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This latest newsletter provides an overview of recent activities at Nanopharm as well as an interview with Dr Shaban, Head of Pharmaceutical Development.
Nanopharm has been at the forefront of innovation in the field of orally inhaled and nasal drug products (OINDPs). This year, the FDA issued new and revised draft product-specific guidances (PSGs) that strongly support alternative bioequivalence (BE) methods, reducing the need for clinical endpoint studies in generic drug development. This milestone is a testament to Nanopharm’s decade-long collaboration with the FDA, leveraging in vitro and in silico tools to streamline the approval process for generic inhaled drugs.
Nanopharm’s expertise in spray-drying technology is pivotal for the formulation of biologics as dry powders for nasal inhalation. This method offers significant advantages, including enhanced stability and improved bioavailability. The company’s advanced particle engineering ensures that the spray-drying process meets the critical quality target product profile (qTPP) requirements, addressing key risk factors such as thermal degradation and physical stability.
Celebrating 21 years of innovation, Nanopharm reflects on its journey from a consultancy to a leading contract research organization (CRO). Founded by Professor Rob Price, the company has grown significantly, driven by its unique blend of academic-led consultancy and fee-for-service research and development. This approach has positioned Nanopharm as a leader in early-phase respiratory drug development and manufacturing.
Nanopharm’s collaboration with the FDA has been instrumental in reducing the clinical burden of generic inhaled drug approval. The recent FDA guidances mark a significant shift, allowing for alternative BE approaches that combine in vitro, pharmacokinetic (PK), and in silico methods. This change is expected to unlock the potential of generic OINDPs, making the approval process more efficient and less costly.
Dr. Kais Shaban, Head of Pharmaceutical Development at Nanopharm, highlights the company’s commitment to innovation and growth. With a focus on inhalable dosage forms, Nanopharm continues to expand its capabilities, offering comprehensive support from preclinical to clinical development. The company’s investment in GMP facilities and specialist teams ensures that it remains at the cutting edge of inhalation science.
Nanopharm’s dedication to advancing nasal drug delivery and inhalation therapies is evident in its continuous efforts to improve and innovate. By staying at the forefront of regulatory changes and technological advancements, Nanopharm is well-positioned to support the development of safe and effective OINDPs.
