Product specification sheets
Telopeptide-removed Type I collagen for solutions, gels and coatings.
Sent. The specification follows by email.
Fibrous Type I collagen for sponges, scaffolds and structural matrices.
Sent. The specification follows by email.
Fibre membranes and mats produced by electrospinning, with porosity set to the application.
Sent. The specification follows by email.
Forms and options
One material stream, supplied in the forms a production line or a bench already handles. Every form shares one specification, so a format change is not a supplier change.
Tuned to one indication
Some applications need more than a raw material. Where a format does not exist yet, Alpstein’s development team works on the collagen side of the formulation with you, so the material meets the device halfway. Development runs follow the same line and ship with the same documentation as production supply.
Book a technical callHow Alpstein shortens the path
Gram scale material held to the same tolerances as clinical supply. A protocol written once stays valid.
Independent characterisation from Intertek, Oxford and Cambridge, ready to cite.
Questions about lot behaviour or a protocol that will not settle go to the manufacturing team.
Work that turns into a device or a therapy keeps the same material, supplier and documentation.
Most groups buy one large lot and ration it, because the next one may not behave the same way. Here a gram order is held to the specification clinical supply is held to, and the characterisation data is independent, so it can be cited rather than caveated. When the work becomes a product, the material, the supplier and the paperwork carry over.
Research and cell cultureFragment length is defined in process. Handling, degradation and viscosity stay where you validated them.
The same line and specification at every volume, so scale up does not reopen the verification plan.
ISO 13485:2016, ISO 22442 parts 1 to 3, TSE and BSE statements, cold chain and traceability to the herd.
Independent analysis rather than a certificate written by the seller.
A material that drifts between deliveries is expensive in ways that do not show up on the invoice: change control, repeated verification, stability re-run, a submission held back. One line and one specification at every volume make scale up a volume decision rather than a new qualification, and the supplier file is already written.
Devices and wound care


