Well Characterized Biologicals, IBC
Meet up with Albumedix at the 2017 Well Characterized Biologicals, IBC
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 Veltis® technology platform. If you have any other questions, our experts will be happy to answer them for you.
What is Veltis®?
Veltis® is a clinically-proven technology 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.
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.
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.
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.
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.
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.
Which type of Drug Master File (DMF) describes Veltis® based albumins? Can I have access to this information?
While a master file has not yet been submitted to any regulatory agency, plans to prepare and submit one are in place to mirror customer progress through their drug development processes.
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.