The Open Vaccine Production Process
A qualified toolkit for the whole vaccine-production process - standardised and de-risked, from cell substrate to formulated vaccine. Research-grade upstream, GMP downstream, from one manufacturer.
One shared upstream, a modality-specific downstream
Every vaccine starts the same way: expand a substrate cell line, then infect or transfect it. PAN-Biotech covers that shared upstream almost end to end - including the cell-line-specific viral culture media that define the platform. Downstream then branches by modality, but the buffer, nuclease and stabiliser chemistry is largely shared - so a small set of qualified stocks recurs across the whole process.
Speed and consistency, without a fragmented supply base
Vaccine programmes juggle emerging-pathogen timelines, yield and lot-to-lot consistency, and a downstream that changes with the modality. Sourcing media, buffers and excipients from many suppliers slows qualification and scale-up. PAN-Biotech consolidates the media and process chemistry - cell-line-specific culture media, buffered salt solutions, nuclease and formulation excipients - into one qualified supply base that moves from research to GMP.
Shared upstream, then a modality-specific downstream
Shared upstream - the same substrate expansion and infection/transfection steps feed every vaccine modality.
V1 · Cell Line Development & Maintenance6 products
- Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP)CT-991500Water base for all buffers and media.
- DPBS w/o Ca & MgP04-36500CT-36500Cell washing and handling.
- Cryopan II, chemically defined and protein-free freezing mediumP07-93100CT-94100Working / master cell bank cryopreservation.
- Cryopan III, DMSO-free Freezing mediumP07-96100CT-96100DMSO-free cryopreservation.
- Penicillin-Streptomycin, 10.000 U/ml Penicillin, 10 mg/ml StreptomycinP06-07100CT-07110Contamination control.
- L-Glutamine 200 mMP04-80100CT-80100Media supplement.
V2 · Cell Expansionby cell line + shared
Cell-line-specific viral culture media9 products
- Panserin ProVero (Vero cells)P04-710613GMP grade on requestVero-cell viral vaccine production (polio, rabies, influenza).Panserin 293A, Serum-free medium for HEK-Cells in adherent culture, w: L-GlutamineP04-710608GMP grade on requestSerum-free HEK293 medium for viral vector production.Panserin 293S, Serum-free medium for HEK-Cells in suspension culture, w: L-GlutamineP04-710609GMP grade on requestSerum-free HEK293 medium for viral vector production.
- Serum-free Medium for MDCKP04-71105GMP grade on requestMDCK-cell influenza vaccine production.
- EMEM Fibroblast (BHK21)P04-08049GMP grade on requestBHK21 / fibroblast viral vaccine substrates.
- Panserin 401 (BHK21)P04-710401GMP grade on requestSerum-free allround medium (BHK21 and others).
- Spodopan (Sf9/Sf21 insect)P04-850500GMP grade on requestProtein-free insect-cell medium (baculovirus, subunit/VLP).
- Schneider´s Drosophila Medium (S2)P04-90500GMP grade on requestDrosophila S2 insect-cell antigen expression.
- M199 w: EBSS, w: L-Glutamine, w: 2.2 g/L NaHCO₃P04-07050CT-07050
- MEM Eagle w: EBSS, w: L-Glutamine, w: 2.2 g/L NaHCO₃P04-08500CT-08500
- CMRL-1066, w/o: L-Glutamine, w/o: Phenol red, w: 2.2 g/L NaHCO₃P04-84600CT-84600
Base media2 products
Cell dissociation2 products
Antibiotics / antifungals2 products
Growth factors & cytokines (RUO)2 products
Media supplements9 products
- ITS solution I (100x)P07-03100CT-03110Insulin-transferrin-selenium, serum-free supplement.
- Insulin human rec., 10 mg/ml SolutionP07-04300GMP grade on requestSerum-free supplement.
- Stable Glutamine 200 mM (100x)P04-82100CT-82100Stable glutamine supplement.
- Glucose 20 % stock solutionCT-00331Energy source / feed.
- Pluronic® F-68 10 %P08-02100CT-02110Shear protection for suspension / bioreactor culture.
- Sodium bicarbonate 7,5 %P04-44100GMP grade on requestMedia pH buffering.
- Sodium pyruvate 100 mMP04-43100CT-43100Energy supplement.
- MEM NEAA, Non Essential Amino Acid Solution (100x) w/o: L-GlutamineP08-32100CT-32100Non-essential amino acids.
- HEPES Buffer 1 MCT-01100pH buffering (CO₂-independent handling).
V3 · Virus Infection / Transfection3 products
- Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP)CT-991500Infection / dilution.
- DPBS w/o Ca & MgP04-36500CT-36500Handling.
- Transfection reagenton requestTransient transfection for virus rescue, viral-vector vaccines and recombinant antigen expression.
By modality - the downstream path depends on the vaccine type.
Downstream - which steps apply depends on the modality above; the buffer, nuclease and stabiliser stocks are shared.
V4 · Viral Harvesting & Clarification3 products
- Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP)CT-991500Harvest / dilution.
- 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-36500Wash.
V5 · Cell Lysis (non-enveloped / lysis-based)4 products
- SDS 10 %CT-06500Detergent lysis of non-enveloped virus particles.
- PANclear Octoxynol 10% SolutionCT-01001RUO - research onlyEnvelope solubilisation / lysis.PANclear APG 10% SolutionCT-01101GMP - productionAnimal-free detergent - solubilisation / lysis.
- SDS 10 %CT-06500Denaturing lysis.
- EDTA 0.5 M, pH 8.0CT-10500Chelation / protease inhibition.
V6 · Nuclease Treatment3 products
- Endonuclease Solutionon requestBroad-range host-cell DNA/RNA clearance.
- Magnesium Chloride 1 MCT-75100Cofactor for endonuclease.
- DNase IP60-37780100Complementary DNA digestion.
V7 · Purification / Chromatography11 products
- Citrate Buffer 100 mM, pH 3.0CT-62500Low-pH elution buffer (affinity / IEX).
- Ammonium sulfate 1 MCT-67500HIC binding salt; hydrophobic-interaction polishing.
- Ammonium sulfate 3 MCT-68500HIC high-salt load / wash.
- Glycine 100 mM, pH 3.0CT-69500Low-pH elution buffer.
- Ethanol 20 %CT-89500Column CIP / storage (20% ethanol).
- NaCl 5 M, stock solutionCT-77055Ionic strength / IEX.
- Tris Buffer 1 M, pH 8.4CT-05500Buffer stock.
- Phosphate Buffer 100 mMCT-18810Buffer stock.
- Sodium acetate 100 mM, pH 4.5CT-76451Low-pH buffer stock.
- NaOH 1 M, stock solutionCT-55105pH adjustment / buffer titration.
- Sucrose 30 % stock solutionCT-00131Density-gradient purification.
V8 · Concentration / Buffer Exchange (UF-DF)5 products
- Sodium citrate, neutral (~pH 6.5)CT-62310Neutral buffering agent; buffer exchange.
- Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP)CT-991500Diafiltration.
- 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.
- Tris Buffer 1 M, pH 8.4CT-05500Buffer exchange.
- NaCl 5 M, stock solutionCT-77055Buffer exchange.
V9 · Vaccine Formulation (excipients grade)12 products
- Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP)CT-991500Final formulation / diluent base.
- Recombinant human serum albumin (rHSA)CT-27500Animal-free stabiliser.
- Sucrose 30 % stock solutionCT-00131Stabiliser / cryoprotectant.
- Trehalose 30 % stock solutionCT-00231Stabiliser / cryoprotectant.
- Mannitol 10 % (w/v)CT-00401Bulking / stabiliser.
- Glycerol 20 % (v/v)CT-00901Stabiliser.
- Polysorbate 20 (PS20) 1 %CT-00211Surfactant / anti-aggregation.
- Polysorbate 80 (PS80) 1 %CT-00311Surfactant / anti-aggregation.
- Tris Buffer 1 M, pH 8.4CT-05500Formulation buffer.
- NaCl 5 M, stock solutionCT-77055Tonicity adjustment (GMP stock).
- Sodium chloride solution 0,9 %, GMP gradeCT-39500Physiological diluent for final formulation. RUO: P05-39500.
- 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.Histidine 100 mMCT-69510Formulation buffer / stabiliser.
V10 · 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.
Viral culture media expertise - from research to GMP
PAN-Biotech pairs proven, cell-line-specific viral culture media with the downstream buffer and excipient chemistry - so a vaccine programme can stay with one supplier from first research runs to GMP manufacturing.
A handful of stocks, reused across the process
Rather than a separate finished buffer for every step, the vaccine 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 or GMP on request; the recombinant cytokines and growth factors are research grade (RUO). Catalogue GMP items carry a CT article number and are available directly; a few are GMP on request; a small number are new portfolio additions. 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.