2D Bioprocessing Bags
Flat, pillow-style single-use bags for media preparation, buffer mixing and intermediate storage — 50 mL to 50 litres. GMP-certified film, gamma-sterilised, EU stock. No minimum order. 2–5 business days to DACH.
2D bioprocessing bags are flat, single-use containers for media preparation, buffer mixing, intermediate product hold and chromatography feed. SeamlessBio supplies them from EU stock in volumes from 50 mL to 50 litres — certified to USP <87>/<88> Class VI, manufactured on RENOLIT 9101 multilayer film, gamma-sterilised (ISO 11137, SAL 10⁻⁶), ISO Class 7 cleanroom. No minimum order. Full GMP documentation with every lot.
Optimised for Mixing
Flat geometry delivers maximum surface area on orbital shakers and rocking platforms — ideal for powder media reconstitution and buffer component dissolution.
RENOLIT 9101 Film
ULDPE/LLDPE fluid-contact layer, EVOH gas barrier, outer protective PE layer. Controlled extractables profile, USP <87>/<88> Class VI certified, ISO 10993 compliant.
50 mL to 50 Litres
Full volume range from bench-scale process development to pilot-scale production. Single-unit orders. Same documentation regardless of quantity.
Custom Port Configurations
Luer-lock, 3/8" male insert, AseptiQuick G, PCS/TPE tubing, end plug — configurable per SKU. Standard configurations in stock. Custom assemblies on request.
Where 2D bags fit in your process
2D bioprocessing bags — also called pillow bags or flat bags — are the standard single-use container for solution handling in biopharmaceutical manufacturing. Their flat geometry, combined with efficient port configurations, makes them particularly suitable for steps where mixing performance matters and where space is limited.
Unlike rigid vessels, 2D bags require no cleaning validation, no autoclave cycle and no cross-contamination control between batches. You open the bag, use it, and dispose of it. The regulatory documentation travels with the lot number — not with a reuse history.
SeamlessBio 2D bags are dimensioned for drop-in compatibility with the most commonly installed mixing systems in European bioprocessing facilities. Switching supplier does not require requalifying your downstream equipment.
Typical applications
- Powder media reconstitution (dry powder + WFI)
- Buffer preparation — PBS, phosphate buffers, wash buffers
- Intermediate product hold and short-term storage
- Chromatography column feed — loading, wash, elution fractions
- Harvest collection from small bioreactor runs
- Formulation component mixing and pooling
- Seed train media preparation for cell culture scale-up
- Viral vector upstream process support (AAV, lentiviral)
- mRNA lipid nanoparticle (LNP) buffer and reagent hold
- Process development at bench and kilo-lab scale
Material specification and certifications
Every SeamlessBio 2D bag is manufactured from RENOLIT 9101 multilayer film — the same controlled-extractables film platform used in regulated biopharmaceutical manufacturing in Europe and the US. The multilayer construction balances biocompatibility, mechanical integrity and gas barrier performance across the full volume range.
| Property | Specification |
|---|---|
| Film material | RENOLIT 9101 multilayer — ULDPE/LLDPE fluid-contact layer · EVOH gas barrier · tie layers · outer protective PE layer |
| Volume range | 50 mL – 50 litres (2D / pillow format) |
| Biocompatibility | USP <87> cytotoxicity; USP <88> Class VI biological reactivity; ISO 10993 compliant |
| Chemical resistance | USP <85> particulate matter; USP <661> plastics — compliant |
| Extractables | Controlled extractables profile; BPOG-aligned extractables data available on request |
| Sterilisation | Gamma irradiation, ISO 11137, SAL 10⁻⁶; double-bagged; ready-to-use from packaging |
| Manufacturing environment | ISO Class 7 cleanroom; 100% visual inspection; 100% leak testing; full lot traceability |
| BSE/TSE status | BSE/TSE-free declaration included with each lot |
| Regulatory readiness | EU GMP Annex 1 compatible; EMA ATMP Regulation (EC) No 1394/2007 documentation ready |
Port configurations — 2D bags
Port configuration determines how the bag integrates with your process — pumps, sensors, filters, filling needles and downstream connections. SeamlessBio stocks 2D bags in the most common standard configurations and sources custom assemblies on request, typically with a 3–5 week lead time for non-stock configurations.
Luer-Lock (male / female)
Standard connection for small-volume transfer, sampling and venting. Compatible with standard luer syringe and tubing sets.
3/8" Male Insert
High-flow port for process fluid transfer and pump connections. Common in chromatography feed and buffer transfer applications.
AseptiQuick G
Aseptic quick-connector for closed-system integration — sterile connection and disconnection without opening the fluid path.
PCS Tubing
Polycarbonate-based silicone tubing connection for peristaltic pump integration. Standard in media preparation and buffer transfer.
TPE Tubing
Thermoplastic elastomer tubing — chemical compatibility advantage for aggressive buffer formulations and organic solvent mixtures.
End Plug
Sealed port for unused connections. Maintains sterility of unused ports during storage and transport of pre-filled or staged bags.
Who calls us — and why
ATMP manufacturers (CAR-T, gene therapy, MSC)
A CAR-T team needs 12 bags for a Phase I batch. Supplier A from the US: 8 weeks lead time, pallet minimum. That's the call we get. Clinical-phase ATMP batches run in small volumes — SeamlessBio supplies single-unit quantities, ships from EU stock, delivers within the week.
Contract research organisations (CROs)
Three parallel client studies, three different bag volumes. A CRO covering 50 mL through 50 L from a single EU source — with per-lot CoA and project-specific documentation — eliminates multi-vendor coordination and procurement overhead.
Vaccine manufacturers at pilot scale
Pilot batches for clinical trials need the same documentation as commercial production. The only difference is volume. Supplier B from Sweden doesn't ship below one pallet. SeamlessBio does — with full lot traceability, biocompatibility docs, and delivery within the week.
Process development labs
Early-phase development runs at 200 mL, 500 mL, 2 L. Buying in bulk doesn't make sense. SeamlessBio supplies individual units — same GMP film, same certifications, no account setup, no minimum.
GMP documentation — standard with every lot
Regulatory submissions require material documentation. SeamlessBio provides this as standard — not on request, not at extra cost.
- Certificate of Analysis (CoA) — lot-specific
- USP <87> / USP <88> Class VI biocompatibility certification
- ISO 10993 compliance documentation
- USP <85> / USP <661> compliance statement
- Gamma irradiation certificate (ISO 11137, SAL 10⁻⁶)
- ISO Class 7 cleanroom manufacturing declaration
- BSE/TSE-free declaration
- Material Safety Data Sheet (MSDS/SDS)
- BPOG-aligned extractables data — on request
- Batch reservation documentation — on request
2D vs. 3D bags — choosing the right format
The bag format determines process compatibility. 2D and 3D bags are not interchangeable — geometry, mixing behaviour, and volume range are fundamentally different. The wrong format means process incompatibilities and validation rework.
| Criterion | 2D Bag (pillow bag) | 3D Bag (cube bag) |
|---|---|---|
| Volume range | 50 mL – 50 litres | 50 litres – 3,000 litres |
| Geometry | Flat / pillow — lays on flat surface or hangs | Cubic / freestanding — sits in stainless steel cage or support frame |
| Mixing | Excellent on orbital shakers and rocking platforms | Paddle or impeller-driven mixing via integrated port |
| Primary use | Media prep, buffer mixing, intermediate product hold, chromatography feed | Large-volume buffer hold, bulk transfer, upstream/downstream integration |
| Typical users | Clinical ATMP, CROs, process development, pilot vaccine batches | Commercial biopharma, large-scale vaccine production, biologics manufacturing |
| Footprint | Flat — hangs in use, stacks in storage | Requires cage/frame infrastructure |
| Film material | RENOLIT 9101 multilayer | RENOLIT 9101 multilayer (same certification basis) |
2D bag applications — by process step
2D bags are used across upstream and downstream bioprocessing wherever a flat, stackable, mixable container offers an advantage over rigid vessels. Key process steps where 2D bags are specified:
Media preparation
Dry powder medium + WFI in a 2D bag on a rocking platform. No autoclave, no clean-in-place cycle. Prepared batch documented, sealed, delivered to the bioreactor suite.
Buffer preparation and hold
PBS, equilibration buffers, wash and elution buffers — prepared in 2D bags and held at 2–8 °C until the column is ready. No carryover risk between batches.
Chromatography feed
Clarified harvest or intermediate product held in 2D bags as chromatography column feed. Gravity or pump-assisted transfer with direct port connection to column inlets.
Harvest collection
Small bioreactor runs — 2 L, 5 L, 10 L — harvested directly into 2D bags via peristaltic pump. Closed-system transfer, no open vessel exposure.
Viral vector upstream support
AAV, lentiviral, adenoviral vector production — 2D bags for media, transfection reagent prep and intermediate hold. Clinical-grade documentation for IND/CTA submissions.
mRNA / LNP process support
Buffer and excipient hold for lipid nanoparticle formulation processes. Controlled extractables profile critical for LNP stability — documented with BPOG-aligned extractables data.
Frequently asked questions
What is the minimum order quantity for 2D bioprocessing bags?
There is no minimum order at SeamlessBio. You can order a single bag or a full pallet — same pricing structure, same documentation. This is specifically designed for ATMP manufacturers, CROs and process development labs that cannot absorb pallet-level inventory commitments at clinical or early development scale.
What film is used in SeamlessBio 2D bags?
RENOLIT 9101 multilayer film — ULDPE/LLDPE fluid-contact layer, EVOH gas barrier, outer protective PE layer. The multilayer construction provides biocompatibility (USP <87>/<88> Class VI, ISO 10993), mechanical integrity across the volume range, and a controlled extractables profile suitable for BPOG-based extractables documentation.
Are 2D bags compatible with Sartorius, Cytiva or other mixing systems?
Compatibility depends on the specific bioreactor or mixing system and the bag holder geometry. Send us your equipment model — we confirm compatibility or recommend the correct bag geometry and port configuration before you order. Drop-in compatibility for the most commonly installed European systems is the standard target for our stock configurations.
How quickly are 2D bags delivered?
Standard delivery from EU stock: 2–4 business days to Germany and Austria; 3–5 business days to Switzerland (export documentation included). Express delivery is available on request. Contact us with your location, volume and required delivery date — we confirm availability from stock the same day.
Can I order custom port configurations?
Yes. Custom port combinations, non-standard tubing types and volumes outside the standard range are available. Standard configurations ship from EU stock. Custom assemblies have a lead time of 3–5 weeks and require a minimum quantity — contact us with your process requirements for a lead time and price indication.
What documentation is required for ATMP regulatory submissions?
For EMA ATMP submissions under Regulation (EC) No 1394/2007, starting material documentation for single-use containers typically includes: USP <88> Class VI certification, gamma irradiation certificate, extractables data, and BSE/TSE-free declaration. All of these are available from SeamlessBio as standard with each lot — no additional request required.
What is the difference between 2D and 3D bioprocessing bags?
2D bags are flat (pillow-style) — 50 mL to 50 L, optimised for mixing on rocking platforms or orbital shakers, typically used in media prep, buffer hold and chromatography feed. 3D bags are cubic — 50 L to 3,000 L, designed for large-volume storage and transfer in stainless-steel support frames. Both use the same RENOLIT 9101 film platform and carry equivalent GMP documentation.
Request a quote or order directly
Tell us your bag volume, port configuration and required documentation. We respond within 24 hours — with stock confirmation, pricing and delivery date.
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