Bottlenecks in Nucleic Acid Extraction: A Multi-Industrial approach with HiMedia Labs

Join us in an engaging interview with Dr. Rajas Warke, Director of Molecular Biology and Virology at HiMedia Labs. Dr. Warke plays a pivotal role for HiMedia Labs, focusing on innovative molecular biology solutions and automation.

This interview delves into the challenges of nucleic-acid extraction, the effectiveness of HiMedia's automated systems, such as the Insta NX® Mag24, and their impact across various industries. This conversation promises valuable insights into the evolving world of molecular diagnostics from a visionary in the field.

Please introduce yourself and tell us about your career to date.

I am Dr. Rajas Warke, currently leading the Molecular Biology & Virology Division (HiGenoMB) at HiMedia Labs. Pvt. Ltd., alongside my co-director and elder sister, Dr. Kavita Khadke. My academic journey began with a Bachelor's in Pharmacy. Still, my keen interest in Biotechnology led me to the Worcester Polytechnic Institute in the USA, where I pursued my Master's in the field.

My passion for research drove me to undertake a Doctorate degree at UMass Med, in collaboration with MIT, specializing in Clinical Immunology and Virology. After completing my education abroad, I returned to contribute to my family's business, HiMedia Labs, as a second-generation leader.

In my role, I oversee the development of innovative molecular biology solutions and automated platforms. I also manage the marketing, sales, and operations of our extensive product range, encompassing over 2,000 SKUs. To further enhance my commercial decision-making skills, I pursued an MBA in Family Business Management from the S. P. Jain School of Management, Mumbai. I am constantly seeking ways to improve our company's systems and stay updated with the latest global technology trends.

Dr. Rajas, could you start by explaining the main bottlenecks in nucleic acid extraction that industries face today?

In various industries, there's a notable trend toward adopting Nucleic Acid Sequence-Based Amplification (NASBA) in laboratory workflows. The first step in any biotechnology-based lab analysis is DNA or RNA extraction. The type of specimen and intended downstream applications significantly influence the chosen method to achieve the desired outcome.

To put it simply, you can liken the molecular biology workflow to a computer system's input/output process, where the input command affects the quality of the analyzed data. Similarly, the quality and concentration of extracted DNA or RNA are critical factors in any genetic analysis, regardless of the industry.

There are two primary methods for DNA/RNA extraction: silica-based columns and magnetic bead-based kits. Currently, the field of automation in nucleic acid extraction is becoming crowded with various instrumentation options. However, there's a noticeable lack of high-quality kits that are tailored to specific sample types. These can include clinical samples, food matrices, biopharma liquids, forensic samples, cosmetics, and more. Addressing this gap by developing kits that are specifically designed for these diverse sample types is essential.

Image Credit: Gorodenkoff/Shutterstock.com

Could you elaborate on how HiMedia's automated DNA/RNA extraction systems, such as the Insta NX® Mag24, address these bottlenecks and revolutionize nucleic acid extraction in various industries?

HiGenoMB-HiMedia has always expertitised in the domain of laboratory solutions, catering to the diverse needs of various industries. Our product range includes instruments and kits designed for different sample processing capacities. The Insta NX Series of Magnetic Automated Extraction features the Mag16, Mag32, and Mag96 models, with the number indicating the maximum number of samples each can process.

Uniquely, the Mag24 model is engineered to handle higher sample volumes, up to 5ml per sample. This capability is particularly beneficial for oncology testing, which often requires processing larger initial sample volumes, necessitating a specific instrument design. The Mag24 is ideally suited for such applications.

However, the versatility of the Mag24 extends beyond oncology. It's also used in various other applications, such as automated midiprep plasmid DNA extractions for research and vaccine industries, as well as in agriculture for screening numerous samples simultaneously for infections and even in food diagnostics. The ability to handle bulk samples effectively is made possible by the specific kits we design, making this instrument adaptable across various industries.

Can you discuss the specific features of your automated systems that ensure high-quality, efficient, and reliable DNA/RNA extraction? In particular, what are the unique advantages of using magnetic bead-based systems in nucleic acid extraction, and how do they compare to traditional methods?

Traditional DNA extraction methods relied on a precipitation technique using Phenol and Isopropanol. This method was not only cumbersome but also involved handling hazardous chemicals. Over time, this approach was largely replaced by the spin column-based method. The spin column approach can be likened to using a fishing net, where nucleic acids are trapped in a membrane and then separately eluted out.

In contrast, the magnetic bead-based approach is akin to using a fishing hook. In this method, DNA molecules bind to magnetic particles and are subsequently eluted out. Our extensive research and comparative studies have shown that the magnetic bead-based approach is more specific and sensitive for DNA extraction across various sample types. When combined with automation, this method significantly reduces manual errors and saves time compared to other methods.

At HiGenoMB-HiMedia, we have developed user-friendly, pre-filled cartridges that further minimize human intervention. These cartridges enable the simultaneous processing of multiple samples, streamlining the workflow and enhancing efficiency in the laboratory.

How does HiMedia Labs ensure that its Automated DNA/RNA Extraction systems stay ahead of the evolving needs of multi-industrial users?

We at HiGenoMB-HiMedia are firm believers that the true potential of automation systems in nucleic acid extraction is unlocked only when they are paired with the right kits. These kits are crucial in bringing the scientific precision and efficiency needed in the extraction process.

Our dedicated team, comprising both engineers and extraction experts, works tirelessly to develop automated solutions that are not only sensitive and user-friendly but also tailored specifically to meet the unique requirements of each sample type and the specific needs of our customers' applications.

What sets HiGenoMB-HiMedia apart is our unique formulation of buffers and the meticulous design of our protocols for the instruments. This attention to detail in both hardware and reagent design is what makes our automated solutions stand out in the field of nucleic acid extraction.

With the increasing need for rapid diagnostics, how do your systems support the urgency in pathogen detection and precision medicine?

HiGenoMB-HiMedia has achieved a significant milestone by filing a patent for processing a maximum number of COVID samples in a remarkably short time — 96 samples in just 11 minutes.

During the COVID-19 pandemic, we played a crucial role by contributing to at least 25% of the COVID testing in India, both in government and private sectors. Additionally, our products were in high demand internationally, thanks to our innovative approach of using pre-filled plates combined with the fastest protocol settings on our instruments, proving especially vital during the pandemic's peak.

Our systems and kits are custom-designed to meet the specific needs of our customers. This bespoke approach and our technical and operational expertise position us exceptionally well in the Clinical Rapid Diagnostic industry. We pride ourselves on delivering efficient and tailored solutions that respond effectively to the urgent demands of health crises like the COVID-19 pandemic.

How do you envision the future of automated nucleic acid extraction technology in improving the accuracy and efficiency of diagnostic processes?

Common challenges in nucleic acid extraction include a limited number of technical staff, high staff turnover, and the use of different processing protocols across various commercial kits. These factors often lead to variability in the purity and yield of extraction results, even for the same sample.

Additionally, achieving repeatability and reproducibility of results between trained technical staff and across different laboratories is a significant concern. Each laboratory strives to mitigate this variance caused by human factors.

By reducing or minimizing human intervention during testing, more accurate and efficient results can be obtained. Automated extraction platforms play a crucial role in this regard, enhancing the precision and effectiveness of diagnostic processes. The implementation of automated nucleic acid extraction technology is key to improving the reliability and consistency of diagnostics.

Image Credit: Rost9/Shutterstock.com

What are the most exciting developments in molecular diagnostics, and how is HiMedia positioned to contribute to these advancements?

One of the most significant advancements in molecular diagnostics is the development of POCT (Point-of-Care Testing) technology, which automates the entire process from sample insertion to obtaining results. This technology holds great promise for making advanced diagnostic tests widely accessible, particularly in developing and underdeveloped countries.

However, a major challenge with current POCT technologies is their high cost per sample, which often limits their use to select groups or relies on funding from global healthcare projects. In contrast, developed countries benefit from robust logistics networks, ensuring that samples from remote areas reach major diagnostic labs in good condition and within a reasonable timeframe.

In developing and underdeveloped countries, the situation is starkly different. Due to inadequate infrastructure, samples often get spoiled or face delays in reaching diagnostic facilities. In such contexts, POCT platforms that require minimal or no technical expertise can be revolutionary, enabling healthcare accessibility across all regions of a country.

Recognizing this need, HiMedia has been dedicated to working on this front for several years. We are in the final stages of developing an affordable POCT platform and diagnostic kit.

This automated, expertise-free solution at a reasonable cost has the potential to empower clinicians and veterinarians significantly. They can focus on choosing the appropriate POCT RT-PCR tests without the burden of worrying about the patient's ability to afford the diagnostic test.

Lastly, how does HiMedia's approach to nucleic acid extraction contribute to a broader understanding and management of diseases in diverse fields like clinical diagnostics, environmental testing, and food safety?

HiMedia recognizes that, in the post-COVID-19 era, clinical molecular diagnostics have become a fundamental component of medium to large scale laboratories worldwide. To fully leverage this widespread adoption of fast and sensitive testing methods, there's a growing need to implement more RT-PCR based assays on these machines at affordable costs.

At HiMedia, we are developing QR code-based online reporting software. This innovation aims to enable immediate monitoring of the first outbreak, its location, the number of cases, and the direction of its spread. Such real-time data is crucial for government agencies to implement infection containment procedures swiftly.

Speed and simplicity are also essential for environmental monitoring and food safety, where testing often requires minimal technical expertise. Environmental samples are frequently collected far from established labs, and the food industry cannot afford lengthy waits to release batches of manufactured items. However, both sectors face competitive pressures and often struggle with increasing quality control (QC) testing costs.

In the realm of food safety, POCT platforms can be a game-changer. Government officials and diagnostic labs can deploy them directly in marketplaces to ensure vendors comply with necessary product cleanliness standards.

Therefore, at HiGenoMB HiMedia, we are dedicated to developing and implementing lab- and POCT-based molecular assays. These assays are affordable and easy to use and maintain high standards of sensitivity and specificity, catering to the diverse needs of the environmental and food industries.

Where can readers find more information?

• HiMedias website – https://www.himedialabs.com/in/molecular-biology.html

About Dr. Rajas V. Warke, Ph.D., M. B. A

Leading one of the most technologically advanced branches of HiMedia Laboratories today is the youngest director, Dr. Rajas Warke. The Molecular Biology Division currently headed by Dr. Rajas with Dr. Kavita Khadke as his co-director. After earning his Doctorate Degree in Virology & Immunology from the esteemed University of Massachusetts and Masters in Biotechnology from Worcester Polytechnic Institute in USA he decided on coming back to India to spearhead the Company’s Molecular Biology and Virology Division.

He further went on to earn the MBA degree from the well acclaimed S. P. Jain School of Management, Mumbai. He was also an Adjunct Research Scientist at the Haffkine Institute for 8 years. Over 30 Research Publications in Internationally peer reviewed journals, 2 book chapters and 5 patents to his credit to this date are testimony of his hard work being recognized and accepted world over. The rich blend of Molecular Research and Product Management and 12 years of hands on experience in the field now, makes him handle both responsibilities as a Technical Director and Marketing Decision Maker.

Dr. Rajas Warke has led the Molecular Biology Division at HiMedia to one of the prominent contributors for bringing in state of the art Instruments and Innovative technology like Genetic Sequencing & Bioinformatics for the company. Dr. Rajas has been successful in heading his young team at HiMedia towards bringing Automated and Complete Solution for not only Clinical Diagnostics but also for the Food, Water, Plant, Soil, Veterinary and Research Industry to India.

Development of various types of PCR kits and platforms which provide Rapid, Accurate, Reliable, highly Sensitive, Specific & Portable diagnosis of diseases in tropical countries has been Dr. Rajas’s mantra. He has taken charge of the Molecular Biology Division with a vision to develop path breaking and cost-effective solutions in this field. His infectious enthusiasm and determination continue to inspire his team to work harder each day.

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