The Open Liposome Process
A qualified toolkit for the whole liposome and lipid-nanoparticle process - buffers, stock solutions and excipients from buffer preparation to the formulated drug product, standardised and de-risked. From research to GMP, from one manufacturer.
A lipid-based process, built on shared stocks
A liposome or lipid-nanoparticle (LNP) product is built by dissolving lipids in an organic phase and combining them with an aqueous phase to form vesicles, which are then size-reduced, purified, formulated and filled. From nuclease-free water through hydration and mixing buffers, diafiltration and purification stocks, to excipient-grade formulation, PAN-Biotech delivers the coherent process chemistry that carries a liposome product from lipid stock to the final formulated drug product. A small set of qualified PAN buffers, stock solutions and stabilisers recurs across the whole workflow - one partner, one qualified supply base, from research to GMP.
A chain of buffers, stock solutions and excipients, from one supply base
A liposome programme runs on a long chain of buffers, salts, solvents and excipients - from lipid stock and buffer preparation through vesicle formation, size reduction, purification and final formulation. Sourcing them from many suppliers slows qualification and scale-up. PAN-Biotech consolidates the water, buffer, stock-solution and excipient chemistry into one qualified GMP supply base, so a programme can stay with one supplier from research to GMP.
One lipid-based chain, from lipid stock to drug product
Upstream (USP) - lipid stock & buffer preparation, liposome formation and size reduction (L1-L3).
Lipids are dissolved in an organic phase, typically absolute ethanol.
L1 · Aqueous / Buffer Preparation14 products
- Ammonium sulfate 1 MCT-67500Hydration / remote-loading gradient buffer (weak-base drug loading).
- Ammonium sulfate 3 MCT-68500Concentrated ammonium sulfate stock for hydration gradients.
- HEPES Buffer 1 M, GMP gradeCT-01100Hydration buffer; physiological pH.
- Phosphate Buffer 100 mMCT-18810Hydration / phosphate buffer base.
- Sodium acetate 100 mM, pH 4.5CT-76451Acidic acetate buffer for nucleic-acid loading.
- Tris Buffer 1 M, pH 8.4CT-05500Tris hydration buffer base.
- Citrate Buffer 100 mM, pH 3.0CT-62500Acidic citrate buffer.
- WFI Beyond, Water for Injection, acc. to EP monograph 0169 and beyond compendialCT-981500Metal-controlled, ultra-low endotoxin and nuclease-free water base - DMF-backed, beyond compendial.
- Acetic acid 1 MCT-88500Acetate-buffer preparation and pH adjustment for nucleic-acid loading / mixing; tested RNase- and DNase-free.
- Sodium citrate, neutral (~pH 6.5)CT-62310Neutral citrate buffer for formulation / hydration.
- Potassium acetate 3 M, pH 5.5CT-76500Concentrated acetate buffer (K+ form) for hydration / loading.
- Glycine 100 mM, pH 3.0CT-69500Low-pH glycine buffer option.
- NaOH 1 M, stock solutionCT-55105Base for pH adjustment (acid side: Acetic acid 1 M, above).
- RNase/DNase Neutralizer, Nuclease Decontamination solutionP10-61500Surface / equipment decontamination for nucleic-acid payloads.
L2 · Liposome Formation (Hydration / Microfluidic Mixing)5 products
- Sodium acetate 100 mM, pH 4.5CT-76451Aqueous phase for microfluidic mixing (nucleic-acid lipid nanoparticles).
- Citrate Buffer 100 mM, pH 3.0CT-62500Low-pH aqueous phase for mixing.
- WFI Beyond, Water for Injection, acc. to EP monograph 0169 and beyond compendialCT-981500Metal-controlled, ultra-low endotoxin and nuclease-free water base - DMF-backed, beyond compendial.
- PANclear APG 10% SolutionCT-01101GMP - productionAlkyl-polyglucoside detergent for detergent-removal (dialysis) vesicle formation; suitability to be confirmed in your process.
- PANclear Octoxynol 10% SolutionCT-01001RUO - research onlyOctylphenol-ethoxylate detergent for research-scale, detergent-based vesicle formation and solubilisation.
L3 · Size Reduction (Extrusion / Homogenisation)4 products
- Phosphate Buffer 100 mMCT-18810Running buffer during extrusion / homogenisation.
- HEPES Buffer 1 M, GMP gradeCT-01100Running buffer.
- Sodium chloride solution 0,9 %, GMP gradeCT-39500Isotonic running / rinse solution.
- WFI Beyond, Water for Injection, acc. to EP monograph 0169 and beyond compendialCT-981500Metal-controlled, ultra-low endotoxin and nuclease-free water base - DMF-backed, beyond compendial.
Downstream (DSP) - solvent removal & buffer exchange, purification, formulation and fill (L4-L7); QC & stability service (L8).
L4 · Solvent Removal & Buffer Exchange (TFF / Diafiltration / Dialysis)10 products
- Phosphate Buffer 100 mMCT-18810Diafiltration exchange buffer.
- Tris Buffer 1 M, pH 8.4CT-05500Diafiltration exchange buffer base.
- Sodium chloride solution 0,9 %, GMP gradeCT-39500Saline for dialysis / diafiltration.
- NaCl 5 M, stock solutionCT-77055Ionic-strength adjustment.
- Pluronic® F-68 10 %, GMP gradeCT-02110Membrane / shear protection in TFF.
- WFI Beyond, Water for Injection, acc. to EP monograph 0169 and beyond compendialCT-981500Metal-controlled, ultra-low endotoxin and nuclease-free water base - DMF-backed, beyond compendial.
- DPBS w/o Ca & Mg, GMP gradeCT-36500Isotonic exchange / dilution buffer (Ca/Mg-free).
- DPBS (10x) w/o Ca & Mg, GMP gradeCT-5350010x concentrate for large-volume diafiltration exchange buffer (Ca/Mg-free).
- NaOH 1 M, stock solutionCT-55105Cleaning-in-place and sanitisation of TFF systems.
- Ethanol 20 %CT-89500Storage and sanitisation of TFF membranes.
L5 · Purification8 products
- NaCl 5 M, stock solutionCT-77055High-salt wash for purification.
- EDTA 0.5 M, pH 8.0CT-10500Chelator; removes divalent cations.
- PANclear APG 10% SolutionCT-01101GMP - productionAnimal-free detergent for vesicle lysis in in-process analytics; suitability to be confirmed in your process.
- PANclear Octoxynol 10% SolutionCT-01001RUO - research onlyDetergent for vesicle lysis in in-process analytics, e.g. encapsulation efficiency.
- Phosphate Buffer 100 mMCT-18810Purification buffer base.
- WFI Beyond, Water for Injection, acc. to EP monograph 0169 and beyond compendialCT-981500Metal-controlled, ultra-low endotoxin and nuclease-free water base - DMF-backed, beyond compendial.
- NaOH 1 M, stock solutionCT-55105Cleaning-in-place and sanitisation of chromatography columns.
- Ethanol 20 %CT-89500Column storage and sanitisation.
L6 · Formulation & Stabilisation15 products
- Histidine 100 mMCT-69510Formulation buffer.
- Phosphate Buffer 100 mMCT-18810Phosphate formulation buffer base.
- Sodium chloride solution 0,9 %, GMP gradeCT-39500Tonicity adjustment.
- Sucrose 30 % stock solutionCT-00131Cryoprotectant.
- Trehalose 30 % stock solutionCT-00231Cryoprotectant.
- Mannitol 10 % (w/v)CT-00401Bulking agent / stabiliser.
- Glycerol 20 % (v/v)CT-00901Stabiliser / cryoprotectant.
- Polysorbate 20 (PS20) 1 %CT-00211Optional surfactant at low concentration; bilayer compatibility to be confirmed in your formulation.
- Polysorbate 80 (PS80) 1 %CT-00311Optional surfactant at low concentration; bilayer compatibility to be confirmed in your formulation.
- Recombinant human serum albumin (rHSA)CT-27500Protein stabiliser (animal-free).
- WFI Beyond, Water for Injection, acc. to EP monograph 0169 and beyond compendialCT-981500Metal-controlled, ultra-low endotoxin and nuclease-free water base - DMF-backed, beyond compendial.
- Glucose 20 % stock solutionCT-00331Dextrose base (D5W) - tonicity / formulation medium.
- L-Arginine 1 M, pH 7.0CT-69520Aggregation suppressant / colloidal stabiliser.
- DPBS w/o Ca & Mg, GMP gradeCT-36500Isotonic storage / resuspension buffer (Ca/Mg-free).
- Tris Buffer 1 M, pH 8.4CT-05500Tris formulation buffer base, e.g. Tris / sucrose formulations.
L7 · Fill & Storage5 products
- Sucrose 30 % stock solutionCT-00131Cryoprotectant for frozen storage.
- Trehalose 30 % stock solutionCT-00231Cryoprotectant for lyophilisation.
- Sodium chloride solution 0,9 %, GMP gradeCT-39500Isotonic diluent.
- WFI Beyond, Water for Injection, acc. to EP monograph 0169 and beyond compendialCT-981500Metal-controlled, ultra-low endotoxin and nuclease-free water base - DMF-backed, beyond compendial.
- Glucose 20 % stock solutionCT-00331Dextrose diluent (D5W) for final dilution / fill.
L8 · Quality Control & Analytics + Stability StudiesService
- QC & stability (PAN Quality Test & Research Center)serviceEndotoxin, sterility, pH, osmolality, particle size / PDI, zeta potential, encapsulation efficiency; ICH Q1A stability.
Buffer, stock-solution and excipient chemistry - from research to GMP
PAN-Biotech covers the water, hydration and mixing buffers, process stocks and excipient-grade formulation chemistry of the liposome process - so a programme can stay with one qualified supplier from first research runs to GMP manufacturing.
WFI Beyond - metal-controlled, ultra-low endotoxin and nuclease-free - is the aqueous base of every buffer, hydration, exchange and formulation step.
Phosphate, HEPES, Tris and neutral citrate for hydration at physiological pH, plus ammonium sulfate stocks for remote-loading gradients.
Acidic acetate and citrate buffers for the aqueous phase of microfluidic mixing, with Acetic acid 1 M and NaOH 1 M for pH adjustment.
Histidine, phosphate and Tris buffers, DPBS and 0.9 % saline, polysorbates, sucrose, trehalose, mannitol, glycerol, L-arginine and rHSA - the excipient chemistry of the final product.
A handful of stocks, reused across the process
Rather than a separate finished buffer for every step, the liposome process is built on a few concentrated stock solutions that recur across the workflow - one qualified stock covers several steps, so there are fewer SKUs to qualify and full freedom to prepare working buffers to your own recipe. How often each recurs:
The GMP and regulatory foundation
Most products named here are manufactured by PAN-Celltech and available at GMP grade; the buffers, salts, stock solutions and formulation excipients carry a CT article number and are available directly, several also with a research-grade (RUO, P-) equivalent. Two are research grade only: PANclear Octoxynol and the RNase/DNase Neutralizer. Two of the most-used utilities go further: DPBS (CT-36500) and WFI Beyond are backed by filed FDA Drug Master Files that customers can reference in their own submissions. And we go one step further: on a customer's request, we will file the PAN products they use with the FDA as well. A DMF-listed product makes their documentation and approval process faster and easier - the same regulatory shortcut we already provide for DPBS and WFI Beyond, extended to the products that matter most to them. Manufactured to GMP in an EU Annex 1 facility within an ISO 9001 quality system - audit-proven and GMP-compliant, with GMP compliance confirmed in customer audits. One qualified stock covers several steps; a fully customized GMP formulation is available at any step, to your recipe, without switching supplier.
Beyond compendial, on request
Water is the base of every buffer and stock, so it sets the floor for the whole process. Alongside standard WFI quality water, PAN offers WFI Beyond - Water for Injection engineered beyond the Ph. Eur. / USP monograph and backed by its own filed Drug Master File. Every downstream buffer on this page is available in a beyond-compendial version produced with WFI Beyond, on request, for processes with the most demanding endotoxin and purity requirements - one qualified foundation, reused everywhere.
Case studies
Real, anonymised proof from PAN's GMP 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 studyWFI Beyond in 1 mL vials for clinical CAR-T manufacturing
A CAR-T developer needed nuclease-free, ultra-low-endotoxin water for plasmid dilution - custom-filled WFI Beyond in 1 mL vials, enquiry to release in about eight weeks.
Read the case studyScaling up WFI for a GMP clean room
WFI Beyond in single-use bags up to 1000 L stays outside the clean room - only the tubing line enters, aseptically, through a wall connector. No clean-room crane, no open transfer.
Read the case studyTechnical papers
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 paperChoosing a Viral-Inactivation Detergent
Four requirements - performance, compliant supply under REACH, animal origin and per-lot documentation - turned into a checklist, with PANclear APG for GMP production and PANclear Octoxynol for research.
Read the paperSwitching off the REACH Trap
Six steps and a checklist for moving viral inactivation off octylphenol ethoxylates subject to REACH authorisation - with a 100 ml to 1000 L scale path on one grade.
Read the paperWFI Beyond - Elemental Stability
All 24 ICH Q3D elemental impurities still below limit at the 18-month stability point - in PET and PETG, 500 mL and 1000 mL.
Read the paperRead In-Depth Edition A06 · Liposomes Read In-Depth Edition D02 · Water
A qualified partner, not a commodity buy
PAN-Celltech manufactures to GMP in an EU Annex 1 facility (a capability, not a certification), with a Certificate of Analysis on every GMP lot.