Pharmaceutical impurity checks, identification, and analytical measurement strategies are essential parts of the manufacturing process. It is essential for optimizing purity, safety, and control over the drug quality and finished products. The impurities are volatile and impactful. Pharmaceutical impurities can develop from multiple sources. It may include raw materials and their contaminants, drug reagents, chemical catalysts, solvents, intermediates, and any other unwanted particles. These can be organic impurities or inorganic components. In both cases, it is essential to eliminate them. These impurities may be present at very low or trace levels in a complex sample. Or, the impure particle may be a highly sensitive one. There are more than one evaluation and analytical method that help determine the levels of impurity. The testing agents review and collect the data essential to check the relevant risk factors and assess them for better reporting.
- Residual contamination and impurity check – Various ways to evaluate
The best-in-class labs offer end-to-end impurity testing services for the pharmaceutical industry. It is an integral process that helps ensure the optimal quality and safety of pharmaceutical products, especially in cases where accuracy and efficiency are paramount. A comprehensive pharmacopeia analysis can detect mycoplasma and bacterial contaminants. One can also detect vitro and biochemical viruses via lab testing and analysis. The expert testers can design and develop suitable contamination testing plans for several biological products. With their assistance, it gets easy to select the ideal testing solution and pick the customized analysis method apt for meeting specific needs.
- Microbiology and mycoplasma testing
The contamination of bacteria and fungi is dangerous. It can impact the cell and degrade its effectiveness. It is difficult to analyze and obtain contamination reports unless the lab testing facilities are up to the mark. Mycoplasma contamination is challenging to detect, and it directly affects the cells inadvertently. Therefore, it is very critical to review and identify the sterility level of the cultured cells and sample products. The lab facilities help you detect impurities and contaminants like bacteria, fungi, etc., through mycoplasma testing services.
- Endotoxin testing
Endotoxin is an integral cell wall component of Gram-negative bacteria. This bacterium is toxic to the host. Thus, it is paramount to detect and monitor the content of endotoxin. Otherwise, the bacteria would grow more. One can avoid the adverse reactions of the host in animal experiments, impacting the experimental results. Depending on the new-age testing technology and appropriate testing equipment, one can provide endotoxin testing facilities for customers from various fields and industries, like – research, clinical, environmental laboratories, and pharmaceutical or medical device industries.
- Host Cell Protein (HCP) Assays
Several biological drugs, like antibodies, vaccines, etc., get synthesized via biological systems. There are different types of purification methods. In some cases, there may be a minute amount of host protein residues or HCP in biological samples. HCP in biological products may be in the form of foreign protein, inducing an immune response in more than one way. It develops allergic reactions or other adverse impacts on the body. Thus, it is essential to establish an apt method to detect HCP and monitor the quality of the sampled biological products. One cannot ignore the importance of accurate detection of host proteins in biological drugs. The top lab facilities offer new-age analytical testing solutions like – 2D DIGE-based HCP antibody effectiveness detection service.
- Host Cell DNA (HCD) Assays
Biological products in this context may be living components such as recombinant protein drugs, antibody drugs, vaccines, etc. These are produced through the continuous passage of the cell lines. In industrial manufacturing techniques, the purification process is expansive. One can find a comprehensive approach to dealing with the DNA fragments of host cells. The size and composition of the residual DNA fragments do not have a fixed number. Thus, the stakes are high, and the potential risk is volatile. The impact of the living protein in the component may create an infectious, tumorigenic, or immunogenic growth, or mutagenic development in the body. Drug regulatory authorities across the globe have stringent norms and controls, defining the specific requirements on the limit of DNA impurities. It is an integral step for safety and quality control solutions for biological agents. Different types of antibiotics and proteases get produced during the stages of microbial fermentation. It also needs an efficient solution to detect DNA residues from the host cells. Quality testing solutions offer several advantages, like – high sequence specificity, good reproducibility, and less human interference. It can fetch a reliable detection method for biopharmaceutical industrial outlets during research and product quality control.
Benefits of Impurity Testing Services
It is the need of the hour to identify minor impurities during the process of drug development. Especially with the increasing awareness, one cannot take risks. The norms and regulations set b the authorities and regulatory bodies make it an indispensable choice for industrial units. Analyzing the components to detect and isolate the impurity is the goal of the testing program. What benefits can you enjoy through this process? Read on to explore more –
- Get a chance to upgrade the techniques and scale-up chemical compositions without impurities.
- It fetches a competent solution, helping you follow the GMP process without worries.
- Obtain a chance to improve the quality of clinical trial material and sample checks.
- Well-defined samples and granularity in CMC filings.
- Avoid the possible risks and eliminate the adversities related to impurities.
Ensure better quality assurance – Get accurate reports with the best lab
Pharmaceutical impurity testing is an integral part of the pharma industry across the globe. The state-of-the-art facilities at the lab offer top-notch GMP testing, quality control or QC checks, and batch release testing. Ensure optimal quality and safety of life, and meet the regulations. It boosts industrial and business prospects, enhancing quality, safety, and regulatory standards.
With IRCLASS Systems and Solutions Pvt Ltd (ISSPL), secure the golden chance to obtain accurate reports on quality testing of pharma products. Comply with the norms and industrial guidelines, ensuring optimal quality products for batch release.
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