Will Manufacturing Strategy Work for Manufacturing and Drug Product...

Will Manufacturing Strategy Work for Manufacturing and Drug Product Excellence?

By Pharma Tech Outlook | Thursday, October 31, 2019

Pharma and biotech companies in today’s world have faced many years of huge drug discovery as well as development costs. However, it is alluring to think that a comprehensive ‘one size fits all’ manufacturing strategy is the most successful route to take.

FREMONT, CA: Manufacturing approach is rarely the best way to obtain both manufacturing and drug product excellence. To explain the reason, it is vital to have a look at the way towards which the industry is heading today.

About sixty-one drug approvals by U.S. regulators were recorded in 2018. Digging deep into it, a recent article by Forbes highlights that 74 percent of those drug approvals were for smaller organizations, while 60 percent of those had never earlier received a new drug approval.

Meanwhile, drug approvals of Big Pharma dropped to 26 percent in contrast to 35-40 percent ten years earlier. The novel therapies can provide drug companies with significant potential and new opportunities; however, they must, at some times, also realize accelerated development and manufacturing cycle to succeed in the business sector. This requires quick, agile, and reliable processes that, based on the resources available, are either externally or internally assisted.

It has become necessary to build a solid drug development strategy and a contemporary manufacturing strategy, whether it is more the entrenched therapy sector or the field of rare disease. To effectively create this strategy, getting it right for the first time can be decisive. A well-planned manufacturing strategy has to be implemented right from the start when entering the first-in-human phase I trials.

Defining the correct manufacturing strategy is firmly based on the enterprise size and philosophy, along with available potential. Hence, it varies for small, medium, and large-sized enterprises. However, there are a couple of significant factors to consider.

A familiar business model for small pharmaceutical and biotech firms

It is essential for the manufacturing process to be agile as the competition within the industry is increasing day by day. While biologics like antibodies, vaccines, and peptide conjugates are very promising fields of development, the costs associated with research and development (R&D) spending is constantly rising. The outcome is increased pressure to manufacture drugs as proficiently and as slim in the process as possible. It is often challenging for cash-strapped small biotech firms. And, to succeed in aseptic manufacturing, drug companies require extensive experience in present Good Manufacturing (cGMP) along with the approval of the site from regulators.

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Often, there is unavailability of in-house expertise in present cGMP, and the equipment that is needed to perform drug development and manufacturing is expensive. This leads to contracting out some portions of the manufacturing and development work.

More choices to medium-sized companies

Contrastingly, while most mid-sized organizations possess financial resources for realizing more of their drug manufacturing and development in-house, they also realize external cooperation. The earlier years have displayed that most biotech and pharma enterprises are capable of performing successfully by functioning with a handful of expensive compounds and therapies. Similar to their counterparts, they focus their resources in an effective way on R&D and marketing while outsourcing the steps of the other process like aseptic manufacturing for commercial and clinical drug products. Subsequently, they can bundle their efforts on finishing projects and emphasize on meeting the expectations of their shareholders and investors. The coordination with the partners supports their day to day functions and overall market success.

A promising strategy for big pharmaceutical and biotech firms

Most often, a suitable approach for giant drug companies is to keep their options open, remain agile, and not rooted in one, inflexible manufacturing approach. One way of fulfilling this general requirement of high-process control can be accomplished by doing all the manufacturing processes in-house. However, it can also be obtained through the distinct way by means of regular quality and process understanding between partner and sponsor. This needs a partner staying abreast of the latest and emerging regulations. Another ordinary used model is utilizing partners to serve as a second source of production, mostly providing the supply of a drug product to particular areas of the world. Achieving a good equilibrium of producing both in-house and externally helps to secure supply, minimize risks as well as optimize performance and flexibility.

To offer final thoughts on suitable drug manufacturing approaches, it is vital to realize that within the industry, there is the existence of various faceted pathways of cooperation models. Of course, this also depends on the character and size of a pharma and biotech firm. Some enterprises attempt to keep the capital costs at a minimum level, while other firms see strategic value in achieving a robust in-house manufacturing competency. Many organizations regularly keep a check on their core competency areas, followed by the decision on the type of cooperation level they will implement for their future R&D as well as manufacturing activities.

However, according to a report, it is confirmed that solution providers will continue to expand their offering, including staff and capacity, to retain clients as their product upgrades in development.

At the same moment, they are pioneers in manufacturing novel products like gene therapies or antibiotics. At the end of the day, it is the biotech or pharma enterprise itself, which has to look for the best balance in manufacturing and development depending on the parameters outlined earlier. Defining and following this personalized pathway is crucial when navigating a rising competitive and challenging market environment. However, it is certain that the chances of failure are less as well as a rare second chance.

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