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Dear Readers, Welcome to the latest issue of Micro
Driven by the need to find better therapies and save lives, the pharmaceutical industry has been motivated to invest in scientific advancement. This motivation has however not made it easy for them to bring drug creation to the market as there are a few stages involved. Aside from research, considerable quality management activities are a requirement in order to produce a final version that is both secure and most importantly, effective. In today’s globalized world, innovation should not only be viewed as complementing quality management, rather it is one of the most critical elements that will help shape the future of the generally fast-changing world of pharma.
Throughout history, the pharmaceutical industry has had innovation as its cornerstone. Once upon a time, the 20th century saw the emergence of antibiotics but now the saime industry is providing gene and mRNA vaccines. These changes pushes the industry to the very edge where accomplishments are limited. But today’s pharma innovation is not very limited to drug development, it expands across drug formulation and its delivery systems, advanced methods for personalized medicine and digital health.
If there is one trend which appears the most exciting when we talk about innovation, then it is the developments in the area of precision medicine, which seeks to customize medical treatment to the individual characteristics of each patient, for instance through the use of genetic information, environmental circumstances and lifestyle factors. This way, patients can benefit from therapeutic interventions that are designed to be extremely specific and optimized to the individual patient. This is especially useful in the management of complicated diseases, such as cancer because a blanket treatment approach is not appropriate for all patients due to the diversity of their conditions within the same cancer type.
As a result, pharmaceutical companies are developing more personalized therapies such as CAR-T cell therapy for cancer, which reprograms a patient’s bio-specific immune cells to destroy cancer cells. Technologies for editing genes, eg, CRISPR, can also be extremely beneficial as they offer the chance to resolve the issue of genetic diseases at their origin.
Disruption of drug delivery is yet another focus area that is transforming the pharma landscape. Drug delivery is the most important attribute of a drug for this determinant has an impact on its overall efficacy. To this end, strategies that enhance the delivery and absorption of drugs while at the same time reducing the side effects are being developed instead of the usual oral tablets and injections.
For instance, nanotechnology is being employed in the formulation of nanoparticles for the purpose of drug delivery to sicker cells reducing the risk of collateral damage to surrounding tissues. On the concomitant note, 3d printing of drugs and bioelectronic medicine are enhancing the accuracy of dosages and timing of delivery of drugs consequently, patients receive better and less complicated treatment options.
Integration of digital health technologies, as well as AI is revolutionizing the pharmaceutical industry. There are platforms that have an inbuilt AI-engine for drug discovery, and they are said to be speeding up the process of looking for drug candidates. Also, there are machine learning types of models that can forecast the safety and efficacy of novel compounds even before clinical testing stage.
There are a wide variety of tools available to monitor patients such as smart wearable monitors, tele medicine, and mobile health applications which allow active follow-up of the patients irrespective of their geographical location able to gather data in real time and modify treatment protocols as necessary. The combination of medicine and digital technology in the pharma space enhances the quality of healthcare delivery and lowers the resources needed for and duration of pharmaceutical clinical studies.
Innovation in drug discovery and treatment change is a result of new inventions in this field, but quality control ensures that these new inventions develop better products for the patients. The pharmaceutical industry is the most controlled business on the planete. The FDA, EMA and other regulatory agencies have set rigid boundaries to be followed. It is essential to observe those regulations so as to make sure that any drug developed has the best safety and efficacy profiles.
Formulation of a new drug is a long and tedious procedure which starts with basic research extending to the confines of clinical trials and ultimately ends with approval from respective authorities. Quality Management systems are integrated in the entire process in order that the developed drug is safe for application. This encompasses every step including, but not limited to, checking the concentration and the strength of the drug, and the quality and capacity of the plants used in the production.
In the last few years, with the development of methods such as HPLC, mass spectrometry, and RTRT has enhanced the sensitivity for the detection of impurities giving more assurance of quality at every phase of the manufacturing process. Quality by Design (QbD) principles are also being adopted by many pharmaceutical companies to ensure the optimized process of drug development, decrease variability as well as placing a ceiling on the probability of a defect.
One of the most important functions under quality control is the statutory requirements. There are laws that every drug and pharmaceutical product manufactured or sold must conform to. Such laws apply from the harvesting or extraction of the bulk place to the completion of the final drug dosage form including container closure systems and labeling. Not complying to these standards can lead to legal sanctions, loss of money through retrials and delays of product launches.
Organizations need to have adequate quality management system (QMS) to keep regulatory requirements. Such systems need to ensure sufficient documentation, audit history, and production process tracking on real time basis. Due to the growing impact of technology, companies are gradually shifting to cloud based QMS that greatly improve the company’s capacity to receive, manage, and report systems, making it simpler to maintain a company-wide approval across all production stages.
The application of mechanization processes in the area of quality control in the pharma sector is becoming more widespread. Automated systems are capable of executing repetitive activities with a consistent number of mistakes, given that they perform repetitively such activities. For instance, it is much quicker and easier to inspect packages for defects and dosages for inaccuracies with automatic inspection equipment than with manual inspection. Automated robotic systems are already implemented in the laboratories to conduct repetitive tasks such as preparing and analyzing the samples for testing so that scientists can spend their time on sophisticated problem-solving tasks.
Automation enhances quality control but also enhances productivity aiding pharmaceutical companies to ensure that they are able to satisfy the increasing global demand for quality medicines.
The future of the pharma domain is primarily influenced by the meeting point of quality assurance with innovations. For the new technologies and therapies to be effective, they must be able to integrate new level quality control processes that are never seen before. For example, the machine learning and AI integration within quality control systems is facilitating predictive modeling and data analytics which are more descriptive thus more good at averting critical incidences.
In addition, with the rise of personalized medicine, the systems for quality assurance will have to change to ensure that all customized medicines are built to last as long as those that are manufactured in large supplies. This change towards personalized quality control affects the industry in ways which require different strategies in manufacturing, testing and regulatory control.
As might be expected, it has not been smooth sailing in the events of the new treatments becoming available. The pharmaceutical business is now at a crucial point as it has to balance new innovation with the body’s safety, as well as the quality of the new therapies. As medicine becomes more precise, drug discovery becomes automated and quality management and management of production processes becomes automated – the future of pharma is in quality and innovation at all stages. As these two synergies are mastered, the industry will experience unparalleled growth and deliver new therapeutic remedies to patients everywhere in the fastest and safest manner possible.
