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Optimization of Pharmaceutical Production Process - Oncology

Optimization of Pharmaceutical Production Process - Oncology

Optimization of Pharmaceutical Production Process
Optimization of Pharmaceutical Production Process. Source: Y. Chen et al. Digital Twins in Pharmaceutical and Biopharmaceutical Manufacturing: A Literature Review, Processes, 8, 1088, 2020.

Epirubicin is an anthracycline #chemotherapy drug used to treat various types of #cancers like #breastcancer, #ovariancancer, and #lungcancer. The #microbial production of epirubicin involves #fermentation of the streptomyces peucetius bacteria at the optimum #incubation period of 7 days.

Chemical structures of the clinically used anthracyclines in breast cancer treatment and their mechanism of action.
Chemical structures of the clinically used anthracyclines in breast cancer treatment and their mechanism of action. Source: A.M. Tőkés et al. Tumor Glucose and Fatty Acid Metabolism in the Context of Anthracycline and Taxane-Based (Neo) Adjuvant Chemotherapy in Breast Carcinomas, Frontiers in Oncology, 12, 2022.

Like other chemotherapy drugs, it can have several production-related problems that may impact its efficacy and #safety. Some of the general production problems with epirubicin are as follows:


1. Impurities: During the synthesis of epirubicin by fermentation of the streptomyces peucetius bacteria, impure raw materials like maltodextrin, yeast extract, glucose, soya peptone, soybean flour, corn starch, monopotassium phosphate, calcium carbonate, agar, sodium chloride, and calcium chloride can lead the impurities to be carried over into the epirubicin or reduced #yield. Further, these impurities can affect the drug's potency, #stability, and safety profile. Therefore, there is a need to ensure rigorous #purification and #qualitycontrol procedures to minimize the presence of #impurities.

Classification of impurities
Classification of impurities. Source: K.T. Liu et al. Quality Management and Quality Control - New Trends and Developments. IntechOpen, 2019.

2. Contamination: The improper functioning of the #isolator or #watertreatmentplant leads to contamination of the #manufacturing batch of the epirubicin, compromising the drug quality and safety. Further, inadequate, or improper #cleaning of #equipment and handling of #rawmaterials increases the risk of #contamination.

Some typical sources of contamination
Some typical sources of contamination. Source: A. Fisher, Risk Management of Contamination, Pharma Focus Asia, Issue 19, 2013.

3. Batch-to-batch Variation: Ensuring consistency in the #production batch is essential to maintain the drug's potency and efficacy. The #continuousmonitoring of the total sugar, pH, and packed mycelial volume (PMV), indicators of the fermentation of streptomyces peucetius to produce epirubicin, ensures consistency in the production quality. Inconsistent manufacturing can lead to variations in drug concentration between different batches, making it challenging to control the treatment's outcome.

Time course analysis of epirubicin production
Source: X. Wang et al. Enhanced One-Step Fermentative Production of Epirubicin by Combination of Mutagenesis and Genetic Engineering in Doxorubicin-Producing Streptomyces peucetius, RR: J Microbiol Biotechnol, Vol. 7, Issue 1, 2018.

4. Stability: Epirubicin, like many other chemotherapy drugs, is sensitive to #environmental factors, such as light, heat, and moisture. If not properly stabilized, the drug can degrade over time, reducing its effectiveness and potentially causing adverse reactions in the human body.

Stability during various stages of drug development
Stability during various stages of drug development. Source: M. Pokharana et al. Stability testing guidelines of pharmaceutical products, Journal of Drug Delivery and Therapeutics, 8(2), 169-175, 2018.

5. Quality Control and Validation: Robust #qualitycontrol measures and #validation processes are necessary to ensure that each batch of epirubicin meets the required #specifications and #standards. Failure in quality control can lead to substandard drug quality and potential risks to patients.

Process Validation Sequence
Process Validation Sequence. Source: 21 CFR PART 11.

6. Regulatory Compliances: #pharmaceutical companies must adhere to strict regulations and #guidelines set by health #authorities to ensure the drug's safety and efficacy. Any deviations from these #regulations can result in production issues and may lead to delays in approval or market withdrawal.

Regulatory Compliances
Regulatory Compliances. Source: Literature.

Moreover, the above said production problems are not exclusive to epirubicin but seem to be general challenges the #oncology drug manufacturers may face during drug production. Further, to mitigate the highlighted principal issues, #pharmaceuticalcompanies invest heavily in research, quality control, and #regulatorycompliance to ensure the safety and effectiveness of their products.


If you are experiencing issues with epirubicin or other oncology drugs, to mitigate, it is essential to communicate with Team EnviroChem Services.

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