Ajay Dubey, director, marketing, Ingenesys

Typically, installation of highly automated systems at a client site takes nothing less than a week or two. Pune-based, Ingenesys, has made an exception by reducing this turnaround time to approximately four days. The company has recently invested in a dedicated factory acceptance testing (FAT) center for live testing of their systems. The customers are given the opportunity to see these systems fully operational and tested before being installed at their respective facilities. In an interview with BioSpectrum, Ajay Dubey, director – marketing, Ingenesys (a venture of the DD Enterprises), throws light on the company's strategy and major investments that could help customers achieve clearance of stringent regulatory supervision.

Q Ingenesys has been catering to the biotech industry for many years. Which segment of the industry has been favorable for your business?
Dubey: The entire Indian biotech industry has been favorable for us. This industry has two verticals: the conventional antibiotic and large-volume small-value fermented products and the small-volume large-value therapeutic proteins, or biologics. Operationally, the similarities between the two are few. Ingenesys straddles the whole chasm.

The biotech industry in India is technology and regulations driven, IPR guarded, capital intensive, with a market that is still evolving, especially the biologics segment. Like the biopharmaceutical operations which have evolved primarily after delving in the conventional products, Ingenesys too has graduated from mass produced stainless steel equipment to precisely engineered automated systems that make routine human interface redundant. Our strength is our expertise in understanding the customers' technological needs, delivering their expectations and in programing validatable software which can pass the scanner of the US and European regulators.

Q The vaccine sector is driving the growth of the biopharma industry in India. How is your company gearing up for that growth?
The vaccine segment falls within what we generically call the biologics. They do not differ in any of the attributes, save the fact that the volumes being handled are smaller compared to other biologics such as insulin or monoclonal antibodies. Although we do not prescribe to “one design fits all� approach, the vaccine production does not offer any bigger challenges than what we expect from the biopharma industry.

Q What have been the achievements of Ingenesys over the past one year?
We have had the opportunity of designing and supplying equipment and systems for a diverse range of products including monoclonal antibodies (mAbs), vaccines and blood plasma. The testing of all the equipment at our FAT center enables our customers to see their systems fully documented, operational, and tested before being installed at their facility. Our plug and play approach has enabled us to offer substantial savings to our customers with reduced turnaround time for installation and lower requirement of resources to complete these activities at the site.

Q What were some of your key infrastructure-related investments?
We have invested in a dedicated FAT center for live testing of our systems. We are in the process of upgrading our legacy systems by implementing an enterprise resource planning solution for streamlining all our processes for effective monitoring and control of our projects. We have planned substantial investments in imparting training to our team members to ensure our presence as a key player for meeting the requirements of the global biopharmaceutical industry.

Q There are many biotech companies in India who are looking at monoclonal antibodies? Will that be a growth driver for Ingenesys?
Monoclonal antibodies as a group brought in $51.16 billion revenue globally in 2010. New mAbs that are in development require extensive product-characterization for the product to obtain the necessary approvals for clinical trials to proceed and eventually to be released into the market. These two factors make the whole future of biopharma extremely exciting as well as challenging for us. We anticipate two changes to happen in India - structurally as well as philosophically. Structurally, upgrade of existing facilities and contract manufacturing is the way forward. We see opportunities in both. Philosophically, this is a game that needs serious players, as not only are the investments large for our clients, but also are the cost of errors that run into double-digit crore with time.

Q How do you help your clients to comply with regulatory approvals?
Offering and passing factory acceptance tests of the critical equipment of the operation is our ingrained strategy. Since we understand this, our designs and fool-proofing takes the center stage. Additionally, during the FAT we recommend that the client deputes its key operating personnel to get a full training on the system for both hardware and software.

Q What is Ingenesys' future strategy?
Upgrading ourselves with the latest trends and a continuous training for our front-and-back office staff will be both our capital and insurance. We hope to double our revenues by 2014.

Nayantara Som Banerjee in Mumbai