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4 years ago

Current Good Manufacturing Practice (GMP)

  • Text
  • Clinical
  • Produced
  • Recombinant
  • Collagenase
  • Serum
  • Proteins
  • Manufacturing
  • Cgmp
  • Tissue
  • Products
Overview of PELOBiotech's cGMP and as good as GMP products

Extracellular Matrix

Extracellular Matrix Proteins Cell attachment, 3D structures and microenvironment are items that moved into focus of cell culture scientists during the last decade. PELOBiotech offers a wide range of Extracellular matrix (ECM) structures to support your cell cultivation. ECM has important signaling functions and is highly specific to each organ. Together with our partner Akron Biotech we offer research grade products that are more cost-effective for basic research but are identical to their GMP grade counterparts, thus eliminating the need for further optimization or repeating any experiments. The only difference between research grade and GMP grade is the level of documentation required to meet GMP regulations. At the moment we can offer fibronectin as GMP-product ready for use. For other ECM-proteins we will setup the GMP-production for our customers. A new organospecific Matrix will be available soon: TissueSpec Extracellular Matrices will offer your cells physiological features – mechanical and biochemical properties – found in natural organs, for clinical applications coming soon. Recombinant Proteins Recombinant proteins offered by our partner Akron Biotech are produced under GMP conditions and called premium grade. The main advantage for you is that you can easily cross from pre-clinical research and clinical research using proteins which will not differ in quality and performance. You don´t need to test again - just relax, switch and go on with your project. At PELOBiotech you find a product range of human cGMP Proteins, GMP-like Proteins, animal-free Proteins and classical research grade Proteins. All these proteins can be produced under GMP and this allows you to continue working with the identical product. Already available human GMP proteins are: Ask us to upgrade your cGMP-like protein to a cGMP one. • EPO • G-CSF • GM-CSF • bFG • IL-2 • VEGF • INFα2a • INFα2b • INFα1a • IGF-1 LR3 • EGF Just call us to receive our Product List Recombinant Proteins. You will find different sections of recombinant proteins which are sorted by product quality. Industry-leading products manufactured under strictly controlled, validated and verified quality systems. HOW TO ORDER: CALL: +49 (0)89 517 286 59-0 10

For Order Information just scan the QR-Code with your smartphone. Human Serum & Platelet Lysate To accompany your research from bench to bedside we offer premium grade products as well as Good Manufacturing Practice (GMP) products. Premium grade is produced under GMP conditions without being GMP. This guarantees that you can easily switch from basic research to pre-clinical research without testing the used products again. Human AB-Serum, A-Serum and human platelet lysate (hPL) can be used as a source of growth factors to replace bovine serum in cell culture medium. E.g. growth kinetics for primary cells maintained in 5% hPL-containing medium were found to be comparable to that of medium supplemented with 10% FBS. Replacing bovine serum with hPL allows for expansion and clinical grade production of functional mesenchymal stromal cells by removing the risk of xenogenic immune reactions and transmission of bovine prion and viral pathogens. It is validated with adiposal derived mesenchymal stem cells and it can be used with other cell types such as fibroblasts, keratinocytes and adipocytes. The GMP production leads to use it in culturing media for any therapeutic product as an attractive alternative to normal animal sera. We offer different qualities so you can easy chose the best hPL for your application: UltraGRO in R&D as well as in cGMP (Heparin has to be added) UltraGRO Advanced in R&D as well as in cGMP (no Heparin to add) UltraGRO Advanced GI (virus inactivated) in R&D as well as in cGMP UltraGRO PURE in R&D as well as in cGMP (no Heparin to add) UltraGRO PURE GI (virus inactivated) in R&D as well as in cGMP Main applications are ex-vivo expansion of MSCs, human Fibroblasts and many other cells. Human A & AB Serum Human AB serum is used in many applications e.g. tissue engineering, transplantation of T- cells, in cell therapy of CAR-T cells. The advantage for many applications of AB serum is the lack of antibodies against the A and B blood-type antigens. Human serum AB is commonly used when there is the need to minimize immunoreactivity. Human A serum can also been used for most of the above mentioned application if immunoreactivity is not a major issue. The advantage of human A serum is the broader availibility in comparison to AB serum. We can offer both products in R&D and cGMP quality. www.pelobiotech.com HOW TO ORDER: CALL +49 (0)89 517 286 59-0 9

Clinical Produced Recombinant Collagenase Serum Proteins Manufacturing Cgmp Tissue Products



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