The Open Downstream
A qualified GMP product for every step - standard, scalable, customizable. One roof, from bench to patient.
Where the cost and the risk concentrate
Downstream processing carries well over half of a biologic's production cost, and it is where a single mistake is most expensive to unwind. The buffers, stock solutions and water that run through it deserve a qualified partner, not a commodity buy - one that covers every step, scales with the programme and stays consistent from bench to patient.
A qualified product for every downstream step
Seven steps, from harvest to release - the universal stock solutions recur across them, so the same qualified article serves many steps.
- 1Harvest & clarificationDPBS 1x / 10x, WFI water
- 2Capture - Protein ANaCl 5 M, Tris 1 M, Citrate, Glycine
- 3Viral inactivation (low-pH)Citrate 100 mM pH 3.0, Tris 1 M
- 4Polishing - IEX / HIC / SECAcetate, Phosphate, Amm. sulfate, Histidine, NaOH
- 5Ultrafiltration / diafiltrationHistidine, Sucrose, Trehalose, PS20 / PS80
- 6FormulationHistidine, Sucrose / Trehalose, PS20 / PS80, NaCl 5 M
- 7QC & releaseCertificate of Analysis, DMF support, stability
The standard portfolio, by function
One stocked size per product (500 ml or 100 ml) with its article number; 1000 ml bottles and 1-1000 L single-use bags on request; a WFI Beyond version of every buffer on request. 32 products across six functional families, each linked to its own product page (click any row). The same products are grouped under Products › Downstream / DSP.
Foundation - water & isotonic bases3 products
Salts & ionic-strength stocks4 products
- NaCl 5 M, Stock SolutionCT-77055Ionic strength / gradient elution - all chromatography; tonicity
- Ammonium Sulfate 1 MCT-67500HIC binding salt; salt precipitation
- Ammonium Sulfate 3 MCT-68500Higher-strength HIC loading; precipitation
- Magnesium Chloride 1 M solutionCT-75100Nuclease cofactor (DSP); IVT cofactor (mRNA)
pH / buffering stocks8 products
- Tris Buffer 1 M, pH 8.4CT-05500Equilibration, neutralisation, AEX, TE/lysis base
- Phosphate Buffer 100 mMCT-18810AEX, polishing, formulation
- Sodium Acetate 100 mM, pH 4.5CT-76451CEX, UF/DF, formulation
- Citrate Buffer 100 mM, pH 3.0CT-62500Protein A elution + low-pH viral inactivation
- Glycine 100 mM Buffer, pH 3.0CT-69500Alternative Protein A elution / low-pH hold
- Histidine 100 mMCT-69510SEC, UF/DF, primary mAb formulation buffer
- HEPES Buffer 1 MCT-01100pH stabilisation for handling / sampling
- Sodium citrate, neutral (~pH 6.5)CT-62310mRNA storage; general neutral-citrate buffering
Chelation, lysis & nucleic-acid clearance6 products
- EDTA 0.5 M, pH 8.0CT-10500Chelation in TE, equilibration, elution, endotoxin removal
- Triton X-100 10% SolutionCT-01001Lysis, enveloped-virus inactivation, dsRNA control
- Endonuclease SolutionCT-77351Host-cell / residual DNA-RNA digestion; nucleic-acid clearance
- Potassium acetate 3 M, pH 5.5CT-76500Alkaline-lysis neutralisation (pDNA)
- SDS 10%CT-06500Alkaline cell lysis (pDNA)
- Triton CG-110 (xenofree)CT-01101Xenofree detergent for animal-free platforms
CIP, sanitisation & storage2 products
Stabilisers & formulation excipients9 products
- Sucrose 30% Stock SolutionCT-00131Cryo-/lyo-protectant, stability excipient
- Trehalose 30% Stock SolutionCT-00231Alternative cryoprotectant (lyo / SC)
- Polysorbate 20 (PS20) 1%CT-00211Anti-aggregation surfactant (IV mAb)
- Polysorbate 80 (PS80) 1%CT-00311Surfactant (SC / lyo)
- Glucose 20% Stock SolutionCT-00331Process additive / feed
- L-Arginine 1 M, pH 7.0CT-69520Viscosity / aggregation control in high-conc mAb
- Mannitol 10% (w/v)CT-00401Bulking agent for lyophilised products
- Recombinant human serum albumin (rHSA)CT-27500Animal-free stabiliser for vectors, cell products
- Glycerol 20% (v/v)CT-00901Cryoprotectant for viral vectors / cell banks
One partner, four options, four applications
Built for four modalities
Case studies
Real, anonymised proof from PAN's GMP downstream and supply partnerships.
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.
Read the case study~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.
Read the case studyFrom 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.
Read the case studySecuring supply after a supplier discontinuation
An incumbent supplier exited; PAN took the RUO product end-to-end under PAN Complete.
Read the case studyA private-label GMP line for Europe
A global brand launched a private-label GMP (EU Annex 1) line - without building a plant.
Read the case studyWhitepapers
The Open Downstream
Why downstream is where cost, quality and regulatory risk concentrate - and how owning the options takes the risk off the table.
Read the paperBeyond Compendial - Buffers & Reagents
The impurity dossier - elemental impurities, residual solvents, nitrosamines, leachables - mapped to mAb, mRNA, cell & gene and vaccine.
Read the paperFrom Bench to GMP
The make-versus-buy decision for process buffers - the five hidden costs of staying in-house at GMP scale, and how to organise the switch.
Read the paperWFI Beyond
Water for Injection engineered beyond the compendial monograph - the opt-in quality ceiling under every buffer.
Read the paperFrequently asked questions
What is the Open Downstream range?
It is PAN-Biotech's complete GMP downstream (DSP) system: a qualified stock solution, buffer or reagent for every step of a biologic purification - capture, viral inactivation, chromatographic polishing, ultrafiltration / diafiltration and final formulation - manufactured by PAN-Celltech. One partner, from bench to patient.
Do you have a GMP product for every downstream step?
Yes. A small set of universal stock solutions - NaCl 5 M, Tris 1 M, citrate, acetate, phosphate, histidine and the water beneath them - recurs across step after step. Standard items are in stock; custom GMP formulations cover the process-specific tail.
Where can I see each product?
Every catalogue product below links to its own product page with composition, pack size and article number. The same products are also grouped under Products > Downstream / DSP.
Which buffer is used for Protein A elution?
Citrate Buffer 100 mM, pH 3.0 (CT-62500) is the standard low-pH elution buffer, and it doubles as the low-pH viral-inactivation hold. Glycine 100 mM, pH 3.0 (CT-69500) is the alternative.
What pack sizes are available?
Each standard product is stocked in one defined pack size with its own article number - 500 ml for high-volume buffers, salts, CIP reagents and water; 100 ml for concentrated excipients and additives. 1000 ml bottles and single-use bags from 1 L to 1000 L are available on request.
Can I get the buffers beyond compendial?
Yes. Every downstream buffer is also available in a beyond-compendial version produced with WFI Beyond - Water for Injection engineered beyond the Ph. Eur. / USP monograph - on request. WFI Beyond is opt-in, ordered exactly where a molecule needs it.
Can you make a custom formulation?
Yes. At any step a standard product can become a fully customized GMP formulation manufactured by PAN-Celltech to your own recipe - without switching supplier or restarting qualification.
Are the products GMP grade?
The core range is catalogue GMP, manufactured by PAN-Celltech to GMP in an EU Annex 1 facility within an ISO 9001 quality system, with a Certificate of Analysis on every lot. DPBS (CT-36500) and WFI Beyond are additionally backed by filed FDA Type IV Drug Master Files.
How fast do you ship?
Standard in-stock catalogue items are dispatched worldwide within 24 hours of order. Larger formats and custom or beyond-compendial versions are produced to order.