Commercial Contract Manufacturing of Solid Oral Dosage Forms

Complex manufacturing processes create challenges in terms of costs and supplies.

by Raymond E Peck, CEO of VxP Pharma

Solid oral doses remain a major sector within the pharmaceutical manufacturing industry. As of 2016, solid oral dose forms represented a full 60 percent of pharma contract manufacturing, climbing from $571 million in 2011 to a projected $870 million by 2018, at an impressive compound annual growth rate (CAGR) of 6.3 percent.

As “blockbuster” drugs with broad applications rapidly give way before niche formulations and specialized dosage forms, a growing number of contract manufacturing organizations (CMOs) are investing in specialized plants for the manufacture of solid oral doses. Small-scale, high-value dosage forms, such as pediatric, geriatric, anti-abuse, controlled-release, and taste-masked drugs, are all attracting increasing investment and patent applications.

At the same time, this shift toward more specialized dosage manufacturing brings its own host of unique challenges, for pharmaceutical development firms and CMOs alike. Here are three of the most significant trends in 2017’s solid dose sector, and the hurdles involved in each.

Pharma firms are demanding more flexible, specialized CMO pipelines than ever before.

Pharma firms are demanding more flexible, specialized CMO pipelines than ever before.

Many smaller pharmaceutical firms are designing new drugs with CMO outsourcing in mind.

Earlier in the 2010s, pharma companies frequently designed their formulations without much external feedback, then handed those designs over to CMOs for production. But this approach often created hangups in the production stage, causing CMOs to launch “rescue missions” in order to bring drugs to market on time.

However, over the past few years, a growing number of pharma developers have begun involving their drugs with the active cooperation of outsourcing partners like CMOs. Many are even redesigning products based on problem statements from their partners. In other words, the old client-focused paradigm of “you’re the CMO; find the solution” is rapidly being replaced by two-way collaborative dialogues about development, supply chains, and scaling.

The benefits, for both pharma developers and CMOs, are lower costs, more cost-efficient processes, shorter times to market; and, of course, tidier profits.

Pharma firms are demanding more flexible, specialized CMO pipelines than ever before.

In many ways, this closer collaboration between pharma developers and CMOs is demanded by the shape of today’s market. As broad-based drugs relinquish market share to targeted treatments, many CMOs are seeking to set themselves apart by providing fast, flexible manufacturing solutions for their clients. And to an increasing degree, those solutions are expanding beyond the traditional boundaries of CMO expertise.

These new tailored solutions are oriented not only around more cost-effective production pipelines for complex drugs, but also around quicker and more reliable launches for these products. Many CMOs are acquiring or merging with technology providers, consolidating their capabilities. The space is moving ever more in the direction of integrated concept-to-commercial production, from active pharmaceutical ingredient (API) development, to areas like spray drying, production of innovative dosage forms, and ongoing iteration and improvement of formulations.

Even as the solid dose CMO market continues to grow and prosper, however, ever-evolving demands continue to create complex challenges for global supply chains.

Many CMOs are struggling to balance technical specificity with cost-effectiveness.

Many CMOs are struggling to balance technical specificity with cost-effectiveness.

Many CMOs are struggling to balance technical specificity with cost-effectiveness.

While many CMOs place great emphasis on remaining fast and flexible, the fact is that altering or improving a given process (or transferring it to a new geographical location) creates enormous logistical complexities. Developments like these also place strains on budgets, creating a clear need for innovations in cost-effectiveness, for CMOs that aim to remain competitive over the coming years.

With that end in mind, many CMOs are investing significant resources in improving the robustness of their processes. Driven by the Quality by Design (QbD) paradigm, these forward-thinking organizations are actively seeking to replace the “art” of process engineering with reliable science, in order to stay ahead of the market as new client demands necessitate the rapid development and deployment of new manufacturing pipelines.

The solid dose manufacturing market is defined increasingly by collaboration, flexibility, and high pressure to adapt. As more pharma developers design drugs, from stage one, with the direct intention of outsourcing them to CMOs, it’s natural that CMOs themseles should gain more say in the development pipeline. And as development and production become more integrated, the clear next step for many CMOs is to acquire an even broader range of technical capabilities, in order to deliver the truly end-to-end solutions their clients are looking for.

In addition to being a writer and speaker, Raymond E Peck is the Founder and CEO of VxP Pharma Services and VxP Biologics, both based in Indianapolis Indiana.

About the Author:

Ray Peck