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Takeda will discontinue Gammagard S/D by December 2027, transitioning to the new low IgA formulation. Takeda has informed the FDA that the manufacturing of Gammagard S/D will cease in December 2027.
This can be attributed to the fact that encapsulation technology allows tailored release of the active compounds, enabling sustained or targeted delivery to specific sites in the body. Further, majority of the technologies in the subcutaneous biologics industry are working on encapsulation principle.
As Part of Europe’s leading Injectable conference series, we will assess innovations in drug product formulation and biologics, new technologies in device design and the use of long-release injectable compounds. The injectable drug delivery market is expected to rise at a compound annual growth rate of 12.9% Device Engineering.
4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). These new operating models can help enable and accelerate the efforts of Pharma 4.0™
The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.
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