Search results for " drug"
Article
Managing Risk in Raw Material Sourcing
In a business environment in which final drug product manufacturers with even the most advanced programs can typically only see two levels deep into their supply chains (3), this represents progress. …
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Because cell-culture media contain a wide variety of materials obtained from various origins and have prolonged contact with the drug substance or final product, they typically rank higher than most o…
Article
Analysis of Glycosylation in Biosimilars
The structures of protein drugs such as monoclonal antibodies are made more complex by post-translational modifications. The most notable of these is glycosylation, where carbohydrate residues are att…
Article
Lessons Learned Accelerate Vaccine Development
Janssen has proven that the product can be stored at customer sites at 2-8 °C, but elected to ship the bulk drug at -60 °C and the formulated product at -20 °C.
Lessons learned
The heightened …
Poster
Modes of controlling charge variant distribution in Mab production
The characteristics of a biological drug, for example, charge variant profile, are determined to a large extent by the upstream expression system and conditions, but can also be influenced by the pu…
Article
Antibody Production in Microbial Hosts
affinity to FcγRIIa than clinical grade drug and displayed enhanced antibody-dependent cellular phagocytoxic activity (42). This work deserves a special mention as FcγRIIa and FcγRIIb have high sequen…
Article
Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD
The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
…range, and covers the requirements for early in vitro and in vivo profiling and formulation of these drug candidates.
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Article
Selecting a Comprehensive Bioburden Reduction Plan
Mittelman and Anicetti are co-chairs of the Parenteral Drug Association task force that developed the bioburden and biofilm technical report titled, PDA Technical Report No. 69, (TR 69) Bioburden and …
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
“By adopting a modular technology approach, we generated a unique capability for biologic drug product filling that for the first time provides flexible and adaptive manufacturing,” asserts Bird. He n…