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Making the Grade: The Importance of Using the Correct Excipient Grade in Drug Products
With an ever-growing market driving technological advances, there is always work to be done in drug manufacturing.
Advanced oral dosage forms allow for modulation of controlled- and sustained-release profiles.
Packaging and packaging line innovations are addressing the industry’s growing use of biologics.
What are the lessons gleaned from a product’s E&L lifetime?
There are considerations companies may want to consider before seeking out a service provider.
The Biosimilars Landscape
April 25, 2024
The majority of PMCs/PMRs are proceeding according to schedule.
April 24, 2024
FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors.
Developing freeze-drying processes requires patience and deep product and process understanding.
In a new agreement, Cellares will utilize its Cell Shuttle fully automated cell therapy manufacturing platform to manufacture select CAR-T cell therapies under development by Bristol Myers Squibb.
April 23, 2024
Regulations for mRNA products are evolving as the market for mRNA expands.
April 22, 2024
A panel of experts went over new regulatory requirements for contamination control and gave guidance on implementing a contamination control strategy in cell and gene therapy facilities at INTERPHEX 2024.
Mary Van Gaasbeck, technical services specialist, LS Equipment and Services, at STERIS Life Sciences, notes that automation is key when it comes to effective sterile powder transfer of parenteral drug products.
Andreas Frerix, product management director for Quattroflow at PSG Biotech, discussed the advantages and new challenges SUTs present for pumping systems.
April 19, 2024
New regulations, including those put forth by Annex 1, require many pharmaceutical manufacturers to rethink their facility designs to promote compliance.
Jay Rajagopalan, senior director—Engineering & Product Management for Malema at PSG Biotech, shared insights at on how current industry trends are shaping the development and advancement of sensor technologies.