One Foundation for Cell & Gene Therapy
One qualified, serum-free and xeno-free toolkit for the whole process - a shared upstream, then the cell-therapy, viral-vector and plasmid-DNA tracks - from research grade to custom GMP on the identical products.
Cell & gene therapy inverts the economics of a biologic. Batches are small and often autologous, a batch can be a single patient's dose, and the product is living cells or a vector that goes into the patient - so whatever the inputs carry goes in with it and cannot be purified or depyrogenated out afterward. That makes the quality of the media, buffers and water a direct patient-safety question, not a procurement one. This briefing shows how one coherent, serum-free range covers the entire process, and how the water underneath it - WFI Beyond, nuclease-free and ultra-low in endotoxin - is the single input where the stakes are highest. A process built this way carries the mark Built on WFI Beyond.
Built on WFI Beyond the mark for the water beneath a therapy that earns it.
In-Depth · Industry Edition A03 · Rev 1.0 · 3 Oct 2026 · Author: Jens Hartmann, CEO, PAN-Biotech & PAN-Celltech · a briefing for pharma, biotech & CDMO teams.
Key takeaways
- Cell & gene therapy inverts the usual economics: tiny, often autologous, patient-specific batches where a batch can be one patient's dose - so a failed input is not a lost batch, it can be a patient who misses a therapy.
- The product is living cells or a vector that goes into the patient. There is no terminal purification of a cell therapy, so whatever the inputs carry goes into the final product - input quality is patient safety, directly.
- The process is one shared upstream (cell bank & thaw, collection/isolation, expansion/activation, vector production/transfection) that branches into three tracks: cell therapy (the cells are the product), viral vector / gene therapy (full AAV/LV downstream) and plasmid DNA.
- PAN covers it with one serum-free, xeno-free range - media for immune, stem, mesenchymal and neural cells, cytokines and growth factors, HEK293 vector-production media, and the buffers and stock solutions for the downstream - research grade today, the identical products custom GMP on request with no reformulation.
- Water is the sharpest input. WFI Beyond is nuclease-free (RNase and DNase not detected) so it cannot degrade a plasmid, RNA or vector genome; endotoxin more than 50x below the limit (spec < 0.005 EU/mL) so no pyrogen is carried into the cell product; sterile, animal-component-free, with all 24 ICH Q3D elemental impurities measured by ICP-MS on every lot.
- DPBS and WFI Beyond are backed by filed FDA Type IV (excipient) DMFs (MF044371, MF044505), referenceable through a Letter of Authorization - months off the filing critical path.
- Delivered by a GMP operation proven at commercial scale - up to ~1.8M L/year capacity, ~150,000 L over ~2 years with zero rejections - and recognised among Pharma Tech Outlook's Top 10 CMOs in Europe (2024). A process built this way is Built on WFI Beyond.
The cell & gene therapy process, on one foundation
One shared upstream, three modality tracks, one serum-free range - qualify once and carry it from the patient's cells to the final, cryopreserved dose.
Where the cost and the risk sit in a cell & gene therapy
In antibody manufacturing the cost and the risk have moved downstream, into a long purification train. Cell & gene therapy is different in kind. Here the batch is small and often autologous - made from one patient's own cells, for that one patient - so there is no large lot to average a deviation across, and a failed batch is not simply remade: it can mean a patient who misses a treatment window. The value and the risk are concentrated not in a step, but in the irreplaceability of the material.
And the product is unlike a molecule. A cell therapy is living cells; a gene therapy is a vector or a plasmid that will be introduced into cells. Either way, the therapeutic goes into the patient, and there is no terminal sterilisation and no final purification that can strip out what the process put in. Whatever an input carries - an endotoxin, a trace of a nuclease, a contaminant - travels with the product into the patient. That reframes every media bottle, every buffer and above all the water: in cell & gene therapy, input quality is patient safety, measured directly.
There is no step at the end that rescues a bad input. In cell & gene therapy, the quality you buy is the quality the patient receives.
Section 2One shared upstream, then three tracks
The process can be written as thirteen steps. The first four are a shared upstream common to every modality; the process then branches into three tracks. In cell therapy the cells are the product, so after modification the route is harvest and wash, formulate, fill and cryopreserve - there is no lysis, no nuclease digestion and no chromatography, because there is no molecule to purify out of the cells. In viral-vector / gene therapy (AAV, lentivirus) and plasmid DNA, the product is released from the cells and runs a full downstream - lysis, nuclease treatment, clarification, capture, polishing, concentration and formulation. PAN supplies the process liquids for every step of all three.
| Step | Stage | What happens |
|---|---|---|
| Shared upstream (USP) · every modality | ||
| S1 | Cell bank & thaw | Thaw of MCB/WCB, DMSO handling, washing and viability check. |
| S2 | Cell collection / isolation | Density-gradient separation and washing of primary cells (PBMC, MNC). |
| S3 | Cell expansion / activation | Expansion and activation of immune, stem and mesenchymal cells on serum-free media with cytokines. |
| S4 | Vector production / transfection | HEK293 transfection for AAV / lentiviral vector production; plasmid (pDNA) supply. |
| Downstream (DSP) · viral vector / gene therapy & plasmid DNA · (cell therapy branches - see note) | ||
| S5 | Harvest & lysis | Cell harvest; lysis to release the vector or plasmid (alkaline lysis for pDNA). Cell therapy: harvest & wash, no lysis. |
| S6 | Nuclease treatment | Broad-range endonuclease digests host-cell and residual DNA. Not used in cell therapy. |
| S7 | Clarification | Depth filtration → 0.2 µm; clarified vector or plasmid stream. |
| S8 | Capture / affinity | AAV/LV affinity or ion-exchange capture; plasmid capture. |
| S9 | Polishing / IEX | Charge/size polishing; full/empty capsid separation for viral vectors. |
| S10 | UF/DF | Concentration and buffer exchange into the formulation buffer. |
| S11 | Formulation | Final formulation; cryoprotectants and stabilisers (glycerol, sucrose, trehalose, rHSA, poloxamer). |
| S12 | Fill & cryopreservation | Fill - down to custom 1 mL vials - and cryopreservation (Cryopan II / III). |
| Across all tracks | ||
| S13 | QC & stability | Endotoxin, sterility, residual nuclease, identity and potency; ICH Q1A stability; DMF-backed support. |
Reading the branch. Cell therapy runs the shared upstream (S1-S4), then genetic modification / transduction, harvest and wash, formulation (S11), fill and cryopreservation (S12), and QC (S13) - it skips the lysis, nuclease and chromatography steps (S5-S10), because the cells are the product and nothing is being purified out of them. Viral-vector / gene therapy and plasmid DNA run the full downstream.
Section 3One serum-free foundation - a handful of recurring stocks
Beneath the three tracks is a single, coherent range. Its upstream half is built on serum-free and xeno-free media - defined serum replacements (Panexin CD / basic / NTA), human platelet lysate instead of foetal serum, and dedicated media for immune cells (Panserin, Pancell T, Lymphopan), stem and mesenchymal cells (PowerStem MSC1, Mesenpan, Endopan), neural cells (Neuropan) and haematopoietic cells (Marrowpan, ErythroPlus), with recombinant human cytokines and growth factors (IL-2, IL-15, FGF-2, SCF, TGF-β1, EGF, LIF, HGF). Its downstream half is built, exactly as the antibody and downstream editions describe, from a small set of concentrated stock solutions that recur again and again.
The recurrence is the economy. Across the thirteen steps, WFI-quality water is the base of ten of them and DPBS recurs in eight, from cell washing through to downstream buffers; Tris, NaCl 5 M, histidine, glycerol and the cryo/stabiliser excipients each serve several steps. Qualify a handful of stocks once, and they carry across the whole process - fewer SKUs to qualify, full flexibility to prepare working buffers, and one consistent chemistry from the bench to the clinic.
Serum-free, xeno-free - from research to GMP
Every upstream medium in the range is offered research-grade today, and the identical product is available custom GMP on request, with no reformulation. So the media a team screens, selects and optimises its cells on is the media it scales and files with - no serum to remove, no xenogeneic components to justify to a regulator, and no comparability gap opening up when a programme crosses from research into GMP. Research today, GMP tomorrow, on the same defined chemistry.
Delivered as process bundles - one box per step
PAN delivers the range the way the process runs it - as step-specific process bundles, one box per step, each holding the exact set of liquids that step needs, every bottle labelled with its name, article number, lot, volume, storage and production date. A team orders the bundle for its process step - the Cell Expansion Bundle, the Vector Production Bundle, the Nuclease & Clarification Bundle, the Formulation & Fill Bundle - rather than assembling a catalogue list and reconciling it on receipt. The shared upstream bundles are research-grade today, custom GMP on request; the downstream buffer bundles are GMP grade, and any buffer in them can be produced on the WFI Beyond water base as an added safety standard (Section 7). Full component-and-article-number listings are in Appendix A.
Section 5Upstream: from the patient's cells to an activated culture
The shared upstream takes cells from the bank or the patient into an expanded, activated culture. Cell bank & thaw (S1) runs on WFI-quality water and DPBS with Cryopan II / III for cryopreservation (DMSO and DMSO-free). Collection / isolation (S2) separates primary mononuclear cells on Pancoll density-gradient medium with HBSS/EBSS balanced-salt washes. Expansion / activation (S3) is where the serum-free range does its work: Panserin 701 and Pancell T for immune and T cells, PowerStem MSC1 and Mesenpan for mesenchymal cells, Neuropan for neural cells, the Panexin serum replacements and human platelet lysate in place of foetal serum, and the recombinant cytokines (IL-2, IL-15, FGF-2 and the rest) that drive proliferation and activation - with Accutase for gentle dissociation and the stocks that buffer and protect the culture.
Vector production (S4) adds the HEK293 route for gene therapy: Panserin 293A / 293S serum-free media for adherent and suspension HEK293, with glutamine and poloxamer shear protection, for AAV and lentiviral vector production and plasmid supply. Underneath all of it run the two universal utilities - WFI-quality water for every preparation and DPBS for washing and resuspension - so the upstream already shares its foundation with the downstream that follows.
Section 6Downstream: releasing and purifying a vector or plasmid
For viral vector and plasmid programmes, the downstream begins where cell therapy stops. Harvest & lysis (S5) releases the vector or plasmid from the cells - alkaline lysis (NaOH, SDS, potassium acetate) for plasmid DNA. Nuclease treatment (S6) then digests host-cell and residual DNA with a broad-range endonuclease and its magnesium cofactor - a step whose job is precisely to remove nucleic-acid contaminants, which is why the water it runs on must itself be nuclease-free. Clarification (S7) filters the stream; capture (S8) takes the vector or plasmid onto an affinity or ion-exchange resin on a Tris/NaCl base; polishing (S9) separates on phosphate/acetate bases - for viral vectors, the all-important full/empty capsid separation; UF/DF (S10) concentrates and exchanges into the formulation buffer.
Formulation (S11) stabilises the product for storage with the excipients cell & gene therapies rely on - glycerol, sucrose, trehalose, recombinant human albumin, poloxamer - and fill & cryopreservation (S12) fills to dose, down to custom 1 mL vials sized to a single manufacturing run, and cryopreserves. One qualified set of stocks carries the whole downstream, and every buffer in it can be built on WFI Beyond.
Section 7Water, and why it matters most here
Water is the base of every medium, buffer and final formulation, so it sets the quality ceiling for the whole process. In cell & gene therapy that ceiling is not an abstraction: because there is no terminal purification, the water's quality is carried into the patient. And the pharmacopoeial Water for Injection monograph (Ph. Eur. 0169, its core dating to 1969) was never written for this - it limits conductivity, organic carbon and endotoxin, and is silent on the two attributes that decide a gene-therapy input: nuclease activity and trace metals. WFI Beyond starts from that gap.
What WFI Beyond is. WFI Beyond is PAN's beyond-compendial Water for Injection - water that first meets the monograph and then goes past it, proven lot by lot on the Certificate of Analysis:
- Nuclease-free - RNase and DNase not detected. This is the attribute that matters most in gene therapy: a residual nuclease in the water would attack the very plasmid, RNA or vector genome that is the therapy. The monograph does not test for it.
- Endotoxin more than 50x below the compendial limit (spec < 0.005 EU/mL) - because endotoxin carried into a cell product cannot be removed afterward, and ex vivo cell culture leaves no margin.
- Sterile (0.1 µm filtered, filled into gamma-irradiated single-use containers) and animal-component-free, with a signed BSE/TSE and ICH Q3 declaration.
- All 24 ICH Q3D elemental impurities specified and measured by ICP-MS on every lot - a first for a water, since the monograph tests none of them.
- DMF-backed - a filed FDA Type IV (excipient) Drug Master File (MF044505), referenceable in an IND/BLA through a Letter of Authorization.
Why it matters for a cell or gene therapy. The two inputs most capable of silently harming an advanced therapy are a residual nuclease - which degrades the nucleic-acid payload - and endotoxin, which travels into the patient with a product that cannot be depyrogenated. WFI Beyond is engineered against exactly those two. Controlling the water controls them at the source, upgrading every medium and buffer built on it. (The full water story is In-Depth · Industry Edition D02 · Water: The WFI Beyond Standard.)
Built on WFI Beyond the mark for the water beneath a therapy that earns it.
Built on WFI Beyond
Because every medium and buffer in the range is built on a water base, the same upgrade is open to all of them. On request, the buffers for any step - or the whole process - can be produced on the WFI Beyond water base instead of standard WFI-quality water, giving the finished liquids the same nuclease-free, ultra-low-endotoxin, metal-controlled foundation. For a clinical cell or gene therapy, this is the recommended safety standard: it removes the two inputs most likely to harm the product, at the layer where it is cheapest to control.
How to get it. The WFI Beyond upgrade is opt-in and made to order - produced through PAN-Celltech's Custom Solutions / custom GMP program, with a Certificate of Analysis per lot and DMF-backed regulatory support, in formats from custom 1 mL vials up to 1000 L. Ask your PAN contact to build any step, or the whole process, Built on WFI Beyond.
The DMF advantage
Two of the universal utilities are backed by filed FDA Type IV Drug Master Files - DPBS (MF044371) and WFI Beyond (MF044505). Type IV is the FDA's category for excipients, which is what these materials are in a finished cell or gene therapy, so you reference them in your IND/BLA through a Letter of Authorization rather than re-proving or reconstructing them - taking months of independent testing off the critical path, with PAN's proprietary detail protected in the FDA's confidential file. (DMF and stability support are optional, on-request services.)
Section 9The proof - and a cell & gene therapy case
The GMP liquids are filled by the PAN-Celltech GMP operation that has proven itself at commercial scale - GMP-compliant and audit-proven manufacture in an EU Annex 1 facility (a capability, not a certification):
A representative case: a CAR-T developer needed the highest-quality water to dilute a plasmid before electroporating human T cells - and PAN-Celltech supplied WFI Beyond custom-filled into 1 mL vials, one vial per manufacturing run, for an early-phase programme - read the anonymised story, WFI Beyond in 1 mL vials for clinical CAR-T manufacturing, in the Knowledge Hub. Track-record figures are anonymised; capacity figures are stated as "up to".
The input that reaches the patient unfiltered
Across the interviews behind this series, one fear is specific to advanced therapies: that a developer does everything right in the clinic and is undone by something the process carried in - because here, uniquely, there is no purification at the end to catch it. A trace of a nuclease that quietly nicks a plasmid and drops a batch's potency; an endotoxin that a molecule could have been polished away from, but a living cell product cannot; a contaminant that in an antibody train would never have survived to the vial.
That is why, for a cell or gene therapy, the media and the water are not commodities to be bought on price. They are the parts of the process that reach the patient least changed. Controlling them up front - serum-free and xeno-free media that scale to GMP without a comparability gap, and water that is nuclease-free and ultra-low in endotoxin before it ever touches a cell - is among the cheapest insurance an advanced-therapy programme can buy against its most expensive kind of failure.
- A personal note from the author, drawn from the interview programme behind this In-Depth series.
What the one-foundation approach means for you - by function
The story above is shared. The sections below translate it into the terms of a specific role - read yours, skip the rest.
Develop the whole therapy on one serum-free foundation
A cell or gene therapy process touches isolation media, a dozen serum-free expansion media and supplements, cytokines, vector-production media and - for vector and plasmid work - a full set of downstream buffers. Assembled from a scattered supplier base, each carries its own qualification and its own xenogeneic-component justification. PAN lets you build the whole thing on one coherent, serum-free and xeno-free range, and - because every upstream medium scales to the identical GMP product with no reformulation - the material you optimise your cells on is the material you file with. No serum to remove late, no comparability gap to close.
The chemistry is built for how advanced therapies behave - defined serum replacements and human platelet lysate instead of foetal serum, dedicated media for immune, stem, mesenchymal and neural cells, recombinant cytokines for activation, and a downstream of recurring stocks for vector and plasmid work - and every buffer can be built on WFI Beyond where a fragile payload earns it. (See the cell & gene therapy toolkit in the Knowledge Hub.)
Ready-made media and buffers - fewer open events in a sterile suite
On the floor of a cell & gene therapy suite, every manual preparation is an open event in an aseptic process - and the batch is irreplaceable. Ordering the media, supplements and buffers ready-to-use, in GMP grade with a CoA per lot, in one packaging standard from a single qualified source, takes weighing, mixing and QC-checking off the floor and removes contamination entry points at the stage where contamination cannot be filtered out later. And you can order them by the process step - as a bundle, one labelled box carrying exactly what that step needs - instead of picking each item off a catalogue line.
It also fits how advanced therapies are dosed. Custom fills down to 1 mL vials mean one ready-to-use unit per manufacturing run - no opening a large container for a fraction of a millilitre, no carry-over between patients - and on-stock dispatch keeps a patient-scheduled campaign from waiting on a custom-manufacturing slot.
Qualify one serum-free range, not a fragmented basket
Because a handful of universal stocks and a single serum-free media range cover the whole process, you qualify and carry far fewer SKUs than a product-by-product basket implies - fewer vendors, fewer audits, one documentation and packaging standard. The right lens is total cost of ownership, where for an advanced therapy the hidden tail is dominated by the cost of a lost, irreplaceable batch and the qualification burden of xenogeneic materials - both of which a single serum-free, GMP-grade, DMF-supported source collapses.
Held stock is insurance against a patient-driven schedule you cannot forecast. The reliability is proven: an entire specialty portfolio bridged at ~150,000 L over ~2 years with zero rejections (see the Knowledge Hub). And key inputs are DMF-supported today, turning a sourcing decision into a regulatory asset.
One audited source, and the attributes advanced therapies are judged on
Consolidating media, supplements, buffers and utilities to one audited GMP source collapses the QA load a fragmented advanced-therapy supply creates - a single set of documentation and specifications, one packaging standard, one EU Annex 1 site to assess on-site or remotely, in full or in part, with a Certificate of Analysis on every lot. And because DPBS and WFI Beyond are excipients in the finished product, that documentation is already on file with the FDA as a Type IV (excipient) DMF your regulatory team can reference.
The attributes that matter here are built in and documented: a serum-free, xeno-free position with a signed BSE/TSE declaration answering the adventitious-agent question up front; nuclease-free, ultra-low-endotoxin water on the Certificate of Analysis; and the modern impurity classes (ICH Q3D elemental impurities, residual solvents, nitrosamines) documented ahead of the questions. Stability support is available on request.
Reference our filings; answer the advanced-therapy questions once
The two universal utilities most likely to sit in a cell or gene therapy submission - DPBS and WFI Beyond - are backed by filed FDA Type IV (excipient) Drug Master Files (MF044371, MF044505). You cross-reference them through a Letter of Authorization, so the water and the wash/formulation base are referenceable as exactly what they are in the product, without rebuilding a dossier or re-proving the material - months off the critical path.
Because one serum-free range carries the process from research to GMP on the identical chemistry, the material named in your control strategy is consistent from the patient's cells to the final dose, and the beyond-compendial dossier - serum-free / xeno-free with a signed BSE/TSE declaration, plus ICH Q3D, Q3C and nitrosamine assessment - answers the questions an advanced-therapy filing draws before they are asked. Where a specific product you rely on is not yet filed, PAN-Celltech will write and file a custom DMF on request.
Compress the timeline; de-risk an irreplaceable batch
For the fastest-growing, highest-value modality in the industry, time to clinic and batch reliability are the asset. One qualified, serum-free range across the whole process - research grade today, the identical GMP material tomorrow - plus DMF-backed references takes weeks-to-months out of qualification and filing and removes the serum-to-GMP comparability work that quietly slows an advanced-therapy programme.
The larger prize is de-risking a batch that cannot be remade. Removing the avoidable failure modes a fragmented, under-documented, serum-containing supply invites - an adventitious-agent finding, a nuclease or endotoxin surprise, a supply gap against a patient's schedule - is exactly the CMC and supply-chain diligence investors and partners look for in cell & gene therapy. It reframes PAN from a vendor of liquids into a partner that takes time and risk out of the path to the patient, backed by external recognition (Pharma Tech Outlook's "Top 10 CMOs in Europe", 2024) and a proven continuity record.
A serum-free toolkit you can run - and offer to your clients
For a contract manufacturer running many advanced-therapy programmes, one qualified, serum-free range - media and supplements upstream, buffers and stocks downstream, all with a CoA per lot - lets you standardise incoming materials across every client rather than re-qualifying a different media and buffer set, with its own xenogeneic-component file, for each. And because DPBS and WFI Beyond are filed as Type IV (excipient) DMFs your clients can reference directly, it is a regulatory asset you pass straight through to the sponsor.
As a capacity partner, PAN-Celltech runs custom-formulated GMP (EU Annex 1) production, including private-label lines and custom single-use fill from 1 mL to 1000 L, with scale to match - combined output up to ~1.8 million litres a year - and a continuity record to underwrite it. The same serum-free GMP material serves a client's programme from early development through to commercial supply.
In one arc
One shared upstream, then three tracks - cell therapy, viral vector, plasmid DNA → a serum-free, xeno-free media range for immune, stem, mesenchymal and neural cells → the downstream stocks for vector and plasmid work → research grade today, the identical products custom GMP with no reformulation → water engineered beyond the monograph, nuclease-free and ultra-low in endotoxin → DMF-backed regulatory confidence. One foundation for the whole therapy, from a single partner whose reason for building it is to take risk and time out of your path to the patient.
What to ask your PAN contact for
The cell & gene therapy toolkit specification, a representative Certificate of Analysis, a DMF Letter of Authorization, and the water story behind the safety standard.
Downstream buffer bundles are GMP grade, manufactured by PAN-Celltech; the shared upstream media are research-grade today, the same products custom GMP on request with no reformulation. Human platelet lysate and recombinant cytokines are supplied research-grade (no GMP). Manufactured to GMP in an EU Annex 1 facility (a capability, not a certification). WFI Beyond is opt-in, for further manufacturing / as an excipient.
The cell & gene therapy toolkit - by process step
Key products by step, with article numbers. The shared upstream (S1-S4) media are research-grade (P- numbers) unless shown as GMP - the same products available custom GMP on request with no reformulation; the downstream buffers (S5-S12) are GMP (CT- numbers). Every buffer is available beyond-compendial, produced with WFI Beyond (CT-981500) instead of standard WFI, on request. Pack sizes and article numbers are verified against PAN datasheets, Catalogue 03/2026 and the webshop.
| Step | Key product | Article no. |
|---|---|---|
| Shared upstream (USP) · S1-S4 · serum-free / xeno-free, research grade (custom GMP on request) | ||
| S1 · Cell bank & thaw | WFI Quality Water (GMP) | CT-991500 |
| DPBS w/o Ca & Mg (GMP) | CT-36500 | |
| Cryopan II, with DMSO (GMP) | CT-94100 | |
| Cryopan III, DMSO-free (GMP) | CT-96100 | |
| Penicillin-Streptomycin (GMP) | CT-07110 | |
| L-Glutamine 200 mM (GMP) | CT-80100 | |
| RNase/DNase Neutralizer | P10-61500 | |
| S2 · Cell collection / isolation | Pancoll Human 1.077 g/ml | P04-60500 |
| HBSS w: Ca & Mg | P04-32500 | |
| EBSS w/o Ca & Mg | P04-31500 | |
| DPBS w/o Ca & Mg (GMP) | CT-36500 | |
| WFI Quality Water (GMP) | CT-991500 | |
| S3 · Cell expansion / activation | Panserin 701 (immune cells) | P04-710701 |
| Pancell T Kit (T cells) | P04-710414K | |
| Panserin 413 (lymphocytes) | P04-71413 | |
| Lymphopan | P04-70700 | |
| ErythroPlus (erythroid) | P04-20251K | |
| PowerStem MSC1 Kit (MSC) | P04-77355K | |
| Endopan 3 Kit (endothelial) | P04-0010K | |
| Mesenpan Kit (MSC, xeno-free) | P08-50400K | |
| Neuropan (neural) | P04-00900 | |
| Marrowpan (bone marrow) | P04-70250 | |
| DMEM w: stable Gln (GMP) | CT-04500 | |
| RPMI 1640 w: stable Gln (GMP) | CT-18500 | |
| DMEM/F-12 | P04-41150 | |
| IMDM | P04-20150 | |
| Panexin CD (serum replacement) | P04-93100 | |
| Panexin basic (serum replacement) | P04-96900 | |
| Panexin NTA (serum replacement) | P04-95700 | |
| hPL def b (human platelet lysate) | P40-28050 | |
| ITS Solution I | P07-03100 | |
| Stable Glutamine 200 mM | P04-82100 | |
| IL-2 human rec. | CB-2130203 | |
| IL-15 human rec. | CB-2131500 | |
| FGF-2 human rec. (bFGF) | CB-1102024 | |
| SCF human rec. | CB-1110000 | |
| TGF-β1 human rec. | CB-1111131 | |
| EGF human rec. | CB-1101001 | |
| LIF human rec. | CB-1106001 | |
| HGF human rec. | CB-1108002 | |
| Accutase (dissociation) | P10-21500 | |
| Trypsin 0.05 % / EDTA 0.02 % in DPBS | P10-029100 | |
| Gentamicin Sulfate 10 mg/ml | P06-03050 | |
| Amphotericin B 250 µg/ml | P06-01050 | |
| Pluronic F-68 10 % | P08-02100 | |
| Sodium Bicarbonate 7.5 % | P04-44100 | |
| HEPES Buffer 1 M (GMP) | CT-01100 | |
| S4 · Vector production / transfection | Panserin 293A (adherent HEK293) | P04-710608 |
| Panserin 293S (suspension HEK293) | P04-710609 | |
| L-Glutamine 200 mM (GMP) | CT-80100 | |
| Pluronic F-68 10 % | P08-02100 | |
| WFI Quality Water (GMP) | CT-991500 | |
| Transfection reagent (PEI) | coming soon | |
| Downstream (DSP) · S5-S12 · GMP buffers & stock solutions (viral vector / plasmid; cell therapy uses S11-S12 only) | ||
| S5 · Harvest & lysis | NaOH 1 M Stock | CT-55105 |
| SDS 10 % | CT-06500 | |
| Potassium acetate 3 M | CT-76500 | |
| Tris Buffer 1 M | CT-05500 | |
| WFI Quality Water | CT-991500 | |
| S6 · Nuclease treatment | Broad-range endonuclease (article under revision) | on request |
| Magnesium Chloride 1 M (cofactor) | CT-75100 | |
| Tris Buffer 1 M | CT-05500 | |
| WFI Quality Water | CT-991500 | |
| S7 · Clarification | DPBS w/o Ca & Mg | CT-36500 |
| NaCl 5 M Stock | CT-77055 | |
| WFI Quality Water | CT-991500 | |
| S8 · Capture / affinity | Tris Buffer 1 M | CT-05500 |
| NaCl 5 M Stock | CT-77055 | |
| Phosphate Buffer 100 mM | CT-18810 | |
| Sodium acetate 100 mM | CT-76451 | |
| WFI Quality Water | CT-991500 | |
| S9 · Polishing / IEX | Phosphate Buffer 100 mM | CT-18810 |
| NaCl 5 M Stock | CT-77055 | |
| Ammonium Sulfate 1 M | CT-67500 | |
| Ammonium Sulfate 3 M | CT-68500 | |
| Citrate Buffer 100 mM | CT-62500 | |
| Glycine 100 mM | CT-69500 | |
| WFI Quality Water | CT-991500 | |
| S10 · UF/DF | Histidine 100 mM | CT-69510 |
| Phosphate Buffer 100 mM | CT-18810 | |
| NaCl 5 M Stock | CT-77055 | |
| Sodium citrate neutral 100 mM | CT-62310 | |
| DPBS w/o Ca & Mg | CT-36500 | |
| WFI Quality Water | CT-991500 | |
| S11 · Formulation | Glycerol 20 % | CT-00901 |
| Sucrose 30 % | CT-00131 | |
| Trehalose 30 % | CT-00231 | |
| rHSA 20 % | CT-27500 | |
| Mannitol 10 % | CT-00401 | |
| L-Arginine 1 M | CT-69520 | |
| Histidine 100 mM | CT-69510 | |
| EDTA 0.5 M | CT-10500 | |
| Poloxamer (Pluronic F-68 10 %) | P08-02100 | |
| WFI Quality Water | CT-991500 | |
| S12 · Fill & cryopreservation | Cryopan II, with DMSO | CT-94100 |
| Cryopan III, DMSO-free | CT-96100 | |
| Glycerol 20 % | CT-00901 | |
| rHSA 20 % | CT-27500 | |
| Custom 1 mL fill | on request | |
| WFI Quality Water / WFI Beyond | CT-991500 / CT-981500 | |
| Service · S13 | ||
| S13 · QC & stability · service | Release testing: CoA per lot, endotoxin (LAL), residual nuclease, bioburden & sterility, ICH Q1A stability, DMF / LoA | - |
Universal utilities. WFI Quality Water (CT-991500) recurs across ten steps and DPBS (CT-36500) across eight; Tris, NaCl 5 M and the cryo/stabiliser excipients serve several each. WFI Beyond (CT-981500) is Water for Injection engineered beyond Ph. Eur. monograph 0169 - nuclease-free (RNase & DNase not detected), endotoxin < 0.005 EU/mL (>50x below limit), all 24 ICH Q3D elements by ICP-MS - and, with DPBS, is backed by a filed FDA Type IV (excipient) DMF (MF044505, MF044371). The shared upstream media (S1-S4) are serum-free / xeno-free, research grade today and custom GMP on request with no reformulation; human platelet lysate and recombinant cytokines are research grade (no GMP). Full specifications and current article numbers on request.
The cell & gene therapy toolkit, answered
Why is input quality a patient-safety question in cell & gene therapy?
Because the product is living cells or a vector that goes into the patient, and there is no terminal sterilisation or final purification to strip out what the process put in. Whatever an input carries - endotoxin, a residual nuclease, a contaminant - travels with the product into the patient. So the quality of the media, buffers and water is carried through to the patient directly.
How does one toolkit cover three different modalities?
The process shares one upstream - cell bank & thaw, collection/isolation, expansion/activation and vector production/transfection - and then branches. Cell therapy (the cells are the product) runs the upstream plus modification, harvest, formulation and fill, skipping lysis, nuclease and chromatography. Viral vector / gene therapy and plasmid DNA run the full downstream. One serum-free media range and one set of recurring downstream stocks serve all three.
What does "serum-free, xeno-free - from research to GMP" mean in practice?
Every upstream medium is offered research-grade today, and the identical product is available custom GMP on request with no reformulation. There is no serum to remove and no xenogeneic component to justify to a regulator, and no comparability gap when a programme crosses from research into GMP, because the chemistry does not change.
Why does nuclease-free water matter most in gene therapy?
Because the therapeutic payload is a nucleic acid - a plasmid, an RNA or a vector genome - and a residual nuclease in the water would degrade exactly that. The pharmacopoeial Water-for-Injection monograph does not test for nuclease activity. WFI Beyond is nuclease-free: RNase and DNase are not detected, so the water cannot attack the payload.
What does "Built on WFI Beyond" mean for a cell or gene therapy?
Every medium and buffer is built on a water base, so any step - or the whole process - can be produced on the beyond-compendial WFI Beyond water base instead of standard WFI. That removes the two inputs most likely to harm an advanced therapy - residual nuclease and endotoxin - at the cheapest layer to control. It is opt-in and made to order, with a CoA per lot and DMF-backed support, in formats from custom 1 mL vials up to 1000 L.
Can I reference the Drug Master File in my submission?
Yes. DPBS and WFI Beyond are backed by filed FDA Type IV (excipient) DMFs (MF044371, MF044505). You cross-reference them in your IND/BLA through a Letter of Authorization, so the material is referenceable as exactly what it is in the product without rebuilding a dossier.
Can I develop in research grade and move to GMP later?
Yes. The shared upstream media are research-grade today; the identical products ship custom GMP on request with no reformulation, across immune, stem, mesenchymal and neural cells and the HEK293 vector-production media. So the material you optimise your cells on is the material you scale and file with.