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Aseptic Processing and Cleanroom Technology

The cleanroom technology market is a growing segment of the manufacturing industry that is expected to expand from a value of $3.87bn in 2019 to $5.04bn by 2025. One of the main drivers of this growth is an increase in sterile drug products, such as injectable biologics and ophthalmic formulations. Market data shows that over half of clinical-stage projects are injectables, and programs for eye diseases have doubled in the past five years alone. Robert Lee and Jason Steele at LLS Health – CDMO Division discuss the importance of cleanroom technology being fit for purpose in aseptic processing and how changing R&D pipelines have led to a rise in the number of companies outsourcing their sterile product manufacturing to CDMOs.


‘Aseptic Processing and Cleanroom Technology’

Innovative inhalation therapies and drug delivery are legacies of the COVID-19 pandemic, as pharma and biopharma formulators address growing demands for new healthcare solutions.

Lactose-based dry powder inhaler (DPI) formulations are the most significant form of inhaled treatment for respiratory conditions such as COPD and asthma. Now, they also being used to treat COVID-19, leading to an increase in demand for lactose-based excipients.

Most DPI formulations consist of a micronized active ingredient blended with larger excipient particles, which enhance flow, reduce aggregation and aid in dispersion.

However, the complexity of the formulations required means it can be difficult to understand the impact of individual compounds on the final results.

A multidisciplinary study by DFE Pharma, Hosokawa Micron and Harro Höfliger aims to help manufacturers save time and money in the development process by testing various formulations of magnesium stearate-coated lactose in the blending and filling process.

This ‘magic triangle’ collaboration, linking global expertise, is part of the new global approach shaping new theories and data to address global healthcare needs.

Formulation specialist DFE Pharma provided different qualities and concentrations of fine lactose to powder processing technology manufacturer Hosokawa Micron.

Blending these fine lactose samples without the addition of magnesium stearate establishes baseline levels. Coating different lactose particles with magnesium allows comparison.

The multidisciplinary research extends the findings of previous studies to explore the influence of the different qualities and concentrations of graded powders on the capsule-filling and dosing process.

Its next phase includes the addition of an active ingredient.

By sharing their data-driven insights, the research team is helping generic players stay ahead of the curve and tap into the growing DPI market.

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