Survey analyzed more than 1,000 responses concerning microbiological methods
The biopharmaceutical industry is one of constant, steady improvement. Yet, despite being on the cutting edge of science, there are areas, like quality control microbiology that can be resistant to change. Intense regulatory scrutiny and pressure from manufacturing caused a great deal of inertia in this segment, especially when it involved decisions introducing modernized or rapid test methods. While the benefits of rapid microbiological methods are clear and encouraged by regulators in recent years adoption had been painfully slow. Comparatively, the global pandemic has prompted new interest, if not demand, for rapid microbiological testing methods, especially with relation to the development and global distribution of COVID-19 vaccines.
Due to COVID-19, biopharma companies experienced shutdowns, reduced headcounts and supply shortages just like many other consumer and retail companies. The benefits of modernized microbial methods were evident in the face of increased manufacturing pressure, changing market demands, and limited staff. In a recent market report, it was predicted that the rapid microbial method test market worldwide is expected to grow a CAGR of 5.8% following the unparalleled events of the pandemic. Ultimately, we saw many companies quickly adapt and respond to this by making the leap to rapid microbiological methods very quickly.
In this article, we are taking a look at the information we collected and making a future analysis of some of the market drivers that are expected to influence microbiological quality control laboratories within the industry. In other words: how is quality control shaping their decisions when it comes to implementing alternative, rapid methods, process improvements, and meeting evolving regulatory expectations? We surveyed just over 1,000 customers around the globe, and ranked their key decision-making factors below, in order of importance (first being the most important).
1. Data Integrity
The days are numbered for testing methods involving 4-eyes approval. The validation and credibility of data collected are the most important aspects of a confident decision-making process in quality control. QC scientists (and regulators) are beginning to more frequently ask, why leave ourselves open to possible human error when the process can be fully automated? With the iterative removal of manual readings in place of instrument-based analysis, data is not only more accurate, but the process is up-to-speed with the rest of the industry. Staying on top of trends within the industry to ensure data integrity is more important than ever in preparation for future potential uncertainty, as we have seen in the last year. Our customer survey shows that data integrity plays one of the largest roles in key purchasing factors globally, only next to budgetary requirements (for North American customers, at least). It’s no surprise that companies are taking this issue very seriously when 23.9% of all Food and Drug Administration (FDA) 483 warning letters in 2019 were related to records and reports (FDA). The cracking down of data integrity violations is becoming a strong driver for implementing rapid methods, especially those that can provide audit trails, automated analysis, and results reporting.
2. Contamination Control
Technically, this is what it’s all about isn’t it? Minimizing the risk of releasing drugs to market that are dangerous for patients, and ultimately, the reputation of the product’s name and company. The US Centers for Disease Control and Prevention (CDC) states that at least 3.2% of patients fall victim to one hospital acquired infection (HAI) per day (Sterility Testing Market). It is of critical importance that the manufacture and distribution of sterile therapies and medical devices be maintained. This has created a growing need to meet higher sterility assurance regulations across the board, and particularly within the drug manufacturing process. With an automated testing process removing subjectivity in results, QC analysts can assure they’re meeting sterility standards. Not to mention, manufacturers save thousands on what could’ve been a product recall, or a potential lawsuit. Not surprisingly, of the six FDA citations that saw dramatic increases in usage between 2018 and 2019, control of microbial contamination made the top three.
A market driver in virtually any industry is efficiency. Making cost-effective, timely decisions to increase productivity, cut overhead and drive ROI is “business 101”. But why is this new for our post-pandemic situation? Vaccine development, in the last year, has been put in the spotlight. Citizens around the world are now made aware of the lengthy and complicated process of approval and the ultimate release of a safe vaccine. The world wants a fast solution, but there is no room to sacrifice quality. Rapid sterility results of <7 days, as opposed to the compendial sterility method of 14 days, ensures a faster time to the patient. This reduces inventory and storage requirements, detects contamination failures sooner, and ultimately improves overall operations to release product in half the time. In addition to the cost-savings and reallocation of previously wasted resources, this alternative method brings about a better standard of living for all when more patients can be treated sooner.
4. Regulatory Changes
Contrary to popular belief, regulatory agencies have begun to stress that the compendial method should no longer be considered the only option. And, taking things one step further, it’s becoming the least favored option when considering the aforementioned data integrity risks. Regulatory agencies have begun to engage in more and more industry-organized events, such as the PDA Rapid Microbiological Methods Workshop in 2020, where members of the FDA, CDER, and CBER participated in focused “Ask the Regulators” roundtable discussions.
With many organizations shifting to rapid microbiological testing it leaves many other companies wondering “Why aren’t we doing the same thing”? As the industry changes and the regulatory landscape evolves, best practices are constantly improving as well. Regulators in charge of this landscape, often look to companies already implementing leading practices and seeing successful, more efficient procedures make positive improvements on patient safety and operational efficiency. When regulators observe the best-in-class manufacturing and quality control techniques, the bar is then set higher and higher with each modernized testing approach. This leads to other companies wanting a piece of the pie and figuring out ways to implement new practices within their workflow. Along with efficiency, companies want to be able to show that they’re utilizing the best methods out there.
5. New Therapeutic Applications
mRNA-based therapies and cell and gene therapies have gained more attention over recent years, and will continue to grow in the next post-pandemic world. Moreover, mRNA-based therapeutics are a hot topic within the industry and have entered the public conversation with the first-to-market COVID-19 vaccines by Pfizer/BioNTech and Moderna. It is well known that the benefits of this type of therapy outweigh those of traditional procedures including higher efficacy, faster development time, and lower cost to produce. Despite the breakthrough in medical science these provide, mRNA therapies are still reliant on growth-based quality control methods requiring unnecessarily long incubation periods to allow colony-forming units (CFU) to be visible by humans. This leads to days or even weeks of wasted time as the samples could have been through a quicker incubation process with an alternative method. Unless the process is automated, microbial contamination tests are operator-dependent, which requires training and less staff being used for other processes that cannot be automated. With the need for faster implementation of the product to the patient, the compendial method is less beneficial for testing.
6. Global Harmonization
A concept that many companies have struggled with over the years, the need for global harmonization is at an all-time high. Local regulations, differences in procedures from site-to-site based on product, and varying sizes of individual sites are some reasons as to why this feat has been difficult to overcome in the past. Due to recent events, we’ve seen that this concept is now a priority in the biopharma market. Let’s think about it in terms of COVID-19. With the massive surge of patients on ventilators, the demand of ventilator-related drugs (i.e. sedatives) needed for the intubation process sky-rocketed. This put supply in drastically low numbers, and companies manufacturing these drugs (and medical devices) couldn’t keep up. This forcedGlobal Harmonizers, driver in pharma development pharma manufacturers to quickly bring on other sites to fill this gap in supply. With harmonized procedures in production and quality control testing methods across the globe, sites can have similar, if not identical production abilities and go-to-market times. This would allow a manufacturing site in, say Japan, to quickly reconfigure their production facility and support production for other sites in other countries that are falling behind.
However, harmonized production procedures are only one part of the solution. Quality control testing methods should also be harmonized to ensure stability in production supply and reduce time to release through rapid methods. Companies undertaking the task of global harmonization should consider maximizing their efforts by implementing the most modern methods, rather than traditional methods, as a key goal in these endeavors. While this may require additional work up-front, these companies can begin realizing the time and resource savings of rapid methods sooner, while avoiding the cost of having to repeat validation or technology transfer at each location one-by-one later on.
The COVID-19 pandemic put new pressure on the global biopharma supply chain due to the need for speed. We’ve also witnessed first - hand how, in the face of new pandemic-induced priorities, previous sustainability initiatives took on an additional definition from “green sustainability” and became more and more aligned with survivability or business continuity. Driven by a surge in public demand and depleted inventory of commonly used supplies in biopharma manufacturing like surgical masks, testing swabs, and even alcohol-based disinfectants, many companies had to seek alternative suppliers just to maintain standard operations. This revealed vulnerabilities in supply chains and standard business operations, because as infectious and chronic diseases have grown exponentially over the past decade, we have witnessed increasing demand for therapeutics to treat these emerging diseases. This will become a major driver of the market post-pandemic as companies ensure they can shore up their operations, supply chains, and manufacturing capabilities. We’ve already seen how the availability of resources, both material and personnel, dwindle rapidly.
As we prepare for the unavoidable obstacles of entering a post-pandemic industry, Charles River believes in the power of partnership. We’ve tailored our solutions to meet the needs of the industry, while keeping what’s best for the patient, and others utilizing our products, a top priority. With state-of-the-art testing facilities, consulting experts and equipment (such as rapid microbiological methods) we’re here for you every step of the way.
This post is related to:Quality Control/Analytical Testing