Drug Development

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Research into Cold Cancers Heating Up

Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

Research into Cold Cancers Heating Up

Development of Gamma-Delta T-Cell Therapies

Activation and expansion are essential for success in both autologous and allogeneic therapies.

Development of Gamma-Delta T-Cell Therapies

QbD for Small-Molecule Continuous Process Development

Continuous manufacturing and a quality-by-design development approach are a natural fit.

QbD for Small-Molecule Continuous Process Development

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Mannitol is the most commonly used bulking agent in freeze-drying formulation design. The benefit of using mannitol is that it crystallizes during freezing and permits drying processes at higher product temperatures, and thus with higher sublimation rates relative to purely amorphous systems (1). Mannitol, however, is known to form different crystalline modifications which compromises reproducibility of product characteristics and storage stability due to phase transformations (2, 3).

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The stability of drugs in solid forms such as powders, tablets and capsules is usually determined very thoroughly by the drug's manufacturer. Based on stability study data, the shelf-life of a drug substance or a drug product is assigned. In addition to dispensing solid dosage forms to patients, pharmacists are frequently asked to compound oral liquid preparations for which the shelf-life or beyond-use date are assigned based on the pharmacist's best judgment - often without the benefit of stability data.

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Conventional influenza vaccines use an egg-based culture and harvest process. This is slow and inflexible compared with emerging cell culture-based approaches that respond rapidly to the influenza virus's inherent ability to 'drift' or, more dangerously, 'shift' - a critical factor that would arise in the event of a pandemic.