Sammelreservierung
Reserve your validated FBS or human serum lot for your entire project — no prepayment, no risk. SeamlessBio holds the lot in EU storage and you call off quantities when you need them. Essential for IVD calibrator programmes, ATMP development and any process where lot consistency is critical.
Why Lot Reservation Is Non-Negotiable
The Problem: Forced Lot Changes
Once a serum lot is incorporated into a validated process — whether an IVD calibrator, ATMP manufacturing or an established cell culture protocol — a dependency on that specific lot is created. When the lot runs out and a new lot must be introduced, the following steps are mandatory:
- Comparability study (old lot vs. new lot)
- Change control documentation
- For IVD: potential notification to notified body (IVDR)
- For ATMP: update to manufacturing documentation
- Production downtime during requalification
The total cost of a forced lot change at a mid-size IVD manufacturer typically ranges from EUR 20,000 to EUR 50,000 — plus production downtime.
The Solution: Reserve at First Qualification
Reserve your full lot requirement for the project or product lifecycle at first qualification. SeamlessBio holds the validated lot — you call off quantities when needed, without requalification, without lot changes, without change control.
Typical Use Cases
- IVD Calibrators & Controls — Reserve for full product lifecycle (typically 3–5 years). Reserve once, call off continuously.
- ATMP & Cell Therapy — GMP processes require lot consistency across the entire clinical development phase. A lot change in Phase II/III is a regulatory risk.
- CRO / Long-term Studies — Studies running 12–36 months require the same serum lot throughout. Lot consistency is a GLP requirement.
- Manufacturing Campaigns — Production batch comparability depends on consistent serum lot. Unvalidated lot changes are a GMP deficiency.
How Batch Reservation Works
Identify Your Lot
Choose your product and test the lot in your system. SeamlessBio provides free test volumes for pre-qualification — no commitment required at this stage.
Calculate Your Requirement
Estimate your total need for the project period. Err slightly on the high side — unused quantities are renegotiated at expiry, not forfeited.
Reservation Agreement
No prepayment. SeamlessBio issues a reservation confirmation with lot number, reserved quantity and call-off period. One email — no contract complexity.
Storage at SeamlessBio
The lot is held at our Passau, Germany facility in validated cold storage (−20°C or −80°C). Full documentation per lot available at any time.
Call-Off as Needed
Call off your required quantity at any time — in your preferred pack sizes, with CoA and full lot documentation per delivery. Cold-chain delivery across Germany and the EU.
Available Products for Reservation
Fötales Rinderserum (FBS)
All 9 grades. Especially important for hybridoma, ATMP and long-term studies requiring lot consistency.
Menschliches Serum und Plasma
All 10 variants. Lot reservation essential for IVD calibrator programmes and ATMP manufacturing.
BSA, HSA & rHSA
Albumin lots for IVD calibrator stabilisation and cell therapy formulations.
Tierische Seren
NCS, Calf Serum and 16 species. Lot consistency for vaccine production and long-term studies.
Frequently Asked Questions
What does batch reservation cost?
The reservation is free — no prepayment, no reservation fee. Payment only on individual call-off deliveries at the agreed price. No penalty for calling off less than reserved.
How long can a lot be reserved?
Up to 12 months as standard. For long-running IVD product programmes or multi-year ATMP development projects, longer periods can be agreed individually.
What happens if I call off less than reserved?
No automatic forfeiture, no penalty fees. Unused quantities are renegotiated at expiry — extended, reduced or returned. We discuss the situation together.
Which products are available for reservation?
All SeamlessBio sera and biological materials: FBS (all grades), Human Serum (all variants), NCS, Calf Serum, all Animal Sera, BSA, HSA and rHSA. Contact us with your specific product and volume.
Reserve Your Lot — Send Enquiry
Tell us your product, preferred lot (if known), total quantity and project timeline. We respond within 48 hours.
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