Search results for " potency"
Article
Evolving demands of process development services
Novel conjugates involving combinations of oligos, peptides, high potency payloads, linkers, and specific carriers are increasing, but the resources required are lagging worldwide.
One of the other…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
New technologies for rapid, in-line assessments of product concentration, potency, and purity are also needed. Meanwhile, new analytical, quality assurance, and regulatory approaches are needed to imp…
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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
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
Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
In recent years, the global biopharma industry has seen a rapidly advancing trend toward biotherapeutics or ‘biologic’ drugs—drugs that are produced from living organisms or contain components of li…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
“Therefore, production strategy is all about preserving the cell phenotype across multiple production steps and scales, meaning that keeping the therapeutic potency (defined individually for every the…
Article
An Analytical Approach to Biosimilar Drug Development
…ctures; the purity and impurities; the post-translational modification, such as glycan profiles; the potency or biological activities; and other functional tests, such as receptor binding.
An…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
…precision, and linearity with the assay, making it useful for establishing comparability, estimating potency and examining stability (17–20). SPR has also shown greater precision and reproducibility …
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
More consistent and reliable production processes are critical for advancing innovative treatments.
By Jill Wechsler
…
Article
Biopharma Seeks Balance
The panelists noted that analytics will be a key element in development and manufacturing phases and new potency assays are needed.
Regulatory authorities also need to get up to speed. The meth…