Podcast: HPAPI Manufacturing: Challenges, Solutions & Innovations

Podcast: HPAPI Manufacturing: Challenges, Solutions & Innovations

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Growth in the highly potent active pharmaceutical ingredients segment means there is strong demand for specialist outsourcing solutions for their manufacture. CDMOs don’t just need to have the right equipment and facilities; they also need to convince sponsors that they possess the in-depth knowledge of safety practices and containment technology.

In this CPhI Worldwide podcast with Carlo Aloni, Production and Process Technology Director at Indena, we will look at the various challenges of HPAPI production, the latest innovative technologies and what Indena is currently working towards in this highly promising growth sector.  

Indena SpAIndena is very well known as a leading API contract developer and supplier. Funded in Italy in 1921, the company is privately owned and serving the global markets with its 4 manufacturing plants. The technological offer covers APIs of botanical, fermentation and synthetic origin, with a unique expertise for HPAPIs. Capitalizing on its twenty year experience in handling HPAPIs development and manufacturing at large industrial scale, an additional new kilolab (LK2), designed to handle the production of highly toxic substances endowed with an OEL of 20 ng/m3 (including toxins for ADCs), was opened in 2018; given the market success, it is now undergoing capacity doubling . Additionally, Indena has opened in 2019 a pilot pharmaceutical plant featuring all the technologies available at Indena, to support clinical APIs and small commercial supplies, with a high degree of flexibility. Besides, a multipurpose fermentation suite (20 thousand liter capacity) is available with the possibility to handle toxic compounds. As far as Spray Drying is concerned, Indena has available two SDs working from organic solvents in the presence of excipients (a PSD2 was installed in 2019). A new smaller scale SD for HIPOs (with OEL ? 1 ?g/m3) will be available in 2021. Indena is continuously investing in its CDMO offer.

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