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 Novozymes & ProMetic Strategic Alliance
  Last year (February 2nd 2010) Novozymes and ProMetic announced that they had entered into a strategic alliance regarding proprietary albumin purification technology based upon a synthetic-ligand affinity adsorbent developed by ProMetic. This purification technology has been designed for the rapid and cost-effective development of Novozymes' AlbufuseŽ albumin-fusion molecules. Under the terms of the ProMetic-Novozymes alliance, both companies are jointly promoting the use of a new synthetic-ligand affinity adsorbent, marketed under the trade-name AlbuPureŽ, as a platform approach for the purification of albumin and albumin-fusion proteins. ProMetic is the exclusive manufacturer and supplier of AlbuPureŽ. Both parties retain ownership of their respective technologies. AlbuPureŽ was derived from ProMetic's Mimetic Ligand™ technology and targeted at the capture and purification of albumin-fusion proteins produced in yeast. AlbuPureŽ binds specifically to the albumin portion of the molecule and so can be used for the purification of any AlbufuseŽ albumin-fusion protein. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
AlbufuseŽ Expression Technology Novozymes has developed AlbufuseŽ expression technology to enable the genetic fusion of a client's target protein to albumin at the molecular level. The resultant moiety is secreted as a contiguous peptide linked via a peptide bond. AlbufuseŽ technology represents a simple but flexible platform for the production of proteins with extended circulatory half-life, and with new AlbufuseŽFlex the possibility of modulating half-life and eliminating lengthy and costly post-production chemical processing such as PEGylation. Novozymes have extended their capabilities in protein expression by engineering Saccharomyces cerevisiae to produce albumin-fusion proteins in an animal component free system.
- Increased half-life of the active molecule, resulting in:
- Less frequent administration
- Increased bioavailability
- Reduced dose rates
- Reduced side effects
- Possible reduction in immunogenicity
- No requirement for post-production chemical derivatization
- Single source license for production and half-life extension technologies
- Competitive production costs.
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AlbuPureŽ Affinity Capture Adsorbent Albumin has a vast array of applications within the biopharmaceutical industry including as a fusion partner to extend the half-life of a protein drug whilst maintaining it's activity. In order to support the rise in the production of a wide range of recombinant albumin-fusion proteins, an affinity matrix has been developed by PBL that is highly stable, robust, non-toxic and provides high binding capacity, recovery and purity - AlbuPureŽ. AlbuPureŽ,developed in collaboration with Novozymes and manufactured exclusively by PBL, is produced in a controlled environment to ISO 9001 quality standard and is designed for use in cGMP manufacturing of biological molecules. AlbuPureŽ Key Benefits: - Proven Mimetic Ligand™ technology
- Excellent flow properties
- High dynamic binding capacities
- Robust & long life adsorbent
- Sanitizable using sodium hydroxide
- Colorless ligand
- Rugged & easy to pack - PuraBeadŽ 6HF base matrix
- Manufactured to ISO 9001 accredited standard
- Single batches produced of up to 275 liters
- Supported with a comprehensive regulatory support file
 AlbuPureŽ Special Introductory Offer:
For a limited period of time PBL are offering evaluation volumes of AlbuPureŽ at a special introductory price with a discount of up to 50% off the regular purchase price. To purchase AlbuPureŽ at this discounted price please do not hesitate to contact us at sales@prometicbiosciences.comAlternatively visit the PBL website www.prometicbiosciences.com
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 Lunch & Learn Seminar The Lunch & Learn Seminar provides an informal environment to meet representatives from both Novozymes and PBL to discuss topics about the complete production and purification package available for albumin-fusion proteins. The Lunch & Learn Seminar is a free event held in a location close to you, takes approximately one hour and includes; a lunch, presentations on selected topics and an open forum to ask questions. So contact us today to book a Lunch & Learn Seminar in your area. Lunch & Learn Overview: - Organizers: Novozymes & PBL
- Topics: (1) AlbufuseŽ expression technology (2) AlbuPureŽ affinity capture adsorbent
- Duration: Approximately one hour
- Location: At a location near you
- Contact: Steve Profit (PBL Representative) techsupport@prometicbiosciences.com
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 | | Dr. Mehryar Behizad - PBL Head of Quality & Regulatory Affairs |
PBL Quality & Regulatory Affairs Team Regardless of whether you use one of PBL's off-the-shelf products or have opted to emulate the success of AlbuPureŽ and use one of our custom designed affinity chromatography adsorbents developed specifically for your bio-processing application, PBL Quality and Regulatory Affairs Team is there to support you.
All our adsorbents are made for use in GMP processes. We have adopted a QbD (Quality by Design) approach to the design, development and manufacture of all our adsorbents governed by a rigorous quality system using the ISO 9001 quality management standard to which we have been accredited since 1996; being one of the first such accreditations in the biotechnology industry worldwide. PBL has very experienced teams both in Quality Assurance and Quality Control and well established practices in the gathering and provision of regulatory support data for all our products. Typically this data includes identity, batch reproducibility, stability, safety data and extractables and methods of analysis which can be presented either in the form of a Regulatory Support File (RSF) or even in the form of a FDA Type II Drug Master File if required. That said, our customers typically opt for the former option and include our RSF's in the CMC part of regulatory filings for their own products.To date PBL adsorbents form key parts of manufacturing processes for twelve regulated biopharmaceutical and biomedical products. These continue to be supported with updates to the RSF as and when new information becomes available. We are also always more than happy to directly support you in any meetings or direct interactions you may have with Regulatory Authorities which relate to or involve the use of our products.If you would like to contact Mehryar with regards to any information on Quality and Regulatory Affairs at PBL please use the details below:
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BioProcess International™ - Conference and Exhibition 