A major goal in high-performance liquid chromatography (HPLC) over the past decade has been to develop particle technologies that provide enhanced separation efficiency. The benefits of increasing efficiency include faster analysis times and enhanced resolution. The trend began with the development of smaller particles (generally termed sub-2 ┬╡m) and the instrumentation advances required to handle the resultant high-pressure requirements, dawning the age of ultrahigh performance liquid chromatography (UHPLC). Moreover, liquid chromatography and UHPLC coupled with mass spectrometry detection constitute the most promising strategies to achieve high-throughput and/or high-resolution analyses in a drug-discovery environment.

Indian Market Dynamics

The Indian HPLC market in 2014 is estimated at Rs.755 crore, with 4300 units. Fast liquid chromatography (LC) systems are increasingly being preferred owing to the growing need for high-throughput separations, which are able to cope with the analyses of a large number of compounds in very complex matrices. Specialty systems, comprising gel permeation chromatography instruments, supercritical fluid chromatography instruments, bio-LC, and ion-exchange chromatography instruments cater to niche demand.

The key driver has been investment made by the pharmaceutical industry. The top five pharmaceutical companies, Sun Pharmaceutical Industries Limited, Aurobindo Pharma Limited, Dr. Reddy's Laboratories, IPCA Laboratories Limited, and Mylan purchased more than 100 systems each, and they are expected to maintain this trend over the next couple of years. 2015 shall see more companies in the fray with similar levels of procurement, including MSN Laboratories and Torrent Pharmaceuticals Limited. The academia and research segments, largely supported by the government, did not see much activity.

The upcoming quality-by-design (QbD) methods are being embarked upon to enhance robust manufacturing process, to facilitate product quality, and to manufacture products in line with six-sigma. Researchers and operators in laboratories are performing more number of experiments for cross validation, contrary to the number of experiments being performed earlier. The increasing number of experiments is directly impacting the surging preference for cross compatible HPLC systems. Citrix-metaframe-based software application is expeditiously changing the HPLC labs by simpler administration, optimizing the network bandwidth, and load balancing. The trend of improved IT tools is gaining prominence in HPLC systems. Integrated HPLC systems have proposed a completely new operating environment and realize a PC-free laboratory by enabling control of the instrument from a smart device, such as a smart phone. Research and analysis of large molecules that are likely to go off-patent in the next 4-5 years is gaining prominence in India.

Technology Developments

Not long ago, chromatography automation meant strip recorders and peristaltic pumps. Few people would now consider that to be a true automation and even fewer would settle for binders full of strip-recorder paper reels. Automation is becoming intelligent and in the process it is making our workflows smarter. Ongoing developments in ultra-performance liquid chromatography and ultrahigh performance liquid chromatography technology are making seamless integration into the existing laboratory systems much simpler.

Superficially porous particle technology. Superficially porous particles have become a major platform for the development of high-performance liquid chromatography columns. Since their modern introduction in 2006, most major column manufacturers have adopted the technology. A number of particle sizes and a variety of chemical modifications are now available. Sub-2 μm versions of SPP-based columns have been developed that combine both the efficiency advantages of the smaller particle with the architecture of the core shell. Additionally, 5 ┬╡m SPP sizes have been developed by several manufacturers. These larger particles allow more direct transfer of classical 5 μm applications, such as USP methods, to the newer technology. Most recently, the focus in the industry has been moving toward the adaptation of SPP technology for large molecule separations.

Ultrahigh performance liquid chromatography. UHPLC has recently become a widespread analytical technique in many laboratories, which focus on fast and sensitive bio-analytical assays. Modern UHPLC systems have important advantages over previous generations of HPLC systems. The key advantages include increased speed of analysis, higher separation efficiency and resolution, higher sensitivity and much lower solvent consumption as compared to other analytical approaches. Fast gradient applications by UHPLC/UV systems are easily adopted in QC/QA applications. All this is enabled by specially designed instruments and sub-2 micron particle-packed analytical columns.

Improved software. Current chromatography data systems (CDS) come in a variety of shapes and sizes. From the perspective of regulatory compliance and practical use of the system, a networked CDS solution is the only option that should be considered for regulated laboratories. With a networked system, data can be acquired on one instrument, but processed on a different workstation in an office because the data are available via a central server. In addition, a networked CDS has one or more data servers located in the laboratory to buffer data, add resilience, and avoid data loss. Using the currently available technology, a virtual network server, rather than a physical server, could be used to store CDS data on a network even for a single instrument. Nowadays, this redundancy is achieved in CDS with the incorporation of a data server in the laboratory to buffer data in case the network is unavailable; this practice should be continued in the future.

Way Forward

Automation system of the future will give the best conditions for the first, second, and third columns; and then assemble them into a multidimensional chromatography method. For many applications, chromatography will become like sample preparation. Being able to do separation, visualization of protein, and even quantitation to let one know how much there is, all in an automated way, becomes a very interesting idea for the laboratory of the future.

Indian Market Dynamics is based on market research conducted by Medical Buyer in May 2015.


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