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Pharmaceutical Manufacturing and Packing Sourcer

Sizing Up

The search for effective therapies for lung diseases – such as asthma and chronic obstructive pulmonary disease (COPD) – has led to a rise in the number of products that require targeted distribution to the lung for efficacy. New concepts increasingly necessitate innovative approaches and are becoming tailored to specific patient populations – the elderly or paediatrics, for example, with more limited pulmonary capacities. Many of these demand preparation and delivery beyond the performance range of more precedented technologies, like pressured metered dose or dry powder inhalers that are based on conventional lactose-blended formulations. There are also handling and product distribution challenges associated with many of the compounds and/or their target patient populations.

There is growing interest in transporting biotherapeutics to the lungs – like vaccines – that might promote enhanced antigen response in the area where the virus first enters the body. These molecules are often challenging to deliver and utilise the most established options, because they are not compatible with reducing sugars and are sensitive to attrition milling. Distributing antibiotics to the lungs in order to aid patients with compromised lung function and increased risk of infection due to poor escalatory clearance – typically those with cystic fibrosis – is also gaining traction. These therapies require the delivery of large doses, often much higher than 5mg of active pharmaceutical ingredient (API) per respiratory event, which is very limited with lactose-blend technologies.

Highly potent APIs are increasingly being used in pulmonary applications for acute inflammation as well as specialised high containment infrastructure, and protocols are needed to handle these at all stages of the product development cycle. Many firms cannot justify the investments required – especially the small to mid-sized speciality companies that hold much of the early stage development pipeline – and therefore must utilise contract development and manufacturing organisations. There are a limited number of such partners with the capability of handling these types of compounds as well as the inhalable product formulation expertise and processing infrastructure, especially with respect to commercial scale production.

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Devon B DuBose is Director of Early Phase Formulation and Process Development at Capsugel’s Bend Research site. His responsibilities include leading multiple teams focused on the development of early phase drug candidates and technology transfer into Bend Research’s current Good Manufacturing Practice facility for clinical development. Devon’s technical focus during his time at Bend Research has been on spray drying formulation and process development for oral and inhalation drug products.
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