Regulatory Guidance

Keeping Innovation in Our Hands

How to spur technological advancements in pharma

By Girish Malhotra, President, EPCOT International

Who is responsible for manufacturing technology innovation?

Sometimes the answer to a question exists but is ignored for the sake of convenience. However, it’s good to ask the question again to refresh and reinforce the established answer. We all know the answer to the question, “Who is responsible for the quality and manufacturing process technology innovation for any product?” The answer is clear: the manufacturer and process developer who is the creator of the product. At times, however, regulations and equipment manufacturers get in the way of this process. In particular, too much emphasis has been put on what kinds of processes manufacturers use — instead of whether or not that process fosters useful innovation.

The Role of Regulators

Regulators have to create an environment that fosters innovation, rather than suggesting it.

The primary task of the regulators is to assure that a high-quality product is available independent of type of manufacturing (batch or continuous) process. Regulators have established cGMP practice guidelines to ensure that this happens on a consistent basis.

But although they have the obligation to approve the manufacturing process and the final product — that doesn’t mean they should endorse a type of manufacturing method. Instead, the process selection and quality assurance are the responsibility of the manufacturing company.

There has been a lot of hype about continuous manufacturing and the idea that this could lower production costs. This could happen if the process meets the product demand and operating criterion needed for the product. But each continuous process design and equipment configuration is product specific. Unlike batch processes that can be used to make many products with the same equipment, continuous process design cannot be used for differing products unless the chemical synthesis and formulation needs are nearly the same.

I equate such regulatory suggestions to telling a master chef how to slice and dice onions who practices the art to perfection every day. Although continuous manufacturing has many benefits, we are still a long way from it becoming a financially feasible in the world of pharmaceuticals.

Making Innovation Routine

There are many factors that take away a company’s incentive to innovate manufacturing technologies, especially the short patent life of new drugs and long regulatory approval times. Many companies also believe in and practice well-known and best processes to manufacture their products — but don’t always have the opportunities to improves those processes.

CMOs, CDMOs and equipment manufacturers have a significant role in manufacturing technology and method innovation. However, the adoption of new technology has to be financially justified.

Therefore, regulators have to create an environment that fosters innovation — rather than suggesting it. One of the ways that could happen is by shortening the approval time for new drugs to three months. This will give companies the freedom and the incentive to innovate and compete on a cost and quality basis.

Companies are often lost in an excess of regulatory guidance and directives that are a distraction. Often, the company’s approach is only to meet regulations, which slows down process advancements. If the costs associated with dealing with regulators could be lowered, companies would have more time to focus on how to better improve and innovate their manufacturing processes.

Regulators will resist giving companies the freedom that would come with short approval times. They still have the ultimate control to shut down a facility if quality deviations exist and cGMP practices are not followed. Plus, the loss of profits alone is incentive to maintain quality and follow good manufacturing practices.

Hopefully, if regulators are listening in the next few years, they will create an innovative manufacturing environment by shortening approval times to three months. That way, commercial and financial considerations can dictate innovations — regardless of the manufacturing process being used.

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