Our virtual CPHI Discover event (17th-28th May) is just around the corner, full to the brim with three main content tracks. Here, we explore the major trends and issues surrounding Manufacturing and Outsourcing
Drug production is an ever evolving field with innovation being driven by the need to manufacture more effective therapies in a manner with is both cost and time efficient.
The traditional view is that the pharmaceutical industry is slower to adopt new manufacturing techniques than other sectors because of the need to validate processes with regulators. While this is true to an extent, in recent years drug firms have shown a greater willingness to embrace change .
In part the attitude change reflects growing acceptance of the benefits of newer production and processing methods. Continuous manufacturing – the process of making drugs on a constant basis rather than as specific separate batches – has gained in popularity in the past few years.
Regulatory support for new manufacturing techniques has also encouraged industry to adopt them. Again, continuous manufacturing is a good example; the US Food and Drug Administration has been advocating for the approach for several years .
More recently the United States Pharmacopeia (USP) and pharma start-up Phlow have built a laboratory that will develop test methods and standards for continuous manufacturing .
Hot melt extrusion (HME) is another manufacturing technique that is growing in popularity in the pharmaceutical sector. Originally developed for plastic and food production, HME is used by pharmaceutical firms to make formulations that enhance the solubility of APIs.
Another advantage of HME is that it can be used with a wide range of excipients – making it applicable to the production of a wide range of formulations. It is also straightforward to include analytical technology in HME processes.
Biopharma manufacturing
Analytical techs are also key to the evolution of biopharmaceutical manufacturing. Use of technologies like mass spectrometry has increased as biopharmaceutical companies have sought to increase their understanding of biological systems.
Likewise more drug companies in the large molecule space are using proteomic analysis to characterise the cell lines they used to manufacture protein-based medicines.
More generally the biopharmaceutical industry has embraced process analytical technologies (PAT) to model production processes in keeping with a shift towards quality-by-design (QbD).
Outsourcing
Pharmaceutical industry use of contract manufacturers has been increasing for several decades. Initially, drug companies handed over relatively simple, functional activities like fill-finish to contract manufacturing organisations (CMOs) in an effort to reduce costs and reduce internal capacity.
More recently the dynamic has changed with drug companies seeking contractors that offer a broader range of services or those that are willing to play a more strategic, longer-term role in production.
According to analysis by PwC, demand for contractors offering strategic partnerships is increasing as pharmaceutical companies “shift their focus towards scientific research and pharmaceutical marketing.”
The authors say: “These co-operations can even lead to co-investments, as some pharmaceutical companies help finance specialised development and manufacturing facilities at strategic CDMOs.”
In the small molecule space, areas attracting investment at present include capabilities in the production of high potency APIs and continuous manufacturing.
Demand for CDMOs that can manufacture biopharmaceuticals and cell and gene therapies is also increasing. According to a recent study the global biologics CDMO market, valued at $9.93 billion in 2020, will be worth $18.9 billion by 2026. The authors cite the drug industry’s development of cancer therapies as a major driver.
They also suggest growing ...
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