What implications for APIs & excipients suppliers?
ICH Q3D Step4 will have to be applied very soon: June 2016 for new Drug Products and
1st January 2018 for all existing DP, making it mandatory for all manufacturers to carry out a risk assessment to control elemental impurities in their DP.
Such evaluation needs to consider all potential sources of Elemental Impurities and obviously, drug product components are probably the most likely contributors.
On January 1st 2018, all new and existing drug products will have to comply with the ICH Q3D guideline for elemental impurities (EIs). Although this guideline sets
specifications for drug products only, the risk assessment approach also involves the determination of metallic impurities in APIs and excipients.
The approach of an analytical CRO
Accelerated stress studies of biotech products can be carried out to study the main degradation pathways of the recombinant proteins to evaluate their stability, or to identify the different peaks / entities observed while running stability indicating separative methods such as ion exchange or size exclusion chromatography.
Fast and accurate absolute-quantification of proteins and antibodies using Isotope Dilution-Triple Quadrupole ICP-MS
Inductively Coupled Plasma Mass Spectrometry (ICP-MS) is used increasingly in metallomic studies to analyze metals and metal species and their interactions within biological and ecological systems.
Access this webinar which presented how the Q3D guideline for EIs can be efficiently implemented for all drug substances, excipients and drug products.
On 1st June 2016, all new drug products will have to comply with the ICH Q3D guideline for elemental impurities (EIs) and on 1st January 2018, all existing products will also have to fulfill the same requirements. Although this guideline sets specifications for drug products only, the risk assessment approach also involves the determination of metallic impurities in APIs and excipients.
Considering the huge number of samples which will have to be tested, Quality Assistance has developed and validated a generic cost effective ICP/MS procedure for the determination of the EIs listed in Q3D.
Our staff of experts is ready to help you to design an appropriate risk-based strategy and to carry out the necessary analytical determinations with our dedicated instruments (5 ICP-MS).
In vaccine production, the quantification of virus concentration is critical for the final formulation.
Cytokine profiling is a powerful tool to link the host immune system with disease pathogenesis...
9th Dec 2014
Lors de cette conférence, les différentes catégories d’impuretés potentiellement présentes dans une substance active d’origine biotechnologique ont été étudiées. Pour chacune d’entre elles, une évaluation de la criticité en termes de sécurité et d’efficacité, une ou plusieurs solutions analytiques et une stratégie de contrôle adaptée ont été présentées. Les anticorps monoclonaux ont été utilisés comme exemple mais les recommandations se voudront extrapolables à d’autres types de protéines recombinantes. Les différents sujets ont été abordés par des experts en ces matières.
Although drug products issued from biotechnology have now been on the market for many years, accurate protein quantification remains a challenge. There are many colorimetric methods for protein quantification (Lowry, Bradford, BCA) but they all lack precision, and suffer from interferences and matrix effects, moerover, the accuracy is highly dependent of the protein used for calibration (...)
Sanofi Pasteur has developed a new construction engineered with a genetically improved glycoprotein sequence. This glycoprotein is produced from a new recombinant cell-line developed in-house from CHO cells. The development of an improved process of production in an entirely animal-free conditions leads to a Drug Substance with a purity greater than 95%. The ability of the purification procedure to remove unwanted host cell proteins (HCPs) should be investigated thoroughly, as should the reproducibility of the process. For safety and tolerance reasons, it is necessary to guarantee that residual HCPs are reduced to an acceptable level in the medicinal product to be administered to the patient.
The objective of this study was to develop an analytical tool that allows monitoring the level of HCPs as closely as possible. Commercialized anti-CHO antibodies were compared by there recognition of HCP profiles in 1D/2D gels followed by Western blots. In order to guide the selection of the suitable antibody for the monitoring of HCP clearance from the process, we also assessed the capability of these antibodies to quantify HCPs in immunoassays. The main challenge of this study was to get rid of the dilution effect observed using different immunoassay formats.