Manufacturing and Purification

XYNTHA was designed with viral safety in mind1,2

Albumin-free

XYNTHA® is completely albumin-free from the start. An albumin-free cell culture contains recombinant insulin, with no materials derived from human or additional animal sources.*

*The chemically defined cell culture medium in which the Chinese hamster ovary (CHO) cells are grown contains recombinant insulin but does not contain any materials derived from human or added animal sources.

Non-factor VIII process-related components (NPRC) such as proteins, nutrients, and salts.


Initial purification

XYNTHA goes through a purification process designed with viral safety in mind to help remove any unwanted materials, including potential viruses.*

*The chemically defined cell culture medium in which the Chinese hamster ovary (CHO) cells are grown contains recombinant insulin but does not contain any materials derived from human or added animal sources.

This medium contains NPRC such as proteins, nutrients, and salts.


Synthetic ligand

XYNTHA uses a synthetic ligand instead of animal-derived molecules. The manufacturing and purification process is designed to reduce the risk of viral contamination.

 

 


Nanofiltration

XYNTHA utilizes a 35-nanometer pore-sized filter to further eliminate contaminants and reduce the chance of viral contamination.


Manufacturing and purification

Watch the video for more information on how XYNTHA is made.


Potency and monitoring
  • Manufacturing reference standard calibrated against the World Health Organization (WHO) 7th International Standard for factor VIII activity using the one-stage clotting assay
  • The potency expressed in International Units (IU) is determined using the chromogenic assay of the European Pharmacopoeia
  • Clinically monitored using the one-stage clotting assay

When clinically indicated, patients should have plasma factor VIII activity levels monitored by the one-stage assay to confirm that adequate factor VIII levels have been achieved and are maintained.