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Handling Hazards

The pharmaceutical industry’s ongoing search for new medicines capable of achieving greater therapeutic activity while also reducing dosage amounts and minimising undesirable side effects has led to an intense research focus on more potent drug molecules. As a result, the number of highly potent active pharmaceutical ingredients (HPAPIs) under development over the past few years has been steadily increasing, with HPAPIs present in around a quarter of medicines in the pharma pipeline (1).

The increasing demand from the oncology sector has been driving this growth, with around 60% of HPAPIs being developed as anticancer agents (1). With HPAPIs increasingly being used to treat chronic diseases such as diabetes and heart disease, this global market is expected to be worth an estimated $34.8 billion by 2025, up from $14.4 billion in 2016, according to figures from Grand View Research (2).

Highly Potent and Challenging

As HPAPIs are able to produce greater pharmacological effects at lower concentrations, smaller amounts of the drug can be administered to patients, potentially leading to fewer side effects as well as causing less damage to healthy tissue surrounding the diseased area. Furthermore, as lower administration frequencies can be used, patient adherence to medication schemes can potentially be improved. However, the greater potency of HPAPIs also presents several additional challenges to developers and manufacturers in terms of their safe handling.

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As a qualified individual for investigational medicinal products and APIs with over 25 years’ experience within the sector, Carla Brandolini is a Senior GMP QA Specialist at Aptuit, responsible for ensuring and overseeing GMP compliance and batch release. She is also an expert in dealing with regulatory authority audits and follow-ups, as well as the management of controlled substances used for clinical and toxicological studies.

With over 20 years’ experience in the pharma industry, Jean-Francois Carniaux is a highly skilled PhD-trained scientist, whose expertise focuses on API analytical and chemistry development programmes, from early development to late clinical phase and commercial manufacture. As Director of API Development and Manufacturing for the Aptuit site in Verona, Italy, he combines technical expertise in chemical development, including solid-state chemistry and scale-up troubleshooting, with a breath of experience in project leadership and management.

As Vice President, Global Head of CMC for Aptuit, Mario Maio blends scientific knowledge with business acumen, leading his team to provide development expertise for all CMC disciplines and cGMP manufacturing. During his 25-year career, he has developed and monitored early- and late-stage formulation projects and provided strategic direction for the implementation of drug delivery systems, translating innovative ideas into products.

Starting his career in 1996 as a quality co-ordinator, Iain Rusling has gathered a wealth of skills and experience working with some of the biggest companies in the industry, leading him to become Vice President of Global Quality Management and EHS at Aptuit. Iain is an expert in quality management processes thanks to his long-standing experience in different cGMP environments, allowing him to drive initiatives, foster continuous improvement and maintain high levels of accountability throughout the entire area of responsibility.
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Carla Brandolini, Jean-Francois Carniaux, Mario Maio and Iain Rusling
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