Risky Business: Manufacturing High Potency Drug Products
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.
Conclusion
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.
References
https://pharma-trends.com/2021/04/22/risky-business-manufacturing-high-potency-drug-products/
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