Resources
Datasheets, technical papers, application notes, explainer videos and more.
Datasheets, technical papers, application notes, explainer videos and more.
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Praesto® Agarose Resins
Praesto Protein A Resins
Praesto Ion Exchange Resins
Praesto Pure
Praesto Epoxy
Praesto CNBr
Praesto NHS
Pre-packed Columns
Praesto 'Jetted' 35 µm High Resolution Ion Exchange Resins
Praesto 'Jetted' A50 Jetted resins
Laboratory-scale columns for performance screening
Antibody Purification Ligand Selection Table
Chromalite® Styrene/DVB Resins
Chromalite® Methacrylic Resins
PuroSorb™ polymeric adsorbents (PAD)
Lifetech™ Enzyme Immobilization Resins
Lifetech™ Ready-to-use Immobilized Enzymes
Monoclonal Antibody Purification
Studying the lifetime of Praesto Jetted A50 & Praesto AP+
Evaluation of recent Protein A stationary phase innovations for capture of biotherapeutics
Resin Sourcing for Biopharmaceutical Manufacturers
Manufactured by Jetting - The Future in Protein A Affinity Matrix Design
Are All Protein A Resins the Same
A Strategy for Cost-Effective Capture Using Agarose-Based Protein A Resins
Integration of XCell™ ATF Perfusion with Single Column Capture
Enzyme Immobilization
Cannabinoid Purification
Praesto Protein A and Ion Exchange Resin Packing Instructions
LIFETECH™ BIOCATALYSIS SERVICES
We offer a variety of services to aid you in improving your process. Contact us for expert,hands-on support with:
• Immobilization screening
• Immobilized enzyme sampling
• Analytical method development
• Immobilization scale-up
• Immobilization optimization
• Site visits for hands-on technical support
• Report writing
Click the orange ‘Contact Us’ button to talk to our Technical Support team.
CUSTOM RESIN-DESIGN PROJECTS
We have one of the widest portfolios of 'off-the-shelf' chromatography and biocatalysis resins in the world, available in a wide range of base matrices and functionalities. As such, we usually have the ideal resin for you.
However, for certain applications we are able to utilize Purolite-patented technology to offer custom-designed resins, tailored to your process. Contact our Technical Support team to learn more.
Click the orange ‘Contact Us’ button to talk to our Technical Support team.
BIOPROCESS COLUMN PACKING SUPPORT
Our dedicated bioprocessing column packing suite is equipped with best-in-class pilot and process-scale equipment commonly used for mAb purification. Here, we provide expert, hands-on training to increase your packing success rates at both pilot and process scales, as well as demonstrate scale-up performance of our Praesto® agarose-based mAb purification resins.
Whether you use manual or automated packing methods, talk to us today for guidance on topics such as packing/unpacking, column priming, pressure flow testing, efficiency testing and slurry/buffer preparation.
Click the orange ‘Contact Us’ button to talk to our Technical Support team.
Bioprocess Industries Programme Modular Training
Food and Drug Administration & EC ResAP (2004)3
The Purolite Romanian manufacturing facilitiy is US-FDA inspected for the production and distribution of APIs. Products used in food and beverage consumption comply with ResAP (2004)3 and/or FDA 173.25 and 173.65 regulations.
Establishment Inspection Report
Establishment Registration Renewal Certificate
Current Good Manufacturing Practice Certificate
Resolution ResAP (2004)3
FDA 173.25 Ion Exchange Resins
FDA 173.65 Adsorbents
Halal Certification
Purolite produces Halal products under the supervision of several respected Islamic Councils.
China | Romania | United States
The Indonesian Council of Ulama, has also declared the China manufacturing plant to be Halal certified. Download the MUI certification for the China facility.
China
Kosher Certification
Purolite manufactures products in compliance with kosher production and packaging rules. Visit Kosher Certification and search Purolite for a complete list of our kosher-certified products
Food & Drug Administration Documentation - Chromalite®
TSE/BSE
All manufacturing and packaging equipment, raw materials and processing aids used in producing the below Purolite enzyme carriers comply with Annex IIIa of Directive 2000/13/EC, amended by Directive 2007/68/EC and are free from Transmissible Animal Spongiform Encephalopathy (TSE/BSE) or Genetically Modified Organisms(GMO) or Allergens.
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Regulatory Information
Regulatory expertise throughout the product life-cycle is essential to identify regulatory options for product development, optimize ‘speed to market’ and produce a product that meets customer needs.
View our Regulatory Information brochure for information on existing regulatory approvals.
Classification, Labeling and Packaging (CLP) Regulation
Purolite complies with the EU regulation (EC) N0 1272/2008 CLP, to ensure that hazardous mixtures are clearly communicated through product classification, labeling and packaging.
ISO Certification
Purolite facilities are certified by the International Organization for Standardization (ISO), guaranteeing our products are manufactured to meet consistent high quality standards. Download the ISO 9001:2008 or ISO 9001:2015 certification for each manufacturing plant.
Brazil | China | Romania | United Kingdom | United StatesDownload ISO 14001:2015 certification for Purolite's laboratory in Wales.
United KingdomOHSAS 18001 Certification
Purolite Ltd, Llantrisant, United Kingdom and Purolite S.R.L. Victoria, Romania are certified to operate in compliance with the requirements of BS OHSAS 18001:2007.
Download PDF
REACH Compliance
Purolite is fully aware and committed to REACH, and confirms its compliance with this European Regulation.
Read our Statement of REACH Compliance
RoHS Certification
Purolite certifies that our products are in compliance with the EU Directive 2015/863 on the Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS 2).
View Compliance Statement