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Article / Jun 01, 2020

Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules

Drug Development & Delivery, June 2020

Special Feature, from page 63 to 71

 

Hovione: Particle Engineering for Small & Large Molecules

Hovione has strategically decided to explore niche areas that are difficult to tackle and can benefit from its expertise in particle engineering. Examples include the oral delivery of Amorphous Spray Dried Dispersions and the manufacturing of dry powders for inhalation. Historically, Hovione has mainly focused on small molecules and their pre-formulation, by means of particle engineering, to overcome solubility limitations or to render them suitable for inhalation. In recent years, Hovione has experienced some challenges with large-molecule particle engineering, but intends to increase its activity in this area. “The delivery of large molecules is leading us to novel areas of aseptic particle engineering that we will be introducing in our portfolio,” says Teresa Alves, PhD, Senior Director, Science & Technology, Hovione. Dr. Alves adds that there are opportunities to apply lessons learned with small molecules to large molecules. “We see a trend in the increased delivery of biologics by inhalation, particularly dry powder inhalation, including the delivery of peptides, proteins, hormones, DNA, RNA, etc. We are also actively working to process low bioburden biologics to solve difficulties that our clients experience in limited shelf life, high viscosity, and new areas of administration.”

Márcio Temtem, PhD, Site Manager, R&D services, Hovione, explains how the company’s sponsors have benefitted from Hovione’s experience in spray drying. “Spray drying scale up runs with minimum work at scale,” he says. “This is what we call Development by Design. By relying on stasticial and mechanistic models, databases, and scientific know-how, we can save API and time required for CMC process development. We have successfully applied these tools to biologic molecules, namley proteins, antibodies, and fragments of antibodies, and some of these solutions have evolved to commercial manufacturing.”

 

 

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The global inhalation contract development and manufacturing organization (CDMO) market is projected to grow from USD 9.13 billion in 2025 to USD 16.68 billion by 2035, reflecting a compound annual growth rate (CAGR) of 5.7% during the forecast period. This growth is driven by the increasing prevalence of respiratory diseases, advancements in inhalation drug delivery technologies, and the rising demand for outsourced manufacturing services in the pharmaceutical industry. The inhalation CDMO market has emerged as a pivotal segment in the pharmaceutical contract development and manufacturing industry. With a rising demand for inhaled therapies for conditions like asthma, COPD, and cystic fibrosis, companies are increasingly outsourcing drug development and production to specialized partners. Inhalation CDMO services cater to both large pharmaceutical corporations and small biotech firms, offering expertise in formulation, device compatibility, regulatory support, and scale-up manufacturing. This market is gaining traction due to the complexity of inhalation drug delivery, which often requires niche technical capabilities and specialized equipment. Outsourcing to an inhalation CDMO allows drug developers to reduce time-to-market while ensuring quality and compliance with global standards. (...) Top Companies Several players dominate the inhalation CDMO market through technological expertise, global reach, and service portfolio diversity: (...) Hovione – Offers particle engineering and inhalation development, with a focus on dry powder inhalers. (...) These companies are continually investing in facilities, talent, and technology to meet evolving customer needs in the inhalation CDMO market.   Read the full article on Pharmiweb.com        

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