ROUSSELOT B.V. of Son en Breugel at COMPAMED 2021 in Düsseldorf -- MEDICA - World Forum for Medicine
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ROUSSELOT B.V.

P.O. Box 47, 5691 NM Son en Breugel
Kanaaldijk Noord 20, 5691 NM Son en Breugel
Netherlands
Telephone +31 499 361-100
Fax +31 499 364-972
biomedical@rousselot.com

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Hall map

COMPAMED 2021 hall map (Hall 13): stand F70

Fairground map

COMPAMED 2021 fairground map: Hall 13

Our range of products

Product categories

  • 08  Raw materials, materials, adhesives
  • 08.09  Other raw materials, materials, adhesives

Our products

Product category: Other raw materials, materials, adhesives

X-Pure Gelatin

The X-Pure® range offers premium quality gelling and non-gelling (hydrolyzed) gelatins sourced from porcine skin (P) or bovine bone (B). Our gelatins and collagens mimic the extracellular matrix and are one of the most favorable biomaterials for tissue or stem cell bioengineering[1][2]. Our customizable range of gelatins, modified gelatins, and collagens minimizes the risk of prolonged or sustained inflammation caused by endotoxin exposure.

X-Pure gelatins offer premium-grade solutions, with tunable functionalities in addition to high-purity ≤10EU/g. X-Pure gelatins can be designed or customized to provide significant technical advantages for the development of biomedical applications. X-Pure gelatins are optimized for in-vivo or in-vitro research and clinical applications and produced under GMP conditions*

*IPEC & PQG Joint Good Manufacturing Practices Guide for Pharmaceutical Excipients.

Key features of X-Pure gelatin
Gelling and non-gelling properties 
Ultra-low endotoxin levels, suitable for sensitive applications
Supports cell viability and attachment
Supports cell growth and differentiation
Can be woven into a membrane

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Product category: Other raw materials, materials, adhesives

X-Pure GelMA

X-Pure® GelMA is the world’s first GMP ready[1] gelatin methacryloyl (GelMA or Gel-MOD) for preclinical and clinical applications in regenerative medicine.

X-Pure GelMA is a gold-standard biomaterial, ideal for 3D bioprinting and tissue engineering owing to its guaranteed ultra-low impurity levels and mechanical properties.
How X-Pure GelMA works
X-Pure GelMA creates tunable biological environments for culturing various cells at body temperature. It is functionalized via photo crosslinking[2]. This activates the methacrylamide side groups, causing them to polymerize, creating a viscoelastic gelatin network, making it one of the most versatile hydrogels available for 3D cell culture.

X-Pure GelMA can help reduce development time to clinic, for pharmaceutical, medical device and advanced therapy medicinal products, as well as cell and gene therapy products.
Key features of X-Pure GelMA  (or Gel-MOD)
Tunable physical and chemical properties
Crosslinking allows tunable physical environments suitable for a variety of cell types
Functional at body temperatures
Thermostable at 37oC
Ultra-low endotoxin levels, suitable for sensitive applications
Can support cell maintenance and growth
Customized GelMA upon request.

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Product category: Other raw materials, materials, adhesives

X-Pure GelDAT

X-Pure® GelDAT is the world’s first purified Gelatin Desaminotyrosine.

X-Pure GelDAT hydrogels are ideal for research and preclinical development in regenerative medicine, drug release and complex wound dressings due to their ability to crosslink with tissues and their purity. 

What X-Pure GelDAT offers
Consistency, Purity and Scalability:
X-Pure GelDAT has been developed to overcome the challenges researchers face when using gelatin tyramine (GelTYR). GelTYR production creates uncontrollable chemical side-reactions causing product loss, degradation and potential toxicological risks (1),(2). GelTYR is not suited to produce at scale in a controllable and consistent manner meaning synthesis and purification are almost impossible at industrial scale.

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Product category: Other raw materials, materials, adhesives

Rousselot® Quali-Pure™

Rousselot® Quali-Pure™ has been specifically designed for a variety of applications including embolization, wound healing, drug delivery, vaccines and hemostatics. Quali-Pure delivers biocompatibility, biodegradability, controlled endotoxin levels, and batch-to-batch consistency, and fully supports medical device compliance with ISO 22442 and the new EU Medical Device Regulation (MDR) standards.
The Quali-Pure range of high-quality gelatins offers device manufacturers an endotoxin-controlled gelatin, that delivers the optimal functional properties, as well as meeting the standards required to comply with the enhanced regulatory requirements. Quali-Pure gelatins come with full traceability, documentation and viral safety.
Quali-Pure is the latest addition to the Rousselot Biomedical portfolio that consists of X-Pure®biomedical gelatins, hydrolyzed gelatins and modified gelatins with endotoxin levels that are amongst the lowest in the world.
New EU MDR compliance 
Medical devise producers are facing increased safety requirements for biomaterials. From May 2024, all devices placed on the European market must conform with the new EU Medical Device Regulation (MDR). Regulation (EU) 2017/745 on Medical Devices (the MDR) has replaced the existing medical devices Directive (93/42/EEC) (MDD) and the active implantable medical devices Directive (90/385/EEC) (AIMDD). In addition, the ISO standard 22442 has been updated to bring it further in line with global requirements for medical devices.

Quali-Pure provides the supporting documentation for full compliance of medical devices with the new MDR requirements and with ISO 22442. “We design all of our biomedical gelatins with safety in mind. We aim to pro-actively support our customers towards regulatory compliance with full and documented traceability up to the farm (ISO 22442-2), validated viral inactivation (ISO 22442-3) and IPEC GMP compliance,” says Kathleen Jacobs, Regulatory Affairs Director at Rousselot Biomedical.

Quali-Pure gelatins are available from October 2021, and Quali-Pure hydrolyzed gelatins are expected to be added to the portfolio in the near future.

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Company news

Date

Topic

19 Oct 2021

Rousselot® Biomedical launches Quali-Pure™

Rousselot®, Darling Ingredients’ health brand and the global leader of collagen-based solutions launches Quali-Pure™, a range of gelatins for biomedical applications with controlled endotoxin levels. The latest addition to Rousselot Biomedical’s rapidly expanding portfolio, Quali-Pure has been specifically designed for a variety of applications including embolization, wound healing, drug delivery, vaccines and hemostatics. Quali-Pure delivers biocompatibility, biodegradability, controlled endotoxin levels, and batch-to-batch consistency, and fully supports medical device compliance with ISO 22442 and the new EU Medical Device Regulation (MDR) standards.

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About us

Company portrait

Pioneers of pharmaceutical grade gelatins and collagens that accelerate the translation of research to clinical practice

Rousselot Biomedical is a global leader in the production of purified, pharmaceutical grade, modified and non-modified gelatins and collagens for the biomedical industry. Our custom formulations of ultra-low endotoxin biomaterials (≤10 EU/g) can be modified and scaled to meet customer specifications for rapid translation from concept to clinic across a wide range of applications.