GMP-Grade Cell Culture Media, Buffers & Water — Made in Germany
Ready-to-use GMP products manufactured to EU Annex 1 — the same formulations you use in research, now in GMP. Every PAN-Biotech product is available in GMP quality on request.
PAN-Biotech manufactures GMP-grade cell culture media, buffers, salt solutions and pharmaceutical-grade water for regulated clinical and commercial production. The GMP range is produced by PAN-Celltech, the group’s GMP arm, in a dedicated EU Annex 1 facility — with validated processes, controlled cleanroom conditions, full batch traceability and a complete documentation package. Every product is ready-to-use and shares the exact formulation of our research (RUO) catalogue, so you qualify once and scale from bench to GMP without changing supplier, formulation or documentation lineage.
GMP the way regulated manufacturing needs it
- EU Annex 1 manufacturing — produced under controlled, validated conditions for sterile products, by PAN-Celltech.
- Ready-to-use — directly usable in clinical and preclinical processes, no further adjustment.
- Ultra-low endotoxin & tested quality — high batch-to-batch consistency, released against defined specifications.
- The documentation is part of the product — Certificate of Analysis and Conformity per batch, full raw-material traceability, and DMF support where available.
- Stability data where you need it — ICH-compliant stability data / studies up to 60 months for selected products, and available on request for others.
- Regular media fill runs across packaging formats — routine aseptic process simulations that validate sterile filling from small vials to large single-use bags.
The same product, in RUO and GMP — off one shelf
Most suppliers make you choose: a research catalogue or a GMP manufacturer. PAN-Biotech offers many of the same formulations in matched RUO and GMP grades. The research grade carries a P- catalogue number; the identical GMP grade carries a CT- number — same recipe, same manufacturer, no re-qualification when you scale.
Every PAN-Biotech product is available in GMP quality on request.
The table shows what is on the GMP shelf today (a P- number for RUO, a CT- number for GMP);
anything not yet on the GMP shelf is produced to GMP as customised production by PAN-Celltech.
GMP-grade product range
21 GMP-grade products, all manufactured to EU Annex 1. Standard sizes shown; other sizes and formats (incl. bags) in the shop or on request. Source: Product Catalog 02.2026.
| Product | Details | Size | Article No. |
|---|---|---|---|
| CMRL-1066 | w/o L-Glutamine, w/o Phenol red, w: 2.2 g/L NaHCO₃ | 500 ml | CT-84600 |
| M199 w: EBSS | w: L-Glutamine, w: 2.2 g/L NaHCO₃ | 500 ml | CT-07050 |
| Panexin CD | Serum replacement with defined components | 100 ml | CT-93100 |
| Panexin basic | Serum replacement with defined components | 100 ml | CT-96900 |
| Trypsin 0.05 % / EDTA 0.02 % in DPBS | w/o Ca and Mg | 100 ml | CT-023100 |
| ISF-1 Medium for Hybridoma | w: stable Glutamine, w: Insulin human, w: 2.438 g/L NaHCO₃ | 1,000 ml | CT-995968 |
| HybridBoost | w: stable Glutamine, w: Insulin hum. rec., w/o Phenol red, w: 2.438 g/L NaHCO₃ | 500 ml | CT-995905 |
| HEPES Buffer 1 M | — | 100 ml | CT-01100 |
| L-Glutamine 200 mM | — | 100 ml | CT-80100 |
| Penicillin-Streptomycin | 10,000 U/ml Penicillin, 10 mg/ml Streptomycin | 100 ml | CT-07110 |
| Accutase Cell Detachment Solution | w: 0.5 mM EDTA, w: Phenol red | 100 ml | CT-21100 |
| DPBS | w/o Ca and Mg — backed by a filed FDA Type IV DMF | 500 ml | CT-36500 |
| DMEM | w: 4.5 g/L Glucose, w: L-Glutamine, w/o Sodium pyruvate, w: 3.7 g/L NaHCO₃ | 500 ml | CT-03550 |
| DMEM | w: 4.5 g/L Glucose, w/o L-Glutamine, w: Sodium pyruvate, w: 3.7 g/L NaHCO₃ | 500 ml | CT-03600 |
| DMEM | w: 4.5 g/L Glucose, w: stable Glutamine, w/o Sodium pyruvate, w: 3.7 g/L NaHCO₃ | 500 ml | CT-04500 |
| RPMI 1640 | w: stable Glutamine, w: 2.0 g/L NaHCO₃ | 500 ml | CT-18500 |
| RPMI 1640 | w: 2 mM L-Glutamine, w: 1 mM Sodium pyruvate, w: 4.5 g/L Glucose, w: 10 mM HEPES, w: 1.5 g/L NaHCO₃ | 500 ml | CT-18047 |
| RPMI 1640 | w: L-Glutamine, w: 2.0 g/L NaHCO₃ | 500 ml | CT-16500 |
| MEM Eagle | w: EBSS, w: L-Glutamine, w: 2.2 g/L NaHCO₃ | 500 ml | CT-08500 |
| MEM Eagle | w: EBSS, w: 2 mM L-Glutamine, w: 1 mM Sodium pyruvate, w: NEAA, w: 1.5 g/L NaHCO₃ | 500 ml | CT-08056 |
| MEM Eagle | w: EBSS, w/o L-Glutamine, w: 2.2 g/L NaHCO₃ | 500 ml | CT-08050 |
Coming soon in GMP
| Product | Details | Size | Article No. |
|---|---|---|---|
| PowerStem MSC 1 Kit | Serum- & xeno-free human MSC medium | 500 ml | CT-77355K |
| Cryopan II | Chemically defined, w: DMSO, protein-free | 100 ml | CT-94100 |
| Cryopan III | Chemically defined, w/o DMSO | 100 ml | CT-96100 |
GMP-compliant water – WFI Quality Water
Produced GMP-compliant to EP / USP WFI specifications, in bottles and single-use bags. (WFI Beyond is our premium water standard — offered separately for the most demanding applications.)
| Product | Details | Size | Article No. |
|---|---|---|---|
| WFI Quality Water | Per EP / USP specifications | 500 ml bottle | CT-991500 |
| WFI Quality Water | Per EP / USP specifications | 1 L bottle | CT-991000 |
| WFI Quality Water | Per EP / USP specifications | 10 L bag | CT-99010B |
| WFI Quality Water | Per EP / USP specifications | 20 L bag | CT-99020B |
| WFI Quality Water | Per EP / USP specifications | 200 L bag | CT-99200B |
| WFI Quality Water | Per EP / USP specifications | 500 L bag | CT-99500B |
The regulatory keystone — GMP DPBS with a filed FDA DMF
GMP DPBS (CT-36500) is backed by a filed FDA Type IV Drug Master File. Through a simple letter of authorisation you can reference PAN-Celltech’s confidential manufacturing and quality data directly in your own submission — without obtaining, holding or recreating it. For a buffer used across both upstream and downstream, that removes one of the heaviest items a lean QA function would otherwise build from scratch, and measurably de-risks your filing.
Why source your GMP materials from PAN-Biotech
- 38 years of bioprocess manufacturing — an independent German manufacturer since 1988; creator of the world’s first serum replacement (Panexin, 1992), now available in GMP grade.
- Scale and capacity — two facilities, ~1.8 million L/year combined, lot sizes from 1 L (RUO) / 2 L (GMP) up to 1,000 L, filling from small vials to 1,000 L single-use bags.
- Recognised quality — ISO 9001 and ISO 13485, FDA registration, EU Annex 1; GMP-compliant excipient manufacturing, confirmed in audits by leading NASDAQ/DAX-listed pharmaceutical and biotech companies.
- Named Top Contract Manufacturing Organization in Europe 2024 by Pharma Tech Outlook.
- 2,700 customers across 87 countries — serving biotech and pharma worldwide.
Frequently asked questions
What does “GMP grade” mean at PAN-Biotech?
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Our GMP-grade products are manufactured by PAN-Celltech in a dedicated EU Annex 1 facility under validated, controlled conditions, ready-to-use, with full batch traceability, a Certificate of Analysis and Conformity per batch, and DMF support where available. We describe them as GMP-compliant / EU Annex 1 — credibility rests on the documentation, audits and the DMF, not on a self-declared badge.
Are PAN-Biotech GMP products EU Annex 1?
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Yes. The GMP range is produced to EU GMP Annex 1 for sterile products, with GMP-compliant excipient manufacturing confirmed in audits by leading NASDAQ/DAX-listed pharmaceutical and biotech companies.
Do you offer a GMP version of every product?
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Yes. Every PAN-Biotech product is available in GMP quality on request. A range of 21 products is already on the GMP shelf — including DMEM, RPMI 1640, MEM Eagle, Medium 199, CMRL-1066, DPBS, HEPES, L-Glutamine, Trypsin/EDTA, Penicillin-Streptomycin, Accutase, HybridBoost, ISF-1, and Panexin CD and Panexin basic (the world’s first serum replacement, in GMP) — with PowerStem MSC1, Cryopan II and Cryopan III coming soon. Any other catalogue formulation is produced to GMP as customised production by PAN-Celltech.
Can I get the same medium or buffer in RUO and GMP?
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Yes — matched grades. The research grade carries a P- number and the identical GMP grade a CT- number, so you qualify once and scale from research to GMP without changing supplier, formulation or documentation lineage. For example, DPBS is P04-36500 (RUO) and CT-36500 (GMP).
Does PAN-Biotech have a DMF for DPBS?
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Yes. GMP DPBS (CT-36500) is backed by a filed FDA Type IV Drug Master File, which you can reference in your own submission through a letter of authorisation.
Can you manufacture a custom GMP product to my specification?
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Yes. PAN-Celltech (EU Annex 1) develops and manufactures custom media, buffers and reagents to your specification, from small batches up to 1,000 L, with the full documentation package.
Start a Custom & GMP Project Enquiry.
How do I order GMP-grade products?
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Browse and order the ready GMP range in the GMP-grade catalogue, or contact us for larger volumes and custom GMP production.