Pharmaceutical Technology Europe | Publications | Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and expert industry news.
Lonza will add commercial-scale manufacturing for highly complex HPAPIs and ADC payload linkers at Visp, expanding capacity ...
The companies have been selected to participate in the pilot program to expand domestic pharmaceutical manufacturing and strengthen the US drug supply chain. Documentation reliability across CDMOs, ...
Pharmaceutical Technology | Publications | Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and expert industry news.
FDA cleared Tregzi to improve chronic GVHD-free survival, representing a non-pharmacologic strategy to reduce chronic GVHD while supporting immune reconstitution after allogeneic transplantation.
Pharma Insights - Thought Leadership from Marketers | Sponsored Content | Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and ...
The complexities of tech transfer may be overcome by data-driven approaches, digital tools, and effective communication. Outsourcing in the biopharma and pharma industries is on the rise, driven by ...
FDA will standardize NDCs to a 12-digit (6-4-2) structure, addressing 5-digit labeler-code constraints while creating a ...
BioPhorum, a global forum for biopharmaceutical industry collaboration, has formed a new working group aimed at accelerating innovation across small molecule manufacturing. 1 The Synthetic Molecule ...
The new draft guidance allows for the use of publicly available information and established platform knowledge in regulatory submissions for cell and gene therapies that use genome editing in human ...
Immobilizing the antibodies on a solid-phase support, such as a resin, and carrying out the conjugation of the payload-linker while the antibodies are bound to that support will prevent aggregation at ...
The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products made using advanced manufacturing, batch uniformity, drug product integrity, ...