The Open mRNA Process
A qualified toolkit for the whole mRNA process - buffers, solvents and excipients from template preparation to the formulated LNP drug product, standardised and de-risked. From research to GMP, from one manufacturer.
A cell-free process, built on shared stocks
mRNA is a cell-free process, made by in-vitro transcription. From nuclease-free water through transcription and reaction buffers, RNA-purification and diafiltration stocks, LNP solvents and excipient-grade formulation, PAN-Biotech delivers the coherent process chemistry that carries an mRNA product from template to the final formulated drug product. A small set of qualified PAN buffers, solvents and stabilisers recurs across the whole workflow - one partner, one qualified supply base, from research to GMP.
A long chain of buffers and reagents, from one supply base
An mRNA programme runs on a long chain of buffers, salts, solvents and excipients - from the IVT reaction through purification, LNP encapsulation and final formulation. Sourcing them from many suppliers slows qualification and scale-up. PAN-Biotech consolidates the water, buffer, solvent and excipient chemistry into one qualified GMP supply base, so a programme can stay with one supplier from research to GMP.
One cell-free chain, from template to drug product
Upstream (USP) - template preparation, in-vitro transcription and template removal. The mRNA itself is made cell-free; the optional cell-based step supports transfection studies only.
M0 · Cell-based Studies / Transfection (optional)3 products
- Panserin 293S, Serum-free medium for HEK-Cells in suspension culture, w: L-GlutamineP04-710609GMP grade on requestHEK293 suspension medium for transfection-based mRNA studies.
- Panserin 293A, Serum-free medium for HEK-Cells in adherent culture, w: L-GlutamineP04-710608GMP grade on requestHEK293 adherent medium.
- Panserin 401 (HEK293 / allround)P04-710401GMP grade on requestSerum-free allround medium.
M1 · Template DNA Preparation8 products
- SDS 10 %CT-06500Alkaline-lysis detergent for plasmid (pDNA) template production.
- 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.
- RNase/DNase Neutralizer, Nuclease Decontamination solutionP10-61500Surface / equipment decontamination.
- Tris Buffer 1 M, pH 8.4CT-05500TE / resuspension buffer base.
- EDTA 0.5 M, pH 8.0CT-10500TE buffer / chelation.
- NaCl 5 M, stock solutionCT-77055Precipitation / wash buffer.
- Ethanol 20 %CT-89500DNA precipitation / wash.
- Potassium acetate 3 M, pH 5.5CT-76500Precipitation buffer.
M2 · In Vitro Transcription (IVT)4 products
- Tris Buffer 1 M, pH 8.4CT-05500IVT transcription buffer base.
- Magnesium Chloride 1 MCT-75100IVT cofactor.
- 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.
- IVT Reaction Buffer 10xCT-14100Ready-to-use transcription buffer - PAN product on request. PAN already supplies the components.
M3 · DNase Digestion3 products
Downstream (DSP) - purification, LNP encapsulation, buffer exchange and excipient-grade formulation. The buffer, solvent and stabiliser stocks are largely shared across the steps.
M4 · RNA Purification10 products
- NaCl 5 M, stock solutionCT-77055High-salt purification buffer.
- EDTA 0.5 M, pH 8.0CT-10500Chelation / stabilisation.
- Glycine 100 mM, pH 3.0CT-69500Low-pH elution buffer.
- Tris Buffer 1 M, pH 8.4CT-05500Chromatography buffer base.
- Phosphate Buffer 100 mMCT-18810Buffer base.
- DPBS w/o Ca & Mg, GMP gradeCT-36500Wash / equilibration buffer. RUO: P04-36500.
- HEPES Buffer 1 M, GMP gradeCT-01100Buffer base.
- NaOH 1 M, stock solutionCT-55105pH adjustment.
- 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.
M5 · LNP Manufacturing & Encapsulation8 products
- Ethanol 20 %CT-89500Lipid stock solvent (organic phase).
- Sodium acetate 100 mM, pH 4.5CT-76451Acidic mixing buffer.
- Citrate Buffer 100 mM, pH 3.0CT-62500Low-pH mixing buffer.
- Sucrose 30 % stock solutionCT-00131Cryo-/stabiliser.
- Polysorbate 80 (PS80) 1 %CT-00311LNP surfactant / stabiliser.
- Histidine 100 mMCT-69510LNP mixing / formulation buffer.
- DPBS w/o Ca & Mg, GMP gradeCT-36500Aqueous mixing phase. RUO: P04-36500.
- 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.
M6 · Solvent Removal / TFF7 products
- Tris Buffer 1 M, pH 8.4CT-05500Diafiltration exchange buffer.
- NaCl 5 M, stock solutionCT-77055Ionic strength adjustment.
- Phosphate Buffer 100 mMCT-18810Exchange buffer.
- Sodium citrate, neutral (~pH 6.5)CT-62310Neutral storage buffer.
- DPBS w/o Ca & Mg, GMP gradeCT-36500Buffer exchange base. RUO: P04-36500.
- HEPES Buffer 1 M, GMP gradeCT-01100Exchange 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.
M7 · Formulation (excipients grade)14 products
- Histidine 100 mMCT-69510LNP formulation buffer (mRNA-LNP standard).
- Tris Buffer 1 M, pH 8.4CT-05500Tris (tromethamine) formulation buffer.
- Phosphate Buffer 100 mMCT-18810Formulation buffer.
- Sodium chloride solution 0,9 %, GMP gradeCT-39500Isotonic saline. RUO: P05-39500.
- L-Arginine 1 M, pH 7.0CT-69520Tonicity / stabiliser.
- Glycerol 20 % (v/v)CT-00901Cryoprotectant.
- Polysorbate 20 (PS20) 1 %CT-00211Surfactant / aggregation control.
- Polysorbate 80 (PS80) 1 %CT-00311Surfactant / aggregation control.
- Recombinant human serum albumin (rHSA)CT-27500Animal-free stabiliser.
- Mannitol 10 % (w/v)CT-00401Bulking agent / lyo.
- Sucrose 30 % stock solutionCT-00131Cryoprotectant.
- Trehalose 30 % stock solutionCT-00231Lyoprotectant.
- NaOH 1 M, stock solutionCT-55105pH adjustment.
- 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.
M8 · Fill & Storage3 products
M9 · Quality Control, Analytics & Stability StudiesQC & release
Quality control & stability - CoA on every lot; and, on request, ICH-compliant validated stability studies.
Regulatory support - With multiple products backed by an active FDA Type IV Drug Master File, we can accompany you through the DMF (Drug Master File) application process. The DMF is listed with the FDA and can be referenced in your own submission via a Letter of Authorization.
Buffer, solvent and excipient chemistry - from research to GMP
PAN-Biotech covers the water, transcription and reaction buffers, LNP solvents and excipient-grade formulation chemistry of the mRNA process - so a programme can stay with one qualified supplier from first research runs to GMP manufacturing.
WFI Beyond and RNase/DNase Neutralizer keep the whole workflow nuclease-free; DNase I removes the DNA template after transcription.
Tris and Magnesium Chloride form the IVT reaction buffer base - with a ready-to-use IVT Reaction Buffer 10x on request.
Ethanol as the lipid-stock solvent, plus acetate, citrate and histidine mixing buffers for lipid-nanoparticle formation and encapsulation.
Histidine and Tris formulation buffers, polysorbates, sucrose, trehalose, mannitol, rHSA and WFI Beyond - the excipient chemistry of the final drug product.
A handful of stocks, reused across the process
Rather than a separate finished buffer for every step, the mRNA 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, solvents and formulation excipients carry a CT article number and are available directly, several also with a research-grade (RUO, P-) equivalent. A few are GMP on request, and a ready-to-use IVT reaction buffer is a new portfolio addition. 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
Anonymised proof from PAN's GMP downstream and supply partnerships. Each story lives once in the Knowledge Hub.
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 studyFrom in-house buffer prep to a qualified GMP supply partner
A cell-and-gene-therapy developer moves from making its own buffers to one audited GMP source (DPBS CT-36500).
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 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 studyWhitepapers & technical 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 cell & gene, mRNA, mAb 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 paperA 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.