PL BioScience GmbH
Booth number: 26 - 04
www.pl-bioscience.com
About us
Located in Aachen in Germany, PL BioScience GmbH is a life science company specializing in the production and development of Human Platelet Lysate (HPL), offering a complete portfolio of HPL products tailored for various use cases; from standard laboratory research to GMP compliant cell therapies.
PL BioScience was founded in 2015 as an RWTH Aachen University spin-off. Since then, they have been exploring the broad potential of human platelets with a mission is to enhance advances in cellular research and therapy with one forward-looking Technology: ELAREM™. The high growth factor content of HPL combined with its animal-free origin not only supports optimal cell growth, but also enables it’s use in various applications.
From academic research, pre-clinical research, to cellular therapy, the high quality GMP compliant standards of ELAREM™ ensures seamless transitions of regenerative medicine breakthroughs – from the lab to patients in need.
Address
Auf der Hüls 184-186
52068 Aachen
Germany
E-mail: info@pl-bioscience.com
Phone: +49 241 95719-100
Internet: www.pl-bioscience.com
Contact person:
Products & Services
ELAREM™ Human Platelet Lysate – A superior technology to produce safe & efficient cell culture supplements
As a company focusing on Human Platelet Lysate (HPL) development and supply for many years, we have a rich knowledge base. Since 2015, we have been exploiting the broad potential of human platelets – the basis of our growth-promoting cell culture media. Take an inside look into the technology behind the name ELAREM™.
ELAREM™ Ultimate-FD PLUS - GMP Grade
ELAREM™ Ultimate-FD PLUS is a gamma irradiated, fibrinogen-depleted and anticoagulant-free Human Platelet Lysate of EU origin. As a xeno-free cell culture supplement, the product supports the efficient and safe in vitro expansion of primary cells and cell lines. The product is especially suited to cell manufacturing applications requiring proven viral reduction, e.g. for potential use in clinical trials.
While all ELAREM™ Human Platelet Lysates are manufactured from screened platelet units, ELAREM™ Ultimate-FD PLUS ensures additional safety. Thus, the product undergoes gamma irradiation at a dose range of 38-55 kGy as a final manufacturing step. By conducting a viral clearance study, we demonstrated viral reduction for the tested viruses while preserving cell culture performance.
ELAREM™ Ultimate-FD PLUS enables enhanced traceability throughout the entire product lifecycle. The Human Platelet Lysate is manufactured from platelet units obtained from healthy donors at licensed blood centres in the EU. By ensuring an EU-based raw material supply chain, we provide a traceability over 30 years back to blood component. Each batch is produced from large pools of platelet units. Consequently, this ensures batch-to-batch consistency and enables reproducible conditions.
ELAREM™ Ultimate-FD PLUS is manufactured, tested and released in compliance with the relevant GMP guidelines. The manufacturing process for the product is patented.
Certificate of Analysis (CoA) and Safety Data Sheet (SDS) are available upon request.
Our Quality Management System is ISO 9001:2015 certified.
ELAREM™ Ultimate-FDi - GMP Grade
ELAREM™ Ultimate-FDi is a virus-inactivated and fibrinogen-depleted Human Platelet Lysate of US origin. The GMP conform cell culture supplement is suited to clinical trial and therapeutic cell manufacturing needs.
ELAREM™ Ultimate-FDi is manufactured, tested and released in compliance with the relevant GMP guidelines. The final product is gamma-irradiated in order to comply with the highest safety guidelines for clinical applications. Virus panel testing is performed according to ICH and EMA guidelines (ICH Q5A (R1) and CPMP/BWP/268/95).
Due to the fibrinogen-depletion process, ELAREM™ Ultimate-FDidoes not require anticoagulant addition. Traces of a xeno-free anticoagulant may be present in the Human Platelet Lysate.
Each batch of ELAREM™ Ultimate-FDi is produced from large pools of platelet units to ensure batch-to-batch consistency and enable reproducible conditions.
ELAREM™ Ultimate-FDi is manufactured from platelet units obtained from healthy blood donors at licensed blood centres in the US.
Certificate of Analysis (CoA) and Safety Data Sheet (SDS) are available upon request.
ELAREM™ Perform-FD PLUS - Research and GMP Grade
ELAREM™ Perform-FD PLUS is a fibrinogen-depleted and anticoagulant-free Human Platelet Lysate of EU origin. As a xeno-free and easy-to-use cell culture supplement, ELAREM™ Perform-FD PLUS supports the efficient and safe in vitro expansion of various primary cells and cell lines. ELAREM™ Perform-FD PLUS GMP Grade is suited to cell culture applications that are subject to regulatory requirements but do not require viral inactivation steps, while ELAREM™ Perform-FD PLUS Research Grade supports the efficient and safe in vitro expansion of various primary cells and cell lines.
Due to a unique fibrinogen-depletion technique, ELAREM™ Perform-FD PLUS is a clot-free and anticoagulant-free Human Platelet Lysate. As a result, the product neither requires the addition of anticoagulants in cell culture nor during manufacturing. That makes ELAREM™ Perform-FD PLUS a ready-to-use Human Platelet Lysate that is widely applicable, since the absence of anticoagulants offers even more convenient cell growth conditions.
ELAREM™ Perform-FD PLUS is manufactured under an ISO 9001:2015 certified Quality Management System. Each batch is produced from large pools of platelet units. That ensures batch-to-batch consistency and enables reproducible conditions. ELAREM™ Perform-FD PLUS is manufactured from platelet units obtained from healthy blood donors at licensed blood centres in the EU.
ELAREM™ Perform - Research and GMP Grade
ELAREM™ Perform is a Human Platelet Lysate of EU origin supporting in vitro expansion of various primary cells and cell lines. The xeno-free cell culture supplement meets the requirements of academic and industrial cell expansion: The safe and performance-increasing cell growth promoter ensures efficient lab processes and a xeno-free cell environment. As a result, ELAREM™ Perform GMP Grade assures an easy transition of research results into clinical applications.
ELAREM™ Perform GMP Grade is manufactured under an ISO 9001:2015 certified Quality Management System and GMP conform conditions. Furthermore, the production process is performed within a closed system using sterile connections and high quality raw materials. As a result, ELAREM™ Perform GMP Grade is suited for usage in GMP compliant cell culture SOPs.
Each batch of ELAREM™ Perform GMP Grade is produced from large pools of platelet units to ensure batch-to-batch consistency. This enables reproducible conditions. Moreover, ELAREM™ Perform GMP Grade is manufactured from platelet units obtained from healthy blood donors at licensed blood centres in the EU.
Certificate of Analysis (CoA) and Safety Data Sheet (SDS) are available upon request.
Please note: Don’t miss to use an anticoagulant with this product. The addition of anticoagulants is necessary to avoid clotting caused by fibrinogen.
ELAREM™ Perform-FD - Research and GMP Grade
ELAREM™ Perform-FD is a fibrinogen-depleted human Platelet Lysate of US origin. As a cell culture supplement, ELAREM™ Perform-FD supports in vitro expansion of various primary cells and cell lines.
Due to the fibrinogen-depletion process, ELAREM™ Perform-FD GMP Grade does not require anticoagulant addition. As a result, application workflows are simplified. Traces of a xeno-free anticoagulant may be present in the Human Platelet Lysate.
Each batch of ELAREM™ Perform-FD GMP Grade is produced from large pools of platelet units to ensure batch-to batch consistency and enable reproducible conditions.
ELAREM™ Perform-FD GMP Grade is manufactured under GMP conform conditions using high quality raw materials. Furthermore, the production process is performed within a closed system using sterile connections. ELAREM™ Perform-FD is manufactured from platelet units obtained from healthy blood donors at licensed blood centres in the US.
Certificate of Analysis (CoA) and Safety Data Sheet (SDS) are available upon request.