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Challenges for the pharmaceutical technical development of protein coformulations
Claudia Mueller1, Ulrike Altenburger1, Silke Mohl1
1Late-Stage Pharmaceutical and Process Development, Pharmaceutical Development and Supplies, PTD Biologics Europe (PTDE-P), F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Developing protein coformulations presents unique challenges in stability, manufacturing, and analytics. Careful consideration throughout the pharmaceutical development process is crucial for creating safe and effective combination protein drug products.
Area of Science:
- Pharmaceutical Science
- Biotechnology
- Drug Delivery
Background:
- Coformulation of multiple active substances offers benefits like enhanced efficacy and reduced adverse events.
- While small molecule coformulations are common, protein coformulations are less prevalent due to protein complexity.
Purpose of the Study:
- To review the challenges associated with protein coformulations.
- To highlight key considerations for the pharmaceutical development of these complex products.
Main Methods:
- Literature review focusing on stability, analytics, and manufacturing of protein coformulations.
- Analysis of general considerations for pharmaceutical development.
Main Results:
- Proteins, being large and complex, face significant challenges in maintaining physicochemical integrity during processing, storage, and administration.
- The development of biologics-based coformulations is complex, requiring careful management of formulation, manufacture, and logistics.
Conclusions:
- Protein coformulations introduce substantial challenges in formulation, manufacturing, stability, analytics, storage, transport, and administration.
- A comprehensive approach considering all development stages is necessary for safe and effective protein coformulated products.
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