All about CMC

Learn about CMC analysis & quality control news and their importance to ensure precision, quality and safety when developing new pharmaceutical products.

What happens to batch testing and batch release after Brexit

Kymos complies with FDA & EMA inspections as well as GLP, GMP and GCP standards. In particular, as a GMP certified CRO, we take the responsibility tosupply manufacturer authorisation for quality control purposes. In this guide, Kymos helps outline the current situation of Brexit and what this means for batch testing and batch release after Brexit. (...)

By Joan Puig de Dou|2024-08-14T11:16:45+02:00October 4th, 2019|CMC, News|Comments Off

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 step approach: 1. Production of the HCP antigens This phase is carried out by the client in a mock run (...)

By Joan Puig de Dou|2024-08-14T10:47:33+02:00May 17th, 2019|CMC|Comments Off

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 by the end of the year. The guideline clearly states that regulatory applications based in literature to demonstrate safety and efficacy (...)

By Joan Puig de Dou|2024-08-14T11:13:41+02:00April 28th, 2019|Bioanalysis, CMC|Comments Off

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 of the type of the electrophoresis, different quality attributes of the protein can be measured. Sensitivity, robustness and throughput will (...)

By Joan Puig de Dou|2024-08-14T10:44:40+02:00April 28th, 2019|CMC|Comments Off

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 the purpose of in-use stability testing is to establish a period of time during which a multidose product can be (...)

By Joan Puig de Dou|2024-08-14T10:49:14+02:00January 8th, 2019|CMC|Comments Off

Elemental Impurities in Purified Water

In line with the Ph. Eur. implementation strategy for the ICH Q3D guideline for elemental impurities, the test for heavy metals (2.4.8) has been deleted and a new section is included: “If purified water in bulk does not meet the requirement for conductivity prescribed for Water for injections (0169) in bulk (1.3 µS/cm), a (...)

By Joan Puig de Dou|2024-08-14T10:45:27+02:00November 4th, 2018|CMC|Comments Off

Heparin Anti-factor Activity Testing

Heparin is a sulfated glycosaminoglycan present as a mixture of heterogeneous molecules varying in molecular weighs used in medicine as anticoagulant. It is present in mammalian tissues and is usually obtained from the intestinal mucosa or other suitable tissues of domestic mammals for food by man. It is purified to retain a combination of activities against different (...)

By Carles Celma|2024-08-14T10:47:01+02:00July 7th, 2018|CMC|Comments Off

Vaccine Potency Assay

Vaccines are biological products intended to deliver antigens with the scope to induce an immune response and immune memory against a particular disease. Vaccines can be prophylactic or therapeutic and generate immunity by humoral or cellular response. Manufacturing of vaccines is a very challenging activity, because the outcome of this process may vary due (...)

By Carles Celma|2024-08-14T11:16:04+02:00May 18th, 2018|CMC|Comments Off

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