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Myriad building blocks in biotech research

Cadila has invested around Rs 500 cr to create niche technologies in transdermals, biologics and vaccines

Sushmi Dey Ahmedabad
Last Updated : Aug 21 2013 | 10:34 AM IST
Moraiya, which has come up as a small pharmaceutical manufacturing hub with the facilities of medium and small-scale companies such as Intas and Claris Life Sciences spread across the village, is almost an extension of this city.

As an early entrant, Cadila Healthcare enjoys a certain popularity in the region. That's also because of its large-scale operations, including Zydus Biologics and Cadila's generic division, the Pharmaceutical Technology Centre (PTC), located on either side of the Zydus Research Centre, reviewed in the first part of this report.


Biologics
Zydus Biologics, the biotechnology wing of the company, is the most recent of all its facilities here.

The campus, spread across 100,000 sq metres with three building blocks, is the largest recombinant biotech facility in the country, says the company.

ZYDUS' PIPELINE
  • Oncology
  • Infectious diseases
  • Inflammation
  • Anaemia
  • Osteoporosis
  • Stroke
  • Acute myocardial
  • Rabies

Once inside the gate, the first sight is of yellow earthmovers levelling a patch of field.

This is work in progress for a fish pond, part of the world-class landscaping planned for the campus. The pond, one is told, is meant to cater to the facility's increasing water requirement.


While the company forayed into biotechnology in 2002, the first unit in the campus commissioned operation in 2009, with focus initially on biosimilars or traditional biotech products. Cadila is now experimenting to implement traditional technologies to create novel biologics or new drugs.

"We have moved up from biosimilars to develop novel biologics but by using traditional technologies, where we have built capabilities over the last 10 years. As we proceed, like any company we will evolve to adopt newer technologies," says Sanjeev Kumar, senior vice-president, biotechnology, and head, biologics.

Biosimilars are the generic version of biotechnology products.

Unit-II of Zydus Biologics, 500 metres from the first one, with a capacity of 11,000 litres, was commissioned only in March, to produce new generation monoclonal antibodies, used in anti-cancer medicines.


The entrance and exit of these units are supplemented with rooms having high-efficiency particulate air filters and specified area qualifications in line with global standards.

"These rooms, which also act as change rooms, are primarily meant to rule out any air contamination inside the plant undergoing highly critical development," explains Vibhor Saraswat, senior general manager, manufacturing.

Unit-II has seven levels and is capable of managing development and production of two different products at the same time.

At the sixth floor, there is a control room with a capability to control the entire plant.


The newly built facility is full of huge machines, mostly imported from the US and Europe. According to Saraswat, unit-II alone has around 90 vessels, used for preparation and transfer of media, along with storage of products. These vessels, though manufactured indigenously with supervision of Cadila, use low ferried steel imported from Germany. "One of the crucial things about machines is maintenance," emphasises Saraswat. Apart from vessels, there are other equipment such as freezers and bio-reactors. Cadila has invested around Rs 500 crore to create niche technologies in transdermals, biologics and vaccines.

Right next to Unit-II stands the green-painted formulation unit of Zydus Biologics. "They are just unloading the last machine for the facility," remarks Kumar. Dedicated for manufacturing of biotech products, it is the ninth formulation unit of Cadila across the country.

Zydus currently has 19 products in the pipeline, of which two are novel biologics. Six of these products, developed in Unit-1, are already launched in India and some of the emerging markets. While the company is awaiting the big-ticket opportunity when the US will allow biosimilars, it is gearing up to enter the European market by next year.


Generics
Some four km apart from Zydus Biologics and on the other side of Zydus Research Centre is Cadila's generic development facility, PTC. A wall in the lobby displays the colourful brands of generics manufactured by the company. PTC develops generics for markets in all geographies. The product portfolio is dominated by parenterals, medicines to treat pulmonary disorders, differentiated products, solid orals and injectibles.

Sushrut Kulkarni, who heads PTC, says, "Time and cost are key to generic development and, therefore, there has to be a structured way of governing a product".

To monitor quality, PTC has stage gates, where every product is evaluated. The corridors of the facility depict the principles and the working environment there.

A wall reads, "TEAM: Together Everyone Achieves More".

Perhaps, that's the starting point of the company's recent achievement-the first drug discovered in India.

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First Published: Aug 21 2013 | 12:47 AM IST

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