One Foundation for the Whole Antibody Process
How one GMP-grade range of media, supplements, buffers and stock solutions carries a monoclonal antibody from the cell bank to the final drug substance.
Twelve steps, one coherent range
A monoclonal-antibody process passes through twelve defined process steps - five upstream, seven downstream - plus a final QC and stability step, and every one of them needs its own media, supplements or buffers. Sourced piecemeal, that becomes dozens of separate qualifications. PAN-Biotech covers the entire workflow with one GMP-grade toolkit: catalogue products at every step, a small set of 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
Making a monoclonal antibody is not one process but a chain of them - thaw and recovery, clone selection and expansion, bioreactor production, clarification, then a sequence of chromatography and membrane steps. Each consumes its own process liquids. Sourced from a scatter of suppliers, that list becomes an administrative burden: every article needs its own qualification, documentation and audit trail. The alternative is one coherent range - the same manufacturer, the same quality system, the same regulatory support - from the cell bank to the drug substance.
From cell bank to clarified harvest
Steps S1-S5 - cells from the bank to a clarified harvest.
- 1Cell Bank Management & Thaw / CryorecoveryThawing of MCB/WCB, DMSO removal, initial viability check.
- 2Screening & Selection (Hybridoma / Seed Train)Clonal expansion in T-flasks;
- 3Cell Expansion & Seed Train (CHO / HEK293 / Hybridoma)Step-wise expansion from shake flask to bioreactor inoculum.
- 4Bioreactor Production (Fed-batch / Perfusion)Production bioreactor 1-1,000 L.
- 5Harvest & ClarificationSeparation of mAb-containing supernatant from cells and debris.
S1 · Cell Bank Management & Thaw / Cryorecovery7 products
- WFI Quality WaterCT-991500Thaw buffer prep; supplement reconstitution; rinsing; Ph. Eur./USP.
- DPBS w/o Ca & MgCT-36500Cell washing after thaw; DMSO cryoprotectant removal (2-3 wash cycles)
- Cryopan II (chem. def., with DMSO)CT-94100Chem. defined cryopreservation; Ph. Eur./USP compliant; GMP cell bank.
- Cryopan III (DMSO-free)CT-96100DMSO-free alternative; sensitive cell lines or where DMSO removal is impractical.
- Penicillin-Streptomycin 10,000 U/ml + 10 mg/mlCT-07110Contamination protection during early expansion; use per protocol.
- L-Glutamine 200 mMCT-80100Supplementation if base medium lacks stable Gln; standard form for thaw media.
- RNase/DNase NeutralizerP10-61500Surface and equipment decontamination; eliminates RNase/DNase from thaw area, laminar flow hood, vessels.
S2 · Screening & Selection (Hybridoma / Seed Train)8 products
- DMEM w: stable Gln, w: 3.7 g/L NaHCO₃CT-04500Primary hybridoma clonal expansion medium; adherent culture; direct use.
- RPMI 1640 w: stable Gln, w: 2.0 g/L NaHCO₃CT-18500Lymphocyte-origin hybridomas; B-cell lines; >95% coverage together with DMEM.
- HAT Supplement 50×P07-02100CT-02100 · coming soonObligatory hybridoma selection; eliminates unfused myeloma cells.
- HT Supplement 50×P07-01100CT-03100 · coming soonPost-HAT aminopterin washout; recovery after selection phase.
- Penicillin-Streptomycin 10,000 U/ml + 10 mg/mlCT-07110Contamination prevention during clonal selection phase.
- AccutaseP10-21500Gentle cell dissociation for adherent hybridoma clones; subculture.
- DPBS w/o Ca & MgCT-36500Cell washing, ELISA wash buffer, passage buffer, dilution.
- WFI Quality WaterCT-991500Supplement reconstitution; buffer preparation.
S3 · Cell Expansion & Seed Train (CHO / HEK293 / Hybridoma)3 systems
Choose the expression system - each opens with its dedicated medium / feed, followed by the shared supplements & utilities.
CHO8 products
- PANcell CHO Feed KitP04-71102KGMP grade on requestStandard CHO seed train. Same feed/boost. DHFR- lines: add H/T.
- L-Glutamine 200 mMCT-80100Required for PANcell CHO Kits (no L-Gln); add separately. GMP grade CT-80100. A stable dipeptide alternative (Stable Glutamine 200 mM, CT-82100) is listed separately.
- Stable Glutamine 200 mM (100x), GMP gradeP04-82100CT-82100 · coming soonStable dipeptide L-alanyl-L-glutamine; no ammonia build-up; serum-free seed train.
- ITS solution I (100x)P07-03100CT-03110 · coming soonInsulin-Transferrin-Selenium; serum-free growth support during expansion.
- Pluronic® F-68 10 %, GMP gradeP08-02100CT-02110 · coming soonShear protectant in stirred bioreactors and shake flasks. Not needed for HybridBoost/ISF-1 (surfactant built in).
- Sodium Bicarbonate 7.5%P04-44100GMP grade on requestPH buffering in CO--controlled systems; standard additive for serum-free media.
- DPBS w/o Ca & MgCT-36500Cell counting; washing between passages.
- WFI Quality WaterCT-991500Buffer and supplement preparation.
HEK2939 products
- Panserin 293A (Adherent HEK293)P04-710608GMP grade on requestSerum-free medium for adherent HEK293; DMEM/F12 base; adherent expansion and seed train.
- Panserin 293S (Suspension HEK293)P04-710609GMP grade on requestSerum-free medium for suspension HEK293; DMEM/F12 base; hydrolysates <0.02% w/v; seed 5x10⁶/ml; shaker / spinner / bioreactor.
- L-Glutamine 200 mMCT-80100Required for PANcell CHO Kits (no L-Gln); add separately. GMP grade CT-80100. A stable dipeptide alternative (Stable Glutamine 200 mM, CT-82100) is listed separately.
- Stable Glutamine 200 mM (100x), GMP gradeP04-82100CT-82100 · coming soonStable dipeptide L-alanyl-L-glutamine; no ammonia build-up; serum-free seed train.
- ITS solution I (100x)P07-03100CT-03110 · coming soonInsulin-Transferrin-Selenium; serum-free growth support during expansion.
- Pluronic® F-68 10 %, GMP gradeP08-02100CT-02110 · coming soonShear protectant in stirred bioreactors and shake flasks. Not needed for HybridBoost/ISF-1 (surfactant built in).
- Sodium Bicarbonate 7.5%P04-44100GMP grade on requestPH buffering in CO--controlled systems; standard additive for serum-free media.
- DPBS w/o Ca & MgCT-36500Cell counting; washing between passages.
- WFI Quality WaterCT-991500Buffer and supplement preparation.
Hybridoma8 products
- HybridBoostCT-995905Serum-free hybridoma production. Stable Gln + recomb. insulin + 2.438 g/L NaHCO₃ + built-in surfactant. ~700k cells/ml (Sp2/0, 4d). Direct adaptation.
- L-Glutamine 200 mMCT-80100Required for PANcell CHO Kits (no L-Gln); add separately. GMP grade CT-80100. A stable dipeptide alternative (Stable Glutamine 200 mM, CT-82100) is listed separately.
- Stable Glutamine 200 mM (100x), GMP gradeP04-82100CT-82100 · coming soonStable dipeptide L-alanyl-L-glutamine; no ammonia build-up; serum-free seed train.
- ITS solution I (100x)P07-03100CT-03110 · coming soonInsulin-Transferrin-Selenium; serum-free growth support during expansion.
- Pluronic® F-68 10 %, GMP gradeP08-02100CT-02110 · coming soonShear protectant in stirred bioreactors and shake flasks. Not needed for HybridBoost/ISF-1 (surfactant built in).
- Sodium Bicarbonate 7.5%P04-44100GMP grade on requestPH buffering in CO--controlled systems; standard additive for serum-free media.
- DPBS w/o Ca & MgCT-36500Cell counting; washing between passages.
- WFI Quality WaterCT-991500Buffer and supplement preparation.
S4 · Bioreactor Production (Fed-batch / Perfusion)13 products
- PANcell CHO Feed KitP04-71102KGMP grade on requestChem. defined fed-batch production medium. Feed 5% v/v from Day 2-4; Boost 1-2% v/v from Day 3-5.
- HybridBoostCT-995905Fed-batch hybridoma production medium. Direct adaptation; no reformulation needed RUO-GMP.
- L-Glutamine 200 mMCT-80100Fed-batch L-glutamine supplementation (GMP grade, CT-80100). A stable dipeptide alternative (Stable Glutamine, CT-82100) reduces ammonia build-up in long runs.
- Glucose 20% stock solutionCT-00331Fed-batch glucose bolus feed.
- Pluronic® F-68 10 %, GMP gradeP08-02100CT-02110 · coming soonContinuous shear protection in sparged bioreactors (CHO/HEK293).
- Sodium Bicarbonate 7.5%P04-44100GMP grade on requestPH correction in bioreactor supplementary to CO- control.
- HEPES Buffer 1 MCT-01100PH stabilisation for bioreactor sampling and media handling outside incubator.
- MEM NEAA, Non Essential Amino Acid Solution (100x) w/o: L-GlutamineP08-32100CT-32100 · coming soonNon-essential amino acids; productivity enhancement in fed-batch culture.
- Insulin human recombinant 10 mg/mlP07-04300GMP grade on requestGrowth supplement; glucose uptake; metabolic support in serum-free systems.
- Sodium pyruvate 100 mMP04-43100CT-43100 · coming soonEnergy substrate; metabolic support; especially relevant for serum-free culture.
- WFI Quality WaterCT-991500Large-scale media preparation; Ph. Eur./USP.
- Stable Glutamine 200 mM (100x), GMP gradeP04-82100CT-82100 · coming soonStable Gln source for fed-batch; reduces ammonia vs. free L-Gln.
- ITS solution I (100x)P07-03100CT-03110 · coming soonSerum-free supplement; supports viability & productivity in production.
S5 · Harvest & Clarification6 products
- DPBS w/o Ca & MgCT-36500Membrane rinsing; system flush; isotonic solution.
- WFI Quality WaterCT-991500System flushing; buffer preparation for filtration.
- DPBS, (10x) w/o: Ca and MgP04-53500CT-53500 · coming soon10x concentrate; dilute 1:10 with WFI to DPBS 1x. Harvest system buffer; membrane pre-wetting, equilibration and rinsing.
- Sodium chloride solution 0,9 %P05-39500CT-39500 · coming soonIsotonic system flushing; simple wash and equilibration.
- AccutaseP10-21500Gentle adherent cell harvest without trypsin.
- RNase/DNase NeutralizerP10-61500Decontamination of harvest equipment, vessels and surfaces; eliminates RNase/DNase.
From capture to drug substance
Steps S6-S12 - the harvest to a formulated drug substance; step 13 (QC & stability) is quality control, not a DSP step.
- 6Capture Chromatography (Protein A Affinity)First purification step.
- 7Viral Inactivation (Low-pH Hold)Mandatory ICH Q5A step.
- 8Ion Exchange Chromatography (IEX: CEX + AEX)Second polishing step.
- 9Hydrophobic Interaction Chromatography (HIC) - optionalOptional polishing for aggregate removal and bispecific mispair separation.
- 10Size Exclusion Chromatography (SEC) - PolishingAggregate and fragment removal by size.
- 11Ultrafiltration / Diafiltration (UF/DF - Concentration & Buffer Exchange)Concentration to target dose (1-50 mg/ml).
- 12Drug Substance Formulation & Final BulkAdjustment of final DS concentration and composition.
- 13Quality Control & Analytics + Stability StudiesProcess QC (endotoxin, sterility, pH, osmolality, SEC-HPLC, Raman identity).
S6 · Capture Chromatography (Protein A Affinity)7 products
- NaCl 5 M, stock solutionCT-77055Ionic strength adjustment for equilibration and wash buffers; used in ALL chromatography steps.
- Tris Buffer 1 M, pH 8.4CT-05500Equilibration buffer base: 25 mM Tris-HCl + 150 mM NaCl, pH 7.4 (from stock). Also neutralisation buffer base.; Neutralisation of acidic Protein A eluate: add ~1/10 volume - pH 5-6 -
- Citrate Buffer 100 mM, pH 3.0CT-62500Elution buffer base: 100 mM citrate pH 3.0 (from stock + WFI). Dual-use: Protein A elution AND viral inactivation.
- Glycine 100 mM, pH 3.0CT-69500Alternative Protein A elution buffer (glycine-based); preferred by some platform processes.
- WFI Quality WaterCT-991500All buffer preparation; Ph. Eur./USP.
- Sodium chloride solution 0,9 %P05-39500CT-39500 · coming soonSimple system flushing and equilibration wash.
- Ethanol 20 %CT-89500Column storage and sanitisation of the capture resin between cycles.
S7 · Viral Inactivation (Low-pH Hold)4 products
- Citrate Buffer 100 mM, pH 3.0CT-62500Viral inactivation acidification buffer (dilute to process concentration).
- Tris Buffer 1 M, pH 8.4CT-05500PH re-elevation after low-pH hold: add ~1/10 volume - pH 5-6.
- WFI Quality WaterCT-991500Buffer dilution; system flushing.
- Triton X-100 10 % solutionCT-01001Detergent-based viral inactivation (solvent/detergent method) as an alternative or adjunct to the low-pH hold.
S8 · Ion Exchange Chromatography (IEX: CEX + AEX)6 products
- Sodium acetate 100 mM, pH 4.5CT-76451CEX equilibration + wash buffer base: dilute to 25-50 mM NaAcetate pH 5.0. Also UF/DF and formulation buffer.
- NaCl 5 M, stock solutionCT-77055CEX gradient elution (0-500 mM NaCl); AEX wash and elution.
- Tris Buffer 1 M, pH 8.4CT-05500AEX equilibration buffer base (pH 7.0-8.0). Formulate with NaCl and WFI to running buffer.
- Phosphate Buffer 100 mMCT-18810AEX flow-through buffer base: 20 mM phosphate pH 7.0 + NaCl. Alternative to Tris for AEX.
- NaOH 1 M, stock solutionCT-55105CIP/SIP: column cleaning in place; column sanitisation; system regeneration between batches.
- WFI Quality WaterCT-991500Buffer preparation at process scale (100s of litres per run).
S9 · Hydrophobic Interaction Chromatography (HIC) - optional6 products
- Ammonium sulfate 1 MCT-67500HIC binding buffer base: dilute to 0.6-1.2 M (NH-)-SO- + phosphate/Tris for equilibration.
- Ammonium Sulphate 3 M stock solutionCT-68500Concentrated stock - dilute to 0.6-1.2 M for HIC binding; flexible high-salt base.
- Phosphate Buffer 100 mMCT-18810HIC running buffer base: 20-50 mM phosphate.
- Tris Buffer 1 M, pH 8.4CT-05500HIC equilibration / running buffer base (pH 7.0-8.0); combined with ammonium sulphate for high-salt binding.
- NaCl 5 M, stock solutionCT-77055HIC elution and strip buffer.
- WFI Quality WaterCT-991500Buffer dilution to process concentration.
S10 · Size Exclusion Chromatography (SEC) - Polishing6 products
- DPBS w/o Ca & MgCT-36500Ready-to-use PBS-based SEC running buffer (DPBS w/o Ca & Mg, ~pH 7.4); monomer / aggregate separation. Catalogue GMP.
- Histidine 100 mMCT-69510Alternative SEC running buffer; also primary UF/DF and formulation buffer. Histidine pH 5.5-6.5 is the most widely used mAb formulation buffer.
- Phosphate Buffer 100 mMCT-18810SEC buffer base.
- NaCl 5 M, stock solutionCT-77055SEC ionic strength adjustment.
- DPBS, (10x) w/o: Ca and MgP04-53500CT-53500 · coming soonSEC running-buffer prep: dilute 1:10 with WFI to DPBS 1x. 10x concentrate; shared with harvest (S5).
- WFI Quality WaterCT-991500Buffer preparation.
S11 · Ultrafiltration / Diafiltration (UF/DF - Concentration & Buffer Exchange)9 products
- Histidine 100 mMCT-69510Primary diafiltration buffer for mAb drug substance. Most common: 20-25 mM histidine pH 6.0 as working buffer.
- Sodium acetate 100 mM, pH 4.5CT-76451Acetate-based diafiltration buffer for IgG4/IgG2 (pH 4.8-5.5).
- Phosphate Buffer 100 mMCT-18810Phosphate-based diafiltration for IgG formulations pH 6.5-7.4.
- Sucrose 30 % stock solutionCT-00131Stability excipient; 5-10% sucrose in final formulation; cryoprotectant for drug substance.
- Trehalose 30 % stock solutionCT-00231Alternative cryoprotectant to sucrose; preferred for lyophilised mAbs and SC formulations; higher Tg.
- Polysorbate 20 (PS20) 1%CT-00211Aggregation prevention and surface adsorption protection. 0.01-0.05% in final formulation. Most common IV mAb surfactant.
- Polysorbate 80 (PS80) 1%CT-00311Alternative to PS20; preferred for SC and lyophilised formulations.
- DPBS w/o Ca & MgCT-36500Isotonic PBS-based diafiltration buffer; direct use without formulation.
- WFI Quality WaterCT-991500Diafiltration buffer preparation at production scale.
S12 · Drug Substance Formulation & Final Bulk13 products
- Histidine 100 mMCT-69510Final formulation buffer base. UNIFIED SKU across SEC (Step 10), UF/DF (Step 11) and DS formulation.
- Sucrose 30 % stock solutionCT-001315-10% sucrose in drug substance. Cryoprotectant + stabiliser. SHARED with UF/DF step.
- Trehalose 30 % stock solutionCT-00231Alternative cryoprotectant for lyophilised or SC formulations. SHARED with UF/DF step.
- Polysorbate 20 (PS20) 1%CT-00211Aggregation prevention in drug substance.
- Polysorbate 80 (PS80) 1%CT-00311PS80 alternative for SC/lyophilised.
- NaCl 5 M, stock solutionCT-77055Tonicity agent: isotonicity adjustment to 270-330 mOsm in final formulation. SHARED across all chromatography steps.
- Phosphate Buffer 100 mMCT-18810Phosphate-based formulation buffer.
- Sodium acetate 100 mM, pH 4.5CT-76451Acetate-based formulation buffer for IgG4/IgG2.
- DPBS w/o Ca & MgCT-36500PBS-based formulation for IV drug products. Ph. Eur./USP.
- WFI Quality WaterCT-991500Formulation buffer preparation; final concentration adjustment.
- EDTA 0.5 M, pH 8.0CT-10500Trace-metal chelation in the formulation buffer to limit metal-catalysed oxidation.
- L-Arginine 1 M, pH 7.0CT-69520Aggregation and viscosity control in high-concentration antibody formulation.
- Mannitol 10 % (w/v)CT-00401Bulking agent and stabiliser for lyophilised drug substance.
S13 · 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.
A handful of stocks, reused across the process
Rather than a separate finished buffer for every step, the 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 across the 12 process steps:
The GMP and regulatory foundation
Every product named here is manufactured by PAN-Celltech and offered at GMP grade. 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 are backed by filed FDA Drug Master Files that customers can reference in their own submissions. Only fixed product attributes (composition and, where defined, pH) are published as values; all further QC parameters are tested and released against a defined panel on every lot, with a Certificate of Analysis. Manufactured to GMP in an EU Annex 1 facility within an ISO 9001 quality system - audit-proven, not "GMP-certified".
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 monoclonal-antibody 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 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 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 paperFrequently asked questions
Does PAN-Biotech cover the whole monoclonal-antibody process?
Yes. PAN-Biotech supplies media, supplements, buffers and stock solutions for all twelve process steps of a typical mAb process - five upstream (cell-bank thaw, screening & selection, expansion & seed train, bioreactor production, harvest & clarification) and seven downstream (Protein A capture, low-pH viral inactivation, ion-exchange, HIC, SEC polishing, ultrafiltration/diafiltration, and drug-substance formulation), 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 are additionally backed by filed FDA Drug Master Files.
What is the stock-solution principle?
A small number of concentrated stock solutions recur across the workflow, so customers qualify fewer SKUs while keeping full flexibility to prepare their own working buffers. WFI quality water is used in all twelve production steps and DPBS in seven; the core chromatography stocks - NaCl 5 M, Tris-HCl 1 M, phosphate, acetate, histidine and citrate - each recur across several steps.
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 three major mAb platforms - CHO, HEK293 and hybridoma - with serum-free media, feeds and supplements; the downstream range is platform-independent and follows the standard Protein A capture, polishing and formulation train.