Search results for " specification" in Articles / App Notes
Article
The Development and Application of a Monoclonal Antibody Purification Platform
At this point, it must meet yield and purity specifications before it is scaled up for the demonstration run, or transferred to the pilot plant. This process is designed to meet the purification needs…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…
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Top Tips for Successful Development of Antibody Chromatography Processes
In this interview, Jakob Liderfelt, Product Manager at Cytiva, discusses main challenges faced during chromatography process development for mAbs and mAb variants such as fragments and bispecific a…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
Cynthia A. Challener
Upstream viral-vector processes can have sig…
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
STEVE
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Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates, shares insight into regulatory require…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
Materials and suppliers are already qualified, and materials specifications are already developed and set. Often, long lead-time items with long expiry dates can also be held in stock, decreasing the …
Article
Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
…e and leachable profiles using BPOG guidelines on single-use components, and bioburden and endotoxin specifications on validated processes to manufacture these concentrates are some of the necessary …
Article
The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies
Yakobchuk Olena/Stock.Adobe.com
Bioanalytical studies are an important aspect of biologic drug development that may necessitate…
Article
Monitoring and Control of Inline Dilution Processes
But if the pH or conductivity goes out of specification, the ratio will not automatically adjust as with inline feedback control.
Accurate blending is also important, according to Gach. He notes…