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Host Cell Proteins Analysis
The development and validation of a process specific assay for host cell proteins (HCP) determination in therapeutic recombinant proteins should follow the specifications contained in monograph 2.6.34 of the European Pharmacopeia in a step by (...) Read more
Quality and Equivalence of Topical Products
On October 18, 2018 the EMA published the Draft Guideline on Quality and Equivalence of Topical Products. On June 30, 2019, the period of Consultation will end and it is expected to be in force (...) Read more
Electrophoresis in Quality Control of Biologics
Electrophoresis is an analytical technique widely used for purity determination and identification of therapeutic proteins. This technique is based in the migration of the proteins under an electrical field according their electrophoretic mobility. Depending (...) Read more
In-Use Microbial Stability
In-use stability testing for multidose products was initially based in the Note for Guidance on In-use Stability Testing of Human Medicinal Products of the CPMP of the EMA, in March 2001. According to it (...) Read more
