Challenges in running a pharmaceutical formulation business

Abhrasnata Das | Sunday, 06 February 2022

 Abhrasnata Das

Recently, the board of directors of Panacea Biotec Pharma Limited has approved the sale of its domestic business assets, which include its pharmaceutical formulations brands in India and Nepal, as well as related trademarks, copyrights, and other intellectual property, to Mankind Phanna Limited for a transaction value of Rs 1,908 crore.

According to a study, Only 10% of novel therapeutic items that are developed in preclinical formulations make it to market. With the escalating expenses of pharmaceutical research and the need to unleash drug pipeline value, innovative pharmaceutical formulation firms are putting a lot of work into figuring out how to pick viable formulations faster.

A crucial enabler is gaining a thorough grasp of the shape and structure of the drug substance and drug product. Having said that, let's look at some of the ongoing challenges in the pharmaceutical formulation industry in this post.

Shortage of qualified workforce

Experts conclude that the restricted supply of trained labor will continue to have an influence on the pharmaceutical formulation in the coming year and beyond. Although automation may be able to ease some of the difficulties associated with labor shortages, the basic issue will remain. Preparing employees for the STEM (science, technology, engineering, and mathematics) sectors will necessitate more educational investment - and any territory (city, state, or nation) that can meet this challenge will be well-positioned to lead the industry.

Having a competent workforce is one of the most important factors in ensuring a resilient pharmaceutical formulation firm. The pharmaceutical sector, in reality, requires staff with extensive knowledge, expertise, and abilities.

To maintain success, the pharmaceutical industry must boost its investment in highly skilled workers. Workforce training aids in the acquisition of required skills to ensure, develop, and improve their involvement in everyday responsibilities. This will also aid in the filling of skill shortages. The training will primarily focus on how to use technical knowledge in the workplace.

Adoptation of novel technologies

For many pharmaceutical formulation firms, learning to adapt to new and previously unfamiliar technology, such as mRNA, has been a significant hurdle. With the changing market circumstance, firms must not only immediately get acquainted with this technology, but also be fully equipped with the necessary capacity and capabilities, since the demand for manufacturing support for mRNA products is expected to develop.

According to experts, the efficiency and promise of mRNA technologies in the manufacture of vaccines in response to COVID-19 have been established. The capacity to alter mRNA makes it a perfect weapon for combating viruses that change fast, but it also has the potential to be employed in the treatment of a wide range of disorders.

This is evidenced by the fact that, as of July 2021, there were over 70 mRNA therapies in clinical trials throughout the world, with many more in the early stages of research.

Solubility Challenge

Approximately 90% of the compounds currently in the discovery pipeline are water-insoluble. This raises the risk of inadequate bioavailability, which can lead to inefficient medication delivery, ineffective treatment effectiveness, and negative side effects for patients if not addressed.

The bioavailability issue that these novel compounds present might have a significant impact on drug development schedules; thereby limiting the pharmaceutical formulation firms from the timely delivery of life-saving treatments to patients. Furthermore, current market trends toward regionalization and personalization of treatment approaches need speedier, more efficient, and more adaptable solutions.

As a result, continuous pharmaceutical production is now a hot topic in research, necessitating better process controls and a deeper understanding of the process and product.

Supply Chain Complexities

The pharmaceutical formulation industry's supply chain has long been one of the most complicated and disconnected. It begins with the procurement of raw materials from approved vendors, continues with the production and packaging of pharmaceutical goods, and concludes with the distribution of approved drugs to dispensers and customers.

It encompasses all parties engaged in the procurement, manufacture, storage, transportation, and distribution of drugs across the world. According to a recent analysis by CPhI and Baxter, another supply concern for pharma is the growing need for sustainable sourcing.

Companies are laying the groundwork through their procurement policies and practices to ensure a thorough understanding of the supply risk posed by environmental issues such as climate change and antimicrobial resistance (AMR), as well as social issues such as human rights and ethics, and their potential economic consequences.

Sustainable procurement strives to enhance suppliers' ethical, environmental, and social performance, hence reducing negative supply chain consequences. This has the potential to have a big influence on bio/pharmaceutical production.

To Conclude

Pharmaceutical formulation firms will face multifaceted problems, ranging from formulation and delivery issues to skilled labour shortages and compressed schedules. Integration of sophisticated technology is one possible answer to these problems.

However, according to xperts say pharma is speeding up its digital Industry 4.0 transition in order to improve cGMP [current good manufacturing practise] compliance. The temptation to embrace sophisticated information and data technologies across the company will not go away, and the digitalisation trend will have a long-term influence on operational costs and cost-of-goods accounting.

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