Prompt Praxis Laboratories (PPL)
Tech-Driven 503B Testing Laboratory

On the morning of May 6, 2019, Hyatt Regency in Miami resonated with thunderous applause as Prompt Praxis Laboratories opened its first hospitality suite at Health Connect Partners’ “2019 Spring Hospital Pharmacy Conference.” Prompt Praxis took the opportunity to add a twist to the traditional hospitality suite and showcase its services in the compounding pharmaceutical space. With a wealth of shared knowledge and learning, this hospitality suite represented an unprecedented prospect for the healthcare community to make connections and encourage conversation on ways to accelerate pharmaceutical development. Themed as ‘pharmaceutical testing lab,’ the suite offered a nifty demonstration of Prompt Praxis’ new ‘clean room’ along with other specialized equipment and tools. The other attractions of the hospitality suite included many of Prompt Praxis’ vessels, which were showcased at the ice bar counter. Such a quirky approach to laboratory services not only helped Prompt Praxis garner validation of its prospective clients but also underscored the company’s motto: Prompt Praxis makes pharma fun.

Notably, all the capabilities that Prompt Praxis showcased at the 2019 Hospital Pharmacy Conference could be traced back to the binders of Lisa McChesney- Harris, Ph.D., the founder, CSO and CEO of Prompt Praxis. As an active contributor in the pharmaceutical industry since 1992, Lisa has been part of several large pharma and generic injectable companies, where she worked with numerous in-house and third-party laboratories. For Lisa, the shortcomings of those laboratories sparked the idea of setting up a highly efficient laboratory with the best workflows and equipment for pharmaceutical testing. Additionally, she sought out the best IT systems available to overlay on top of the laboratory infrastructure to ensure data integrity and cut down the lengthy turnaround time. Finally, her dream of the ideal pharmaceutical lab became a reality with the genesis of Prompt Praxis Laboratories in 2011.

The Perfect Partner for Compounding Pharmacy

Shortly thereafter, the New England Compounding Center (NECC) discovered fungal contamination in a particular batch of its products that were already sent to patients, causing a meningitis outbreak. The incident attracted the attention of the Food and Drug Administration (FDA), who stepped in and assumed the primary regulatory authority for monitoring the pharmacy compounders (renamed 503B organizations) and doubled down on strict quality testing of compound drugs. As a result, every 503B company was forced to follow the strengthened standards for non-traditional compounding processes. This sudden change in the compounding services space offered Lisa the opportunity to position her company as the best solution to help this industry navigate the new challenges around rapid testing and support services. Considering her regulatory experience dealing with the FDA and background as a consultant in the field of pharmacy, Lisa was already familiar with the challenges that 503B companies face.

We want to make sure that patients get the highest quality medicine possible, which means the right molecule at the right concentration with little or no degradation

This knowhow guided her to develop the requisite services and data collection protocols that 503B organizations needed to demonstrate compliance with the latest regulatory standards. Since then, Prompt Praxis has offered cGMP testing services for compounding pharmacies, helping them stay compliant with regulatory testing in a timely and cost-efficient manner. “In essence, our comprehensive validation strategy helps in facilitating testing and release of our clients’ compounded pharmaceutical products within 2-4 days,” comments Lisa.

Today, Prompt Praxis is one of the most sought after, fully-integrated laboratory partners offering services for analytical testing, analytical development, validation services, research and development, rapid sterility and BET testing. In addition, Prompt Praxis can quickly initiate client-specific stability tests with existing, stability-indicating test methods along with determinations of pH, particulate matter, visual inspection, BET, and rapid sterility in order to establish beyond use dating and release safe and effective commercial batches.

Leveraging Innovation for Prompt Response

Compounding pharmacy, however, is not the only industry that Prompt Praxis focuses on. Even though the lab is designed to meet the needs of the compounding industry, its services can be offered to the generic injectable industry as well. As Lisa highlights, the common challenge in both compounding and the generic injectable industry is slow turnaround. Organizations often have to wait for weeks or months for results, and even then, they might be unreliable. To solve this problem, Prompt Praxis implemented a patent-pending, digitalized approach which combines the best of current technology to capture and store data.

Prompt Praxis leverages Mettler Toledo’s LabX data capture system and a fully-validated, Waters NuGenesis electronic notebook application, in conjunction with UPLCs (ultra-performance liquid chromatography) that are driven by compliant-ready chromatography data software (Empower 3 by Waters Corporation—a leading specialty measurement company). This tech-driven strategy not only enhances data integrity but enables Prompt Praxis’ quality assurance team to evaluate and monitor the results of its laboratory in real-time. Apart from offering a digitally-enabled laboratory, Prompt Praxis also focuses on the miniaturization of processes to reduce the overall timeline and environmental waste. For example, instead of using a 500 milliliter volumetric flask, the company uses a smaller 10 milliliter volumetric flask for the same sample preparation and testing. The miniaturized approach helps Prompt Praxis save both time and resources in performing tests. “We can test (and have tested) 150 lots of compounded sterile preparations across 18 different molecules, in a single day,” Lisa emphasizes in describing how this approach translates to benefiting her clients.

What’s more, with all its test data stored electronically, Prompt Praxis uses less equipment and fewer employees, resulting in significant output without unnecessary overhead. With its Ready-to-Analyze® test methods, if a client is working with any of the molecules Prompt Praxis has already validated, the laboratory can quickly launch stability or other necessary tests. “Because no further validation of the test method is required, the Ready-to-Analyze method can reduce our client’s time to commercial launch by 6-8 weeks,” states Lisa.

"In essence, our comprehensive validation strategy helps in facilitating testing and release of our clients’ compounded pharmaceutical products within 2-4 days"

A Patient-Centric Approach

As Lisa points out, the underlying belief of such a proactive endeavor is: patients are the true clients of Prompt Praxis. Therefore, Prompt Praxis always strives to ensure that pharmaceutical companies achieve their goal on the first attempt without hitting any roadblocks. Lisa underscores, “We want to make sure that patients get the highest quality medicine possible, which means the right molecule at the right concentration with little or no degradation.” And the same goal is made clear to every team member at Prompt Praxis—from the analyst in the laboratory to senior management. “With a clear understanding of our deliverables, we are all in the same car headed in the same direction,” Lisa adds further.

Although the emphasis on automation allows Prompt Praxis to minimize mistakes, when it comes to handling samples in a laboratory, human error can occur. Instead of shying away from communicating such occurrences, Prompt Praxis takes a proactive approach in informing clients of any incident and develops the necessary course correction. This culture of accountability has enabled Prompt Praxis to earn the trust of all its clients. “The fact that we are transparent, honest, and forthcoming in our interactions with clients offers them an invaluable sense of peace of mind when they work with us,” adds Lisa.

The Promise of a Better Tomorrow

With the possible implementation of the U.S. Pharmacopeia (USP) 797 (standards to ensure compounded sterile preparations are of high quality), large hospital groups are now trying to build centralized compounding pharmacies to distribute medicines to their group of hospitals. These changes would leave many existing and new compounding pharmacy organizations looking for partners for their 503B outsourcing needs. Nonetheless, whether a firm is large or small, there is plenty of opportunity in this space for everyone to be successful. With its solution-oriented philosophy, Lisa believes Prompt Praxis is perfectly positioned to help its clients navigate these changes. She adds, “If an organization is planning to outsource their analytical and microbiological testing, we can help them get to market quickly. Moreover, we can clone our laboratory franchise in other locations if a need arises.” With such determined plans for the future, Prompt Praxis is now poised to become the ‘go-to lab’ for startups and large organizations operating in the compounding pharmacy space.