Search results for " drug" in Articles / App Notes
Article
Automating Bioprocesses
… bioprocessing, although it is in its infancy compared to continuous manufacturing of small-molecule drug products. There are several licensed products that use a continuous perfusion process upstrea…
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Formation of protein aggregates and subvisible particles during the manufacturing of drug products are a major concern due to the potential immunogenicity of protein aggregates in patients (17–22). Th…
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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. …
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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…
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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…
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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 …
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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…
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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…
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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 …