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Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.
This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.
Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.
July 02, 2013
A screening method aligned with USP 1660 guidance predicts glass delamination in primary packaging for parenterals.
Understanding the supply-chain challenge and coupling high-efficiency chromatographic techniques with information-rich detectors are leading to improvements in the management of extractables and leachables in parenteral drugs.
The author presents best practices for extractables and leachables.
GE Healthcare's partnerships with iBio and Brazil's Bio-Manguinhos/Fiocruz for a new plant-based multipurpose biopharmaceutical and vaccine manufacturing facility move plant-based protein production to the next level.
June 28, 2013
The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.
June 26, 2013
Since its inception in 2011, Fujifilm Diosynth Biotechnologies has added capabilities and single-use production capacity for mammalian-derived product manufacturing, upgraded development and pilot-scale microbial laboratories, and installed advanced analytical instrumentation.
The benefits of single-use systems are being realized for downstream unit operations, including aseptic filling.
June 24, 2013
Global program seeks to confirm biosimilarity to support regulatory submissions in the US and EU.
June 20, 2013
A conversation with Kevin Brady of Alkermes about how high potency APIs are changing the way drugs are developed and manufactured in terms of process, equipment and regulations, including a case study that demonstrates the effective scale up or manufacture of a drug with a highly potent API.
June 19, 2013
A screening method predicts delamination in primary packaging.