European Pharmaceutical Review

JULY 13, 2023

By re-engineering existing approaches that have already shown clinical promise, there is potential to bring further benefit to the patient community in its fight against cancer. Since then, several next-generation antibodies have been engineered with modifications that enable them to better engage with immune cells.

Engineering 86

Engineering Food and Drug Administration Safety Patients 86

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 83

Manufacturing Pharma Food and Drug Administration Safety 83

European Pharmaceutical Review

FEBRUARY 24, 2023

The removal/separation of impurities and ensuring the purity of biologics is essential to the safety and quality of the therapeutic. Not only can impurities lead to adverse effects in patients, but they can also introduce product variability. 1 eg, emicizumab uses this ART-lg platform. eg zenocutuzumab (MLCA-128).

Food and Drug Administration 85

Food and Drug Administration Engineering Specialization Food 85

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline.

Food and Drug Administration 76

Food and Drug Administration Safety Patients Leads 76

European Pharmaceutical Review

FEBRUARY 13, 2023

How CAR T-cell therapy ide-cel works Dr Giralt explained that the CAR T-cell therapy recognises and binds to B-cell maturation antigens (BCMA) on the surface of MM cells, leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells. The engineered cells are grown in large numbers.

Food and Drug Administration 112

Food and Drug Administration Engineering Safety Patients 112

Legacy MEDSearch

SEPTEMBER 11, 2023

Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system. Zeta’s computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement. To learn more, visit: www.zetasurgical.com.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.

Manufacturing 52

Manufacturing Medical Food and Drug Administration Pharmaceutical 52