Time to embrace a new production process

10 October 2017



Moving from batch to novel production is no easy task. The same goes for building bridges between manufacturing processes, as well as the role and process of analytical technology. Continuous manufacturing could be the solution, but many pharmaceutical experts have met this notion with resistance. Salvatore Mascia, founder and CEO of CONTINUUS Pharmaceuticals, explains how this method can increase quality assurance and efficiency.


Using partnerships and collaborative idea hubs are imperative for a healthy business mindset. Surely pharmaceutical experts cannot be going wrong if they allow their ideas to be built upon by the sector’s best and brightest?

Novartis employed this concept when teaming up with Massachusetts Institute of Technology (MIT), which sits among the world’s most prestigious science research universities. The Novartis-MIT Center for Continuous Manufacturing is a ten-year-old research collaboration that functions as an umbrella organisation for small research labs and start-ups that dedicate their time to progressing pharmaceutical production. CONTINUUS Pharmaceuticals, which is a Boston-based start-up and spin-off of the centre, improves manufacturing quality in the pharmaceutical sector and is a strong advocate of integrated continuous manufacturing (ICM).

The centre is focusing on areas where pharmaceuticals falls behind other industries that have experienced disruptive innovation, which refers to new markets that target different demographics with updated products that change the course of the market. A team of researchers is hoping to accelerate the introduction of new drugs by using efficient production processes. This method requires smaller production facilities with lower building and capital costs, which means that the team must also minimise waste, energy consumption and the use of raw materials across the industry. The organisation’s other goals include monitoring drug quality on a continuous basis, and enhancing process reliability and flexibility in accordance with the market’s needs.

The centre originally designed a prototype system to demonstrate how pharmaceuticals can be integrated and produced continuously by using automated controls instead of traditional batch production. This model created a 24-hour continuous manufacturing line and illustrated that raw materials can be transformed into finished tablets without interruption.

This means that active pharmaceutical ingredients (API) can be synthesised at the same location, without the need for isolation. These processes may not be radically different, but they do enable drugs to reach patients much faster and at a reduced cost, while achieving consistent high quality.

As part of a new breed in pharmaceuticals, Mascia’s ultimate goal is to find another way to produce and research new drugs.

A new beginning

Trained pharmacist Salvatore Mascia is one of the centre’s success stories. As the founder of CONTINUUS, he dedicates his time to improving efficiency and quality. He has extensive experience in continuous manufacturing and his career blossomed following a series of industry-led projects that focused on finding the most efficient ways to produce drugs. Mascia joined Novartis-MIT in 2008, where he worked on end-to-end projects that centred on modernising pharmaceutical production. CONTINUUS now has 14 employees who specialise in developing the continuous manufacturing process. They also build alliances with others working in the industry, particularly regulatory bodies; securing $20 million in contracts was a major achievement for the team.

Mascia’s ultimate goal is to find another way to produce and research new drugs. In addition to this, he aims to improve industry-wide business practices as a means of reducing costs and lead times, and getting better results for patients.

The cost of transferring a drug from the lab to a pharmacy’s shelf is shocking: a whopping $360 million – which is spread out over 12 years – is the estimated cost of developing a new drug and moving it from the lab to patients.

With this figure in mind, Mascia concentrates on increasing productivity and profitability in pharmaceutical manufacturing. He has four goals, with the first focusing on upping quality. FDA currently provides contracts to build systems in a lab setting, where it monitors quality and makes decisions about future guidelines.

The second goal concerns reducing manufacturing costs. “We want to provide affordable pharmaceuticals to patients,” Mascia says. Keeping costs down is vital as the pharmaceutical sector faces pressure to do more with less; manufacturers often come across slim profit margins, and the price of healthcare and prescriptions is constantly under review in the US.

By implementing ICM, Mascia aims to reduce the cost of producing medicines by up to 50%. This will not only result in higher quality, but also a reduction in lead times by up to 90% from the industry standard.

The third, and perhaps most important goal, is saving time. Continuous manufacturing is shaped around the lean principle (promoting using fewer resources and increasing client value by addressing ongoing production issues to move away from using batch number processes) and other techniques that involve looking at problems in the manufacturing process. “We want to get to a place where it’s possible to produce pharmaceuticals in nine months, with the idea being that clients can make as many products as they need for a specific order, rather than a specified batch number,” he states.

Mascia’s fourth and final objective is to simply embrace new technology, particularly with the development of small molecule pharmaceutical products. The team at CONTINUUS is creating a chain to design reactors and run chemical reaction experiments. They are also working on separating technology for fillers and membranes, enabling development to run continuously, with more continuous filtration, and the use of polymers in tablet and nanofibre forms.

“We are trying to avoid the challenges that come with dry powders,” says Mascia. In order to show that contiguous manufacturing results in continuous ideas, experts look at the potential problems that lie ahead and avoid obvious pitfalls in the production process. However, with a much needed shift comes no downtime and an emphasis that all ideas must be geared towards continuous production. Mascia states that having a better relationship with vendors speeds up production and creates a much tighter schedule. These partnerships play a key role in anticipating changing demands in the process. Mascia adds that his team are building a new control system that will use realtime changes to reduce problems and contamination throughout production lines.

Over the past two years, the company’s ideas have moved from theoretical, to in practise. “By the end of 2017, we will have a new endto- end system constructed,” says Mascia.

But the industry is hesitant. It lacks information about continuous manufacturing, and there are plenty of minds to try and persuade.

“The main structure favoured by the industry is batch production,” Mascia continues. “We want to facilitate and educate the industry, but there is a lot of resistance – especially as many see it as being too much change.” The century-old production technique that is used by most in the industry is only effective to a point.

The trepidation that is felt by the sector is understandable; many are looking to rip up the guidebook on how the pharmaceutical industry has worked for decades. But what benefits will the industry experience from these changes, and what would Mascia say to individuals that remain unconvinced by continuous manufacturing?

“We need to be faster,” says Mascia, meaning the industry as a whole, and how it responds to trends and to problems. Immediate action is needed. “We need different types of pharmaceuticals that cater to different populations worldwide.”

It currently takes several years to get a drug to market and most big pharmaceutical production lines are incompatible with the changing consumer needs.

The industry’s next move

It is predicted that the sector will start to implement these developments. “At the moment, there is a discrepancy between science, development and actual manufacturing,” states Mascia.

New technology is needed to speed up production in order to meet the demands of a booming population that has more chronic illnesses. According to a 2016 paper, the pharmaceutical manufacturing industry wastes up to $50 billion a year on inefficient processes. Raw materials, such as APIs, are produced at separate facilities around the world, adding to the inefficiency of batch manufacturing.

ICM’s processes are the sector’s future, but getting the industry to endorse this method is sure to be a bumpy ride.

Salvatore Mascia, CEO of CONTINUUS Pharmaceuticals, specialses in revolutionising drug production. He was previously the strategic project manager at the Novartis- MIT Center for Continuous Manufacturing.


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