GMP Compliance

Octomab meets all requirements for GMP compliant production! Read why.

Critical Quality Attributes

At HemoSphere Bio the safety and potency of Octomab is assured by constant quality control and validation. This starts at the cooperation with certified suppliers and partners and goes up to production level.

Critical quality attributes are the most important properties, critical to maintain safety and potency of Octomab. One of the core attributes in production is the integrity of the product by purification of functioning molecules. This includes removal of homodimers, mispaired subunits, oxidation-, charge- and size-related variants and other potentially harmful variants and byproducts. Furthermore, removal of process-related impurities is necessary (such as host-cell DNA/proteins, raw materials and leachables/extractables). The same applies to leptospira, mycoplasma, bacterial and viral contamination.

The main attribute for the integrity of the product is its binding potency to factors IXa and X within the coagulation cascade (specific activity).

 

More information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761083Orig1s000ChemR.pdf

CIP/SIP

By design, most pipes and vessels in USP and DSP are single-use and therefore don’t require regular CIP/SIP from the inside. However, protocols are necessary for the cleaning and disinfection of the surfaces and periphery. Our process plant is following the principles of hygienic design to facilitate the process of cleaning and disinfection.

CIP and SIP in our process are mainly related to the chromatography systems. This includes stripping of the columns, flushing with NaOH (MabSelect SuRe™ Protein A-capture and other resins) and equilibration. Validation of the procedure is done by temperature and pH control.