Search results for " design" in Articles / App Notes
Article
Supply Chain Challenges for Single-Use Systems
A third challenge is that as suppliers (and the industry) evolve, product ratings, design, or supply chain sources may change, and it is critical to keep users informed. Transparency is a necessity, y…
Article
Optimization of Fed‑Batch Culture Conditions for a mAb‑Producing CHO Cell Line
Process development was supported by a design of experiment (DoE) approach to reduce the number of cultures required to infer valuable information on how certain feed combinations influence culture pe…
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Ensuring Viral Safety of Viral Vaccines and Vectors
EMEA, Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses. CPMP/BWP/268/95, (London, revised 1996).…
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The Challenge of Disruptive Technologies in Bioprocessing
Creating a collaborative partnership to qualify, design, and supply materials for manufacturing can be an effective way to reduce non-core activities, address buffer bottleneck challenges, and focus o…
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Biopharma Seeks Balance
CDER’s Office of Pharmaceutical Quality has established an Emerging Technology Program to “promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.” Biopharma …
Article
CDMOs Driving Emerging Bio/Pharma Success
• Regulatory pathways such as the breakthrough therapy designation enable smaller clinical programs and faster approval times, while the 503(b)2 pathway for new formulations of older products may mea…
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Modern Manufacturing Key to More Effective Vaccines
Modern Manufacturing Key to More Effective Vaccines
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
By Jill Wechsler
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Article
Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
The ÄKTA pilot 600 chromatography system is designed to facilitate sanitization, with the high standards imposed by regulatory authorities for purity of the clinical products in mind. In this stu…
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Preclinical Evaluation of Product Related Impurities and Variants
A full factorial design of experiments (DoE) was performed to evaluate the effect of refold pH and cystine/DTT (15). In this study, levels of monomer, oxidized, and reduced GCSF were taken as product …
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
All templated processes start with a single purification process, but there are things you can do to increase the likelihood that it will translate well into a platform such as designing around the mo…