The Open Cell & Gene Therapy Process
A qualified toolkit for the whole cell & gene therapy process - standardised and de-risked, across three modality tracks from cell collection to the final formulated product. Research-grade upstream, GMP downstream, from one manufacturer.
One shared upstream, three downstream tracks
Cell & gene therapy is not one linear process. All modalities share the same upstream - cell bank/thaw, cell collection/isolation and cell expansion/activation - then diverge into distinct downstream tracks: cell therapy (the cells are the product; no lysis or chromatography), viral-vector / gene therapy (full purification of AAV or lentivirus) and plasmid DNA. PAN-Biotech covers every track with one GMP-grade bundle: catalogue products at each step, universal stock solutions that recur throughout, filed Drug Master Files behind the key utilities, and the option to take any downstream buffer beyond compendial with WFI Beyond.
The fragmented supply challenge
A cell or gene therapy draws on a wide range of ancillary materials - cell-type-specific media, serum replacements, cytokines and growth factors, dissociation reagents, buffers and cryopreservation media. For an ATMP, every one of these is part of the product's safety and regulatory profile. Sourced from a scatter of suppliers - some research-grade only, some animal-derived - that becomes a qualification, documentation and supply-continuity risk, especially when you scale to the clinic. The alternative is one coherent, animal-component-free range from a single GMP manufacturer - research to GMP without switching suppliers.
Shared upstream, then three modality tracks
One shared upstream (cell bank to activation), then modality-specific tracks - cell therapy, viral vector and plasmid DNA. Choose the track for your product type.
- A1Cell Bank & ThawShared upstream.
- A2Cell Collection & IsolationShared upstream.
- A3Cell Expansion & ActivationShared upstream.
- ACell Therapy trackDownstream · cells are the product.
- BViral Vector trackDownstream · AAV / lentivirus.
- CPlasmid DNA trackDownstream · pDNA / DNA products.
- A4QC & StabilityService · across every track.
Shared upstream - common to all cell & gene therapy modalities.
A1 · Cell Bank Management & Thaw7 products
- Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP)CT-991500Thaw / dilution buffer prep.
- DPBS w/o Ca & MgP04-36500CT-36500Cell washing after thaw.
- Cryopan II, chemically defined and protein-free freezing mediumP07-93100CT-94100Cryopreservation on bank-up.
- Cryopan III, DMSO-free Freezing mediumP07-96100CT-96100DMSO-free alternative.
- Penicillin-Streptomycin, 10.000 U/ml Penicillin, 10 mg/ml StreptomycinP06-07100CT-07110Contamination protection.
- L-Glutamine 200 mMP04-80100CT-80100Medium supplementation.
- RNase/DNase Neutralizer, Nuclease Decontamination solutionP10-61500Surface / equipment decontamination.
A2 · Cell Collection & Isolation5 products
- Pancoll Human, 1.077 g/mlP04-60500Density-gradient isolation of mononuclear cells.
- HBSS, w: Ca and MgP04-32500Balanced salt wash.
- EBSS, w/o Ca and MgP04-31500Balanced salt handling.
- DPBS w/o Ca & MgP04-36500CT-36500Cell washing / resuspension.
- Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP)CT-991500Buffer preparation.
A3 · Cell Expansion & Activation7 groups
Choose per cell type / protocol - grouped by category:
Base media4 products
- DMEM, w: 4.5 g/L Glucose, w: stable Glutamine, w/o: Sodium pyruvate, w: 3.7 g/L NaHCO₃P04-04500CT-04500Classical base medium.
- RPMI 1640, w: stable Glutamine, w: 2.0 g/L NaHCO₃P04-18500CT-18500Base medium (immune cells).
- DMEM/F-12P04-41150GMP grade on requestVersatile base (stem/primary).
- IMDMP04-20450GMP grade on requestEnriched base (immune/haematopoietic).
Cell-specific media10 products
- Panserin 701 (immune cells)P04-710701GMP grade on requestSerum-free immune-cell medium.
- Pancell T Kit (T cells)P04-710414KGMP grade on requestT-cell expansion kit.
- Panserin 413P04-71413GMP grade on requestT-/CIK-/NK-cell medium.
- LymphopanP04-70700GMP grade on requestLymphocyte medium.
- ErythroPlusP04-20251KGMP grade on requestErythroid-cell kit.
- PowerStem MSC1 KitP04-77355KGMP grade on requestMSC expansion.
- Endopan 3P04-0010KGMP grade on requestEndothelial / stem-cell medium.
- Mesenpan KitP08-50400KGMP grade on requestMSC medium.
- NeuropanP04-00900GMP grade on requestNeural-cell medium.
- MarrowpanP04-70250GMP grade on requestBone-marrow medium.
Serum & serum-free supplements4 products
- Panexin CD (serum replacement)P04-93100GMP grade on requestChemically defined serum replacement.
- Panexin basic (serum replacement)P04-96900GMP grade on requestDefined serum replacement.
- Panexin NTA (serum replacement)P04-95700GMP grade on requestSerum replacement (adherent).
- Defibrinated Human Platelet Lysate (hPL)P40-28050Xeno-free growth supplement (MSC).
Feed & buffering supplements9 products
- ITS solution I (100x)P07-03100CT-03110Serum-free supplement.
- Stable Glutamine 200 mM (100x)P04-82100CT-82100Stable glutamine supplement.
- Pluronic® F-68 10 %P08-02100CT-02110Shear protection.
- Sodium bicarbonate 7,5 %P04-44100GMP grade on requestpH buffering.
- HEPES Buffer 1 MCT-01100Neutral-pH buffering.
- Insulin human rec., 10 mg/ml SolutionP07-04300Serum-free growth supplement.
- Glucose 20 % stock solutionCT-00331Energy source / feed.
- Sodium pyruvate 100 mMP04-43100CT-43100Energy supplement.
- MEM NEAA, Non Essential Amino Acid Solution (100x) w/o: L-GlutamineP08-32100CT-32100Non-essential amino acids.
Antibiotics3 products
Dissociation2 products
Cytokines & growth factors8 products
- FGF-2 human rec. (bFGF)CB-1102024bFGF - stem/endothelial expansion.
- IL-2 human rec.CB-2130203T-/NK-cell proliferation.
- IL-15 human rec.CB-2131500T-/NK-cell activation.
- SCF human rec.CB-1110000Stem-cell factor (HSC/stem).
- TGF-beta 1 human rec.CB-1111131MSC / regulatory-cell function.
- EGF human rec.CB-1101001Epithelial-/stem-cell proliferation.
- LIF human rec.CB-1106001Stem-cell self-renewal.
- HGF human rec.CB-1108002Regenerative / epithelial growth.
By modality - the downstream path depends on the product type. Choose the relevant track.
Track A · Cell Therapy (cells are the product)4 steps
CAR-T, TIL, NK, MSC and similar - the cells themselves are the drug product. No lysis, nuclease or chromatography; focus on activation, expansion, washing, formulation and cryopreservation.
A-A1 · Genetic modification / Transduction5 products
For engineered cell therapies (e.g. CAR-T), cells are activated and transduced with the therapeutic viral vector (produced via Track B) or modified by non-viral methods. Full expansion media and supplements are shared - see A3 · Cell Expansion & Activation.
- Pancell T Kit (T cells)P04-710414KGMP grade on requestT-cell activation / transduction medium.
- IL-2 human rec.CB-2130203T-cell activation cytokine.
- IL-15 human rec.CB-2131500T-/NK-cell activation cytokine.
- Transfection reagenton requestPAN transfection reagent on request; for non-viral gene modification.IVT Reaction Buffer 10xCT-14100IVT reaction buffer for mRNA / guide-RNA payload (transient CAR mRNA, CRISPR gRNA).
- Universal Electroporation / Nucleofection BufferCT-34100Low-conductivity electroporation/nucleofection buffer - PAN product on request; for non-viral gene modification.
A-A2 · Harvest & Wash (cells = product)4 products
- DPBS w/o Ca & Mg, GMP gradeCT-36500Cell washing (no lysis).
- HBSS, w: Ca and MgP04-32500Balanced salt wash.
- Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP)CT-991500Buffer prep.
- 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.
A-A3 · Formulation6 products
- Recombinant human serum albumin (rHSA)CT-27500Animal-free cell stabiliser.
- DPBS w/o Ca & Mg, GMP gradeCT-36500Excipient-grade base.
- Sodium chloride solution 0,9 %, GMP gradeCT-39500Physiological diluent. 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.
- Sucrose 30 % stock solutionCT-00131Cryo-stabiliser.
- Trehalose 30 % stock solutionCT-00231Stabiliser.
A-A4 · Fill & Cryopreservation4 products
- Cryopan II, chemically defined and protein-free freezing mediumP07-93100CT-94100Cryopreservation.
- Cryopan III, DMSO-free Freezing mediumP07-96100CT-96100DMSO-free cryopreservation.
- Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP)CT-991500Fill 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.
Track B · Viral Vector / Gene Therapy (AAV, lentivirus)9 steps
The vector is the product. Full downstream: production, lysis, nuclease, clarification, affinity capture, polishing / full-empty capsid separation, UF/DF, formulation and fill.
A-B1 · Vector Production / Transfection8 products
- Panserin 293A, Serum-free medium for HEK-Cells in adherent culture, w: L-GlutamineP04-710608GMP grade on requestAdherent HEK293 vector production.
- Panserin 293S, Serum-free medium for HEK-Cells in suspension culture, w: L-GlutamineP04-710609GMP grade on requestSuspension HEK293 vector production.
- L-Glutamine 200 mMP04-80100CT-80100Supplementation.
- Pluronic® F-68 10 %P08-02100CT-02110Shear protection.
- 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.
- Transfection reagenton requestPAN transfection reagent on request; required for HEK293 transfection.
- M199 w: EBSS, w: L-Glutamine, w: 2.2 g/L NaHCO₃P04-07050CT-07050Adherent producer-cell substrate for viral vector production.
- MEM Eagle w: EBSS, w: L-Glutamine, w: 2.2 g/L NaHCO₃P04-08500CT-08500Adherent producer-cell substrate for viral vector production.
A-B2 · Harvest & Lysis3 products
- PANclear Octoxynol 10% SolutionCT-01001RUO - research onlyDetergent lysis.
- PANclear APG 10% SolutionCT-01101GMP - productionAnimal-free detergent.
- 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.
A-B3 · Nuclease Treatment3 products
- Endonuclease Solutionon requestBroad-range host-cell / residual DNA-RNA clearance.
- DNase IP60-37780100Complementary DNA digestion / viscosity reduction.
- Magnesium Chloride 1 MCT-75100Nuclease cofactor.
A-B4 · Clarification3 products
A-B5 · Capture / Affinity5 products
A-B6 · Polishing / IEX (full/empty capsid)6 products
A-B7 · Ultrafiltration / Diafiltration5 products
A-B8 · Formulation14 products
- Sucrose 30 % stock solutionCT-00131Cryo-/lyo-stabiliser.
- Trehalose 30 % stock solutionCT-00231Stabiliser.
- Glycerol 20 % (v/v)CT-00901Cryoprotectant.
- Recombinant human serum albumin (rHSA)CT-27500Animal-free stabiliser.
- Mannitol 10 % (w/v)CT-00401Bulking agent.
- Polysorbate 20 (PS20) 1 %CT-00211Aggregation protection.
- Polysorbate 80 (PS80) 1 %CT-00311Aggregation protection.
- Sodium citrate, neutral (~pH 6.5)CT-62310Neutral-citrate storage buffer.
- L-Arginine 1 M, pH 7.0CT-69520Aggregation suppression.
- Histidine 100 mMCT-69510Formulation buffer.
- EDTA 0.5 M, pH 8.0CT-10500Chelation.
- DPBS w/o Ca & Mg, GMP gradeCT-36500Excipient-grade base.
- Sodium chloride solution 0,9 %, GMP gradeCT-39500Physiological diluent. 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.
Track C · Plasmid DNA (pDNA)5 steps
Starting material for transfection and a product in its own right. Alkaline lysis, neutralisation, clarification, chromatography and UF/DF. Note: pDNA is produced by E. coli fermentation - a bacterial upstream, separate from the shared mammalian cell culture; PAN covers the pDNA downstream shown here.
A-C1 · Alkaline Lysis2 products
A-C2 · Neutralisation2 products
A-C3 · Clarification2 products
A-C4 · Chromatography4 products
A-C5 · Ultrafiltration / Diafiltration3 products
Across every track
A4 · 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.
Serum-free, xeno-free - from research to GMP
For cell and gene therapies, the ancillary materials are part of the product's safety and regulatory profile. PAN-Biotech supplies animal-component-free media, cytokines and reagents that scale from first research runs to clinical GMP manufacturing - without switching suppliers.
A handful of stocks, reused across the process
Rather than a separate finished buffer for every step, a cell & gene therapy 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.
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.
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 paperFrequently asked questions
Does PAN-Biotech cover the whole cell-and-gene-therapy process?
Yes. PAN-Biotech supplies media, supplements, buffers and stock solutions across every step of a typical cell & gene therapy process - four upstream (cell-bank thaw, cell collection & isolation, cell expansion & activation, vector production / transfection) and eight downstream (harvest & lysis, nuclease treatment, clarification, capture / affinity, polishing / IEX, ultrafiltration / diafiltration, formulation, and fill & cryopreservation), followed by final QC & stability testing.
Are the products GMP grade?
The core range is catalogue GMP (CT article numbers), manufactured by PAN-Celltech; some established items are available as GMP on request, and a few are new portfolio additions. DPBS and WFI Beyond are additionally backed by filed FDA Drug Master Files.
Are the materials animal-component-free (xeno-free)?
Yes - PAN-Biotech offers serum-free and xeno-free (animal-component-free) media, serum replacements, cytokines and reagents. For an advanced therapy these ancillary materials are part of the product safety and regulatory profile; GMP grade is available on request, and many items ship RUO with a GMP path - so you need not switch suppliers between development and clinical manufacturing.
Can the downstream buffers be supplied 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.
Which cell platforms are covered?
The upstream range covers the cell-therapy and viral-vector platforms - immune cells, stem/mesenchymal cells and HEK293 - with serum-free and xeno-free media, cytokines and supplements; the downstream range is platform-independent and follows the standard capture, polishing and formulation train.