Purity norms drive nanotech in pharma

A big challenge that drug makers face is the high volume of chemicals which are used and then wasted during the manufacturing process

In a shabby lane of Noida’s sector 2, a non-descript building houses the India offices of a clever little company.
 
Arcanely named i3 Nanotec, it has been using nanotechnology for Indian pharmaceutical majors. One of the big challenges that drug makers face is the high volume of chemicals which are used and then wasted during the manufacturing process. A long-standing challenge for the industry worldwide has been to reduce and recover the input chemicals. By recovering the chemicals, the environmental impact is minimised. But it makes business sense, too, since recovering and reusing the expensive chemicals helps slash input costs.

 
Founder and Chief Knowledge Officer Manish Goel has patented a solution based on nanotechnology filters that is able to offer a high degree of chemical reuse from the waste effluent. The chemicals account for 5-20 per cent of the cost of final product. But nanotech based filters are able to separate the chemicals once the manufacturing process is over. This is as difficult as separating milk from water (which is possible using nanotechnology).

Separation is especially important for pharma and biotech companies if the quality of separated chemicals is almost as good as its original state. This allows the company to reuse it repeatedly with minimal wastages.

 
i3 Nanotec uses automation to manage the entire process of solvent and chemical separation because of the complexity of managing strong, flammable chemicals. A large pharmaceuticals manufacturing company which was generating a significant volume (10,000 litres per day) of a spent solvent-water mixture for purification of the drug substance approached Goel to create a solution for reducing the wastage. The pharma company was throwing away the used chemical mixture. Not only it was polluting the ground, but it also had to import the original solvent for every cycle of production.
 
i3 Nanotec’s Nanomaterials used a vapour permeation process to separate water from solvent. It was able to recover more than 99 per cent of the flammable solvent with minimal use of energy while reducing the wastage. Because of the scale of operation, i3 nanotec used an automation based process controlled by a Distributed Control System and an Intelligent Motor Control Center.

The separation plant at the pharma companies factor plant was equipped with sensors and devices for controlling electrical loads and sensing all process variables (flow, temperature, pressure, differential pressure, level and concentration). Remote management of the plant and advance alerts ensured higher safety for workers who didn't have to be exposed to harmful chemicals. In the end, the pharma company could see reusable solvents coming out of the manufacturing process instead of a toxic blend of wasted chemicals.
 
“As drug specifications become more stringent, the purity requirements for raw materials like solvents, catalysts and reagents are turning very onerous,” says Goel. “Use of nanotechnology for molecular separation is helping pharma companies meet the stricter norms across the world.”

 
The rising use of nanotech in the Indian bio-pharma sector is an important development. While liquid separation is important application, nanotech has several uses for the bio-pharma sector. Nanotech is being used for drug discovery as well as to develop drug delivery systems for patients. Nano-medicines are emerging as a category of pharmaceuticals by itself.
 
For the moment, the nanotech is being used in various ways to bring efficiency to the system while reducing costs and wastage. DataBridge Market research says that the size of global nanotechnology market will grow from $7.24 billion in 2017 to over $24 billion in 2025.

 
As the Indian bio-pharma industry competes with global giants, the use of automation and nanotechnology can offer significant advantages.