Search results for " system"
Article
Generate an Automated Purification Protocol in Three Steps Using Predefined Methods
Regardless of the chromatography technique you are using or if you are using a combination of techniques, UNICORN™ software used for ÄKTA™ systems provides years of purification experience built …
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Biopharma Seeks Balance
FDA actively encourages bio/pharma companies to embrace advanced manufacturing processes and incorporate newer technologies for established systems; however, the industry’s conservative approach to ch…
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Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
Sanitization of the system was performed by running the predefined method using 1 M sodium hydroxide (NaOH) as sanitization agent. The results show excellent cleaning efficiency, with a log reduction …
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Applying GMPs in Stages of Development
This procedure, regardless of whether the product you are investigating is biotech or traditional, or new or old, should require the investigator to review various systems and determine whether they w…
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High Throughput Protein Purification at a Glance
Within the Human Protein Atlas project, scientists are using ÄKTA systems to purify up to 180 protein samples per week. Frida Henningson Johnson, Annelie Cajander, and Anne-Sophie Svensson sha…
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Transformative Medicines Challenge FDA and Manufacturers
While systems that edit DNA are hard to reverse, changes from RNA-editing procedures disappear over time, which can be a plus, or a liability, depending on the situation. Although the long-term effect…
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ADC Development Robust Despite Lackluster Performance
An ADC enables the specific delivery of chemotherapeutics to tumors while avoiding systemic exposure to the cytotoxic compound (1).
Because the stable linkers conjugate cytotoxic molecules to t…
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Fusion Proteins Pose Manufacturability Challenges
Roche/Genentech is focused on cytokine fusion proteins, or immunocytokines, which provide targeted delivery of the cytokines into tumor cells to stimulate the local immune system and avoid responses i…
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Witnessing Major Growth in Next-Generation Antibodies
Application bispecific antibodies are also being applied to diseases of the central nervous system with the development of brain-penetrant antibodies.
“Hence, next-generation biotherapeutic techno…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
The problem of copying biologics
Biologic drugs have revolutionized the pharmaceutical industry by attacking disease using the mechanisms of the cell and immune system. These therapies are fragile…