Frequently asked questions
Albumedix supports you all the way
Below you will find answers to some of the questions that we are frequently asked about in relation to our recombinant human albumin product protfolio (Recombumin®) and technologies (Veltis®). If you have any other questions, our experts will be happy to answer them for you.
1. What is Recombumin?
Recombumin is Albumedix’ recombinant human albumin product portfolio. Albumedix has more than 30 years of experience working with albumin and this is the sole focus of our business – we are now proud to be recognized as world leaders in recombinant human albumin.
2. How can I purchase Recombumin?
Please contact us for further product information or inquiries regarding placing an order of Recombumin.
3. How is Recombumin produced?
Recombumin is manufactured at Albumedix manufacturing site in Nottingham, UK. Our recombinant human albumin is manufactured from our proprietary Saccharomyces yeast strains, at ICH Q7 cGMP standards. As such Recombumin is the highest quality animal origin-free rAlb product commercially available.
4. For which application areas can Recombumin be used?
Albumedix recombinant human albumin, Recombumin is a very versatile stabilizer already used across multiple application areas (pipeline). Recombumin can address a variety of formulation challenges for peptides & proteins, vaccines, cell therapies or medical device coating.
5. Is Recombumin used in any marketed products?
Yes – Albumedix’ recombinant human albumin, Recombumin is already used in two marketed vaccine products; Merck & Co’s MMR®-II and Proquad® childhood vaccines (pipeline). Since Recombumin was introduced in the MMR®-II vaccine in 2006 more than 70 million doses have been administered in children worldwide. In addition to these, Recombumin is used in several medical devices.
1. What is Veltis?
Veltis is a clinically-proven technology (pipeline) based on native and engineered albumins that allows drug developers to control peptide or protein dose size and frequency to achieve stricter patient adherence (compliance) for improved therapeutic impact. Drug candidates are either genetically fused or chemically conjugated to the albumin variants. Veltis® can also be used for small molecules through chemical conjugation of the engineered albumin to the drug candidate.
2. How can I get access to Veltis?
Please contact us to discuss the needs of your drug candidate, and how, in partnership with Albumedix, you can genetically fuse or chemically conjugate your drug to improve dosing.
3. Can I freeze samples of Veltis based albumin?
There should be no need to freeze the albumin provided by Albumedix before use in conjugation work if samples are maintained in well-stoppered and clean containers to exclude oxygen.
4. What technical and application data can Albumedix share on Veltis?
We can share data on the fundamental properties of Veltis based albumin, formulation, stability under various conditions and treatments, and recommendations for how to conjugate drugs to the free thiol of Veltis recombinant albumins. Further to this, we can also guide on the best way of developing a genetic fusion of your drug with the Veltis platform.
5. How much endotoxin does Veltis contain?
Albumedix uses Saccharomyces cerevisiae as an expression host. As this does not produce endotoxins, the Veltis manufacturing process can deliver material with very low endotoxin levels. Please contact us if you have any questions regarding specific levels of endotoxin for your application.
6. According to which standards is Veltis-based albumin produced?
Currently samples are produced to levels sufficient for in vitro testing and in vivo efficacy studies. Through its own facilities, or at those of its partners, Albumedix can provide cGMP materials for clinical studies and for commercial production.
7. How can Albumedix support the registration of my product?
Albumedix can support the registration of your product by giving you access to our highly experienced regulatory support team. Please contact us for further information.