Search results for " specification" in Articles / App Notes
Article
Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
One hot article answered two commonly asked questions about in-line buffer preparation, which were “Will our buffers work?” and “How can we be convinced that buffers are made to specification?”
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Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
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Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
This week, the Process Development Forum talks with Günter Jagschies, Strategic Customer Relations Leader, Cytiva, about the biopharmaceutical market in Asia.
The Asian market is most often s…
Article
What's in Your SOP?
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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Article
ADC Development Robust Despite Lackluster Performance
ADC Development Robust Despite Lackluster Performance
Despite the disappointing therapeutic performance of ADCs thus far, the pipeline still boasts promising prospects.
By Feliza…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
The roughness of the 304 stainless coupons was comparable to the 316L stainless-steel specifications for the filling parts. The formulated acid and alkaline cleaning agents as well as the finished pro…
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Patenting Prospects for Cell-Based Therapies
The evidence in the specification showed that infusion of a human patient with 100 mg of an expressly disclosed monoclonal antibody resulted in clearance of lung metastases within 24 hours and regress…
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Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
Article
Unifying Continuous Biomanufacturing Operations
…d if a product can successfully be produced within larger-volume tanks that have different geometric specifications--essentially disappear. Klutz at al. wrote that efforts to achieve equivalency betw…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions at the outset and having the depth of experience and knowledge to understand the consequences of the answers are vital to establishing the right specifications during the de…