In general, how has the use of lab testing instruments for pharmaceutical product analysis advanced over the last 20 years?
Testing instruments have been greatly modernized over the past 20 years to keep up with technology and regulatory changes. Instruments have become more robust and reliable. Dimensional accuracy has been enhanced as instruments are now able to meet tighter specifications allowing for less variability and more stringent control of process parameters.
On the technology side, just like our mobile phones, many laboratory instruments now contain embedded PCs and touch screen graphical interfaces. This has allowed for more advanced features such as built in security settings, complex method creation, and report and method storage. It has also led to an increase in the engineering complexity of instruments. The challenge manufacturers face is utilizing that complexity for useful customer features while keeping the instrument user-friendly and serviceable. Over the past 20 years, Distek has placed a greater emphasis on creating a fantastic user experience. We now spend considerable time designing not only beautiful touch-friendly user interfaces but making sure the user experience (UX) is intuitive and easy to use.
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As instruments became smarter and able to store more data, the industry enhanced its regulatory requirement for data integrity and security. It is very common to have instruments connected to software programs that allow for advanced data and security compliance, as well as easier collaboration amongst global locations.
Globalization is no longer a trend but the reality. The majority of our customers have several locations around the world including less developed regions. Those regions can pose challenges due to poorly controlled environments. Manufacturers have enhanced their designs to perform better under various environmental conditions, such as electrical power variability and poorly controlled humidity. Designs have also been updated to meet other international requirements such as CE and RoHS.
Over this same time period what has been Distek’s mission? How has the company helped the pharmaceutical industry bring safe and effective treatments to market over the last 20 years?
Our mission has been to deliver high quality, innovative instruments and provide top notch support to our customers. Distek was founded by Gerry Brinker, a chemical engineer, in 1976. I now manage the daily operation of the company and I am a mechanical engineer. Our company has always been run by technical people and therefore much emphasis is put on product development and quality. We have built strong relationships with our customers and their feedback helps drive our development to provide tools that help them do their job more effectively and efficiently.
Dissolution testing has been around for over 50 years and is an integral aspect of developing safe treatments for the market. Dissolution testing is a critical tool in research and development, helping to advance treatments and testing new formulations. We support and advance this work with instruments such as our bathless testers that allow faster and more efficient testing, and in-situ fiber optic analysis which allows collecting complete dissolution profiles providing a previously unavailable in-depth understanding of the dissolution process.
We also work extensively in quality control laboratories providing reliable instruments that help to test for batch to batch consistency. During this period, we have developed instruments such as the ezfill 4500 (pre-heat, degas and dispense media), VIP 4400 Vessel Washer, Evolution 4300 and Eclipse 5300 autosamplers. These instruments help to create better defined and controlled processes that limit variability due to various human factors. They also offer great automation and efficiency gains in the laboratory.
We are always keeping our eye on new technologies and over the past 20 years have partnered with universities and pharmaceutical companies to evaluate new technologies which could provide value to a broader commercial audience. Even during failed ventures, the lessons learned have helped to advance our industry.
Specifically, what lab testing equipment and services does Distek currently offer to assist pharmaceutical clients with their product testing and development efforts?
Distek has been providing dissolution testing instruments to the pharmaceutical industry for over 40 years. These include water bath and bathless dissolution testers, media preparation and disposal, in-situ fiber optic UV, bathless tablet disintegration, content uniformity and dissolution autosampling.
As the needs of our industry have evolved, we recently released a line of bioprocessing products. Our bioprocessing portfolio includes our patented BIOne single-use bioreactor for cell culture applications as well an innovative bioreactor control system for both mammalian and microbial applications.
With such extensive experience, Distek is well qualified to meet the unique challenges of our customers’ service needs. Distek provides technical support, validation and calibration services. We offer a full suite of validation and qualification services such as installation qualification, operational qualification, performance verification tests and preventative maintenance.
Looking ahead, are there any product testing and development technologies being developed now that will help pharma companies bring innovative products to the market? How will Distek meet this challenge for its current and future clients?
Distek’s core customer has been manufacturers of small molecule drugs which are chemically manufactured molecules. These products make up most of the drugs on the market today. By contrast, large molecule products known as biologics are becoming more important. We have seen most of our customer base expand into biotherapeutic research and development. As a result, Distek has also expanded its product portfolio to include a single-use bioreactor for cell culture applications as well as a bioreactor control system for mammalian and microbial applications. We have seen great interest in our single-use bioreactor with the ease it brings for converting from conventional glass/stainless steel bioreactors to a single-use solution for upstream development. The BIOne bioreactor allows the use of similar film material used in scale-up and production sized bioreactors, assisting in the transition to manufacturing. Another major innovation in our bioprocessing portfolio is in the ease of use. End users should be able to use the entire system with minimal training.
Our primary customers continue to be small molecule pharmaceutical companies and we are always working to provide innovative solutions. Although instrumentation has become increasingly complex during the past 20 years, we focus on ease of use. We continue to introduce advanced features allowing the end user to run their systems more efficiently and capture more information that is required for regulatory compliance while ensuring the systems are intuitive and easy to operate.
Even though dissolution testing is a “mature” and regulated field, there are still opportunities for innovation that we are pursuing, especially in the area of improved In Vivo/ In Vitro Correlation with more biorelevant in vitro test methods.
We also continue to partner with our customers in offering solutions that will help them meet evolving regulatory compliance requirements such as data integrity.