Management

Management

‘Tech’ing forward

Scientific instrumentation and engineering has been the silent force behind the many milestones in the biotechnology industry. Sachin Jagdale reveals more

Biotechnology is today a buzzword in the lifesciences industry. Many difficult to imagine and impossible to implement medical discoveries became a reality because of this highly productive field. Over the years, biotech evolved from being a means of producing basic foods and beverages to its current role as a source of high-value neutraceuticals, as well as therapeutic agents for diseases where the medical community needs alternatives to traditional chemical-based medications.

The commercial exploitation of biological activities calls for the manipulation of systems comprising organisms, tissues, cells and their molecular components, the input ingredients of any biotech operation. Was it easy to work on and intervene among some of the most complex living materials? Of course not. Though biology is central to biotech, the ‘technology’ part has today become a driver of the business of biotech. This is acknowledged by industry stalwarts like Kiran Mazumdar-Shaw, CEO, Biocon who in 2003 had said, “Today anything can be done (because) we have the techniques.”

Biotech is expanding rapidly using a growing set of techniques to extract valuable products from organisms and their cells. Undoubtedly researchers and biologists have made an excellent study of biological science and nursed biotechnology to its optimum levels to come close to the secrets of life. However, the contribution of scientific instruments that are used to make biotech operations faster, highly accurate and productive also cannot be ignored. If researchers are the nucleus of biotech operations then scientific instruments are the electrons that revolve around it. Mutual co-operation among them guarantees the desired result.

As Ajay Ashtekar, Managing Director, Bioasset Technologies puts it, “The biotech that we know today is directly an impact of the tremendous strides taken in the arena of instrumentation and engineering. Many types of equipments and machines are used today in the biotech industry and certainly each one of them has its own importance, where engineering genius has played a crucial role.”

Instrumental effects

“Customers expect ready to use consumables.For example, earlier researchers spent their time and labour in casting gels. Now they can easily get ready to use
pre-cast gels which eliminate inconsistency, between different batches as well as between researchers. Customers now are more focused on reliability and reproducibility of results in the shortest time”

– Dhiren Wagle Country Manager

Bio Rad Laboratories

Behind the benefits of biotech, are instrumentation and engineering techniques.

For example, biotech is today highly dependant on different chromatographic techniques as a separation and purification tool. Chromatography was first invented in 1903 by the Russian botanist, M S Tswett, to separate organic and inorganic compounds. This century-old technique based on differential migration does not have an isolated use. It can be used to decide the contents of liquid or solid mixtures. As per the type of chromatography, functions would vary.

Another technique central to biotech is the Polymerase Chain Reaction (PCR), a contribution of Kary Mullis, which played a pivotal role in sequencing the human genome. The aim was to generate sequences and then bring them together to discover genes and the kind of information stored in DNA. PCR and engineering of automated instruments for analysing nucleic acid sequences have reduced the cost of sequencing considerably. If predictions are to be believed by 2025 the entire human genome could be sequenced for $6000.

Bioseparation is a key part of any biological process and so any technology which makes this faster and more efficient, to increase yields will improve profit margins. For example, the production of human insulin is a lengthy process with 31 major steps, 27 of which are about product recovery and purification. Advanced instrumentation for bioseparation engineering have provided a means to carry out this process on much larger scales. Similarly, proteins can be analysed by using protein analyser kits and lyophiliser is a great analysing tool.

In a similar vein, with time at a premium, advances in ready-to-use material have made the researcher’s work much easier. “Customers expect ready to use consumables. For example, earlier researchers spent their time and labour in casting gels. Now they can easily get ready-to-use pre-cast gels which eliminate inconsistency, between different batches as well as between researchers. Customers now are more focused on reliability and reproducibility of results in the shortest time,” says Dhiren Wagle, Country Manager, Bio-Rad Laboratories.

Ashtekar opines, “There are many other equipments and instruments like the gel documentation (Gel Doc) System, amino acid sequencers, MALDI-TOF mass spectrophotometers, microarray systems, mammalian cell disposable fermenters, chromatography systems, membrane separation systems, gene synthesiser etc. which are certainly an engineering marvel and have given a huge impetus to biotech research as well as the industry.” He adds, “However, it must be emphasised that like in any field of science, it is the biotechnologist or end user who has to thoroughly understand the fundamentals to optimise and maximise the use of such advanced instruments. Typically, biotech work requires a battery of such equipments to work either in sequence or in tandem to be of real use.”

Challenges

Instant success rarely happens. Meeting the demands of the biotech industry is not an easy task for scientific instrument manufacturers,e specially since the industry itself is evolving at a very fast pace. Keeping up with scientific research and providing tools to commercialise and take it to the next level, is the real challenge for scientific instrument engineers/manufacturers. Esepcially since if readings are even a fraction off mark, it could bring the entire experiment to a halt. In a commercial setting, this could result in the entire batch being discarded.

There are many external factors as well that scientific instrument manufacturers need to take into consideration. Wagle informs, “In many parts of our country, the power supplied in the labs fluctuate a lot which in turn damages key electronic components of sensitive machines. Uninterrupted and spike free power is critical for the smooth free running of the equipment. Technologies like PCR and many others need uninterrupted power supply while the experiment is on, or else the entire experiment can be spoilt if the equipment stops in between, and hence an Uninterruptible Power Supply (UPS) is very critical to install these equipments.”

Post delivery service is yet another challenge that scientific instrument engineers have to face. As the sensitivity of instruments increases, so does the chances of technical problems. “Our engineers are strategically located throughout the country to respond to customers in the shortest time. Engineers have to undergo training in all the products before they work on any instrument. All engineers are well equipped with specialised tools which help them to rectify the problems in a short time and ensure performance of the equipment is as per specifications,” says Wagle.

One of the instruments which has revolutionised biotechnology is obviously the PCR abbreviated from ‘Polymerase Chain Reaction’. This equipment amplifies the DNA and creates exact multiple copies within an amazingly short span of time. Many versions of this machine are available from simple to advanced, including the RT-PCR. The PCR typically works in three steps of annealing, elongation and denaturation. These steps work in repeated cycles. Each cycle multiplies the number of copies of the gene / DNA fragment of interest. The major applications of the PCR are production of probes, gene cloning and manipulation, amplification of ancient DNA, DNA sequencing, characterisation of rDNA, forensic DNA typing and generation of cDNA libraries.

The gene sequencing machines have been another break through in terms of engineering genius. Highly evolved and complicated systems are being used today with extremely high throughput coupled with complex integration with data bases for the Human Genome Project.

Source-Ajay Ashtekar

Around the table

Both from the customer as well as service provider’s point of view, a prior presentation on the product is very necessary before any sort of agreement is signed. This initial meeting forms the foundation of the future client-vendor relationship. As with any other product, nothing is more important than understanding the needs of the customer. “The engineer needs to understand the basics of the specific topic that is the subject of interaction with the scientist. Likewise, the scientist should have sound fundamentals of his subject to recognise the limitations and also have an alternative approach, to help the engineer find a workable solution,” says Ashtekar.

Speaking from the opposite side of the fence, Dr Aniruddha Pandit, a Professor at University of Mumbai Institute of Chemical Technology (UICT), says, “Instrumentation engineers first should explain the principle of working of the instruments rather than just giving the instruments and their operation and results. Most researchers in biotech companies have a background in biochemistry or microbiology and do not know the physics behind the working of the instrument which needs to be explained.” For example, the researcher needs to understand the range of operation and why this range was chosen, what are the other possibilities to measure the same quantity, what is the accuracy (sensitivity) of the instrument. Based on these parameters, a decision can be taken as to whether the instrument in question is really needed or not.

According to Wagle points like ease of usage, availability of products (consumables) with longer shelf life, low-cost maintenance, uptime, downtime, running cost, Annual Maintenance Contracts (AMCs), Comprehensive Maintenance Contracts (CMCs), ease of contact, after-sales service and technical support, higher reliability, faster throughput, better ease of use, lower costs are some of the key factors that are discussed during the meet. Besides this, issues like systems which use low sample volume documented verification that the system performs as intended in its normal operating environment according to the manufacturers’ specifications like Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), preventive maintenance schedule and procedure of all equipment also have the place on the table of discussion.

It is the duty of researchers to feed engineers with the desired data. However, this is not an easy task. Ashtekar elaborates on the possible tough tasks for researchers. He says, “The field of engineering and instrumentation as applied to biotech is complex. For example, the instrumentation and engineering for developing an instrument for basic research, for instance, a gene sequencer, is vastly different from the understanding required for designing a bioreactor or a chromatographic separation system. Therefore, the onus of making the engineer understand the exact need is on the scientist.” He adds, “This may also mean that the scientist may have to give, what we can say as a ‘basic course’ on the specific topic at hand to the engineer so that he appreciates and understands the matter sufficiently to extrapolate its implementation ability in the engineering realms.”

With mounting competition, is it any surprise that the research community is also wary of parting with information? According to Pandit, “Research scientists pose their requirements to instrumentation engineers with suspicion as they are afraid that details of their experiments will be divulged to a rival group. Hence the need to sign a secrecy agreement arises. This results in incomplete information being given out and incorrect specification of the instruments. Thus trust needs to be developed and the job should be done professionally.”

More to do

A tool is nothing but the extension of a man’s hand and a machine is but a slightly more complex tool. Machines are invented to empower man so that he can move on to bigger things. Ashtekar sums up, “The role of instrumentation or engineering in biotechnology is not just limited to innovativeness in creating instruments or equipment, but in today’s scenario their role in process optimisation and cost reduction cannot be underrated. In fact, I may even say that this is the most critical factor today, as the fulcrum of success and failure of a biotech company hinges on this.”

sachin.jagdale@expressindia.com