Search results for "biopharm" in Articles / App Notes
Article
Managing Residual Impurities During Downstream Processing
There is, however, no set of standard assays for the determination of contaminants such as HCPs during manufacturing because each biopharmaceutical process is unique and results in unique impurities; …
Article
Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
Article
Fusion Proteins Pose Manufacturability Challenges
…ines and a longer half-life,” explains Steven Chamow, a principal with Chamow & Associates, a biopharmaceutical industry consultancy.
Specifically, two or more proteins are joined in one polypept…
Article
Witnessing Major Growth in Next-Generation Antibodies
Including next-gen antibodies in pharma pipelines is considered essential for future success.
By Cynthia A. Challener
Next-generation antibodies are designed to be more specific and are ofte…
Article
Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
By Anurag Rathore, Vijesh Kumar
Among the various downstream processing unit operations that are used for purification of biotech products, chromatography is uniquely capable of providing resolu…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Biopharmaceuticals are produced in cell cultures, and the final product is much more than a DNA sequence. These products are subject to post-translational modifications such as glycosylation, phosphor…
Article
Single-use Bioreactors Have Reached the Big Time
Challener
Single-use bioreactors available from various vendors today are robust and provide the high-performance necessary for commercial manufacturing of biopharmaceuticals. Significant advances…
Article
Reconciling Sensor Communication Gaps
Techniques that quantify some over-arching characteristic come to mind—such as refractive index in the chemical-pharmaceutical world—but the quality attributes for biopharmaceutical molecules are so m…
Article
Evaluating E&L Studies for Single-Use Systems
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biopharmaceutical companies have increased the adoption of single-use systems (SUS) and components (i.e., polyethylene bag…