Formulation of Biologics Including Biopharmaceutical Considerations

A formulator of biologics faces a variety of questions and challenges when turning an active pharmaceutical ingredient (API) into a biopharmaceutical product. Characterization of chemical and physical properties of the protein is logically the first requirement. Then, the proper excipients and conditions to achieve an acceptable shelf-life of the formulated protein are to be selected. Throughout this process, one should consider the specific requirements linked to the desired route of administration, e.g., dosage form, dose, volume, primary container, and so forth. Alternative routes of administration with existing limitations can be considered for technical feasibility and investment return. A new spinout from Harvard University hopes to one day have people with diabetes reach for a bottle of pills instead of the syringe when they need to take their frequent medications.

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