As the pharmaceutical industry gradually moves towards innovative therapies with customised and patient-specific treatments, manufacturers now are that specialize in smaller batch sizes of more complex and potent compounds while also ensuring top quality standards. Significant investment in research with a clear shift towards specialty drug products, especially oncology, has been a very growing area of interest for global pharmaceutical players in recent years. As per reports, approximately a quarter of latest chemical entities (NCEs) under development fall into the category of highly potent active pharmaceutical ingredients (HPAPI). Oncology, a serious driver within the growth of HPAPI, shows tremendous growth potential. the worldwide oncology market was valued at USD 16 billion in 2018 and is predicted to grow at a CAGR of 8.7% between 2019 and 2025.

Challenges of containment

An API is taken into account highly potent if it meets one or more of several criteria – primarily if it's biological activity at a dose of 150 μg/kg of weight or below, can bind to specific receptors, is oncogenic, or has the potential to cause mutations and developmental defects. the rise in biological activity and specificity of highly potent drug substances leads to an increased risk of occupational handling of drug substance during product manufacture. A high proportion of latest drugs under development contain HPAPIs. To mitigate the challenges posed by the processing of those drugs will demand significant investment in specialised containment resources. Containment is important to limit the spread of highly active substances, make sure the safety of both employees and therefore the environment, and protect them from exposure to such drug substances. High containment facilities also are a requirement to avoid cross-contamination and protect the products being manufactured.

It is essential for manufacturers to possess or acquire the required technical expertise to be ready to handle and manage the continued operational costs involved in maintaining a posh , contained manufacturing facility that's capable of safely processing multiple highly potent compounds and costs related to waste handling.

Regulatory differences

Pharmaceutical companies are required to figure during a strictly regulated environment. However, currently there's a scarcity of harmonisation of regulations covering HPAPI containment and processing and differ from each other counting on the destination market. The EU follows GMP guidelines for toxicology evaluation, while the european Medicines Agency (EMA) has published guidelines on setting health-based exposure limits to be used in risk identification within the manufacture of various medicinal products in shared facilities. The US Food and medicines Administration, on the opposite hand, recommends a risk-based assessment for cross-contamination. Japan’s regulatory guidance provides requirements in line with the EMA, while it's treated on a case-by-case basis within the remainder of the planet . Although regulations and standards for HPAPIs follow similar themes around containment, cleaning, and handling, the massive number of requirements or the differences among them can pose significant challenges for a manufacturer. The containment technologies and cleanroom capacity required to suits the regulations are expensive, particularly for manufacturers supplying multiple markets.

Continuous production – A viable solution

Continuous production may effectively help within the manufacturing of HPAPI drug products (such as tablets and capsules) and is gradually becoming a trend now. during this manufacturing process, all operations like weighing, mixing, granulation, drying, tabletting and coating are often performed during a closed system within the same room. As compared to batch production, this will reduce the specified production space by up to 70%. Not only can this improve the assembly efficiency but also help reduce the GMP footprint. there's minimal human involvement in continuous production, which needs no manual transfer of products into containers between different process steps. This also greatly minimises risk to the operator or possible cross-contamination with other products.


As drug manufacturers answer the increasing demand for specialised therapies, the amount of highly potent molecules in development has been rising. Therefore, it's incredibly crucial for manufacturers to accumulate the specified knowledge and expertise for the safe processing of such molecules, the differing regulatory requirements around them globally, and most significantly , the security of employees and therefore the environment.


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Pharmaceutical Solutions