still below limit at the 18-month stability point, in PET and PETG, 500 mL and 1000 mL - metal control that lasts, not just a release snapshot.
Water, guides & media
The water standard behind every buffer, plus downloads, news and conversations.
What the Knowledge Hub contains
| Resource | What it is | Format | Access |
|---|---|---|---|
| Case studies | Anonymised customer projects (7) | Web page | Free |
| In-Depth Industry Editions | Numbered long-form briefings (6): D01, D02, A02, A03, A04, A05 | Web page + optional PDF | Free, ungated |
| Whitepapers | Commercial and technical papers (8) | Web page + optional PDF | Free, ungated |
| WFI Beyond | Beyond-compendial water standard | Product and science page | Free |
| Downloads | Supplier Qualification Guide, brochures, catalogue | Free | |
| Press · Podcast | Company news and conversations | Web page, audio | Free |
Questions about the Knowledge Hub
What is the PAN-Biotech Knowledge Hub?
Where can I find PAN-Biotech case studies?
What are the In-Depth Industry Editions?
Are the whitepapers free and how do I read them?
Have a process question?
Talk to our GMP team about your downstream, water or supply challenge.