April 29th 2025
The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
Discussing Proper Analysis of HCPs in Biomanufacturing (AAPS PharmSci 360)
October 24th 2024The importance of proper analysis of HCPs in the biomanufacturing process was discussed by Shawn Li, principal scientist at Merck & Co., known as MSD outside the Unites States and Canada, at AAPS PharmSci 360.
Strategic Changes to a Legacy Cleaning Approach Result in a More Sustainable Process
October 11th 2024In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.
Cell and Gene Therapy Production Facilities
September 26th 2024In this episode of the Ask the Expert video series, Peter Walters, Fellow of Advanced Therapies at CRB Group, discusses factors to be considered in constructing a new facility for cell and gene therapy production as well as using an existing facility to expand cell and gene therapy pipelines.
Oral Solid Development and GMP Pilot-Scale Suite Enhancements Part of New Recipharm Investment
September 17th 2024The company said this new commitment to its facility in Germany goes hand in hand with its recently announced ReciPredict, an initiative intended to streamline the product development cycle.
PDA/FDA Joint Regulatory Conference: Product Quality Risk in Aging Facilities
September 11th 2024During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R. Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products.
PDA/FDA Joint Regulatory Conference: Proactive CAPA
September 9th 2024CDER’s Jonathan Chapman, senior policy advisor, and Takeda’s Paulien Groll, head of Compliance Excellence, discussed how companies can be proactive with their CAPA strategies instead of reactive, at the 2024 PDA/FDA Joint Regulatory Conference.