Search results for " development" in Articles / App Notes
Article
Understanding Validation and Technical Transfer, Part 3
Initially, development information can be kept in research or laboratory notebooks, but as clinical use becomes likely, formal development reports and initial validation work should be prepared, revie…
Article
Being Thorough When Transferring Technology
…ames Blackwell, president of The Windshire Group, LLC; and John Moscariello, vice-president, process development, and Jeremy Young, director, process transfer, at CMC Biologics Seattle.
The…
Article
Downstream Processing for Cell-Based Therapies
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 directed towar…
Article
DoE Provides Benefits, but Preparation Is Necessary
28-29
Using a design-of-experiment (DoE) approach allows a formulation development scientist to examine the formulation design space in a statistically significant manner from the beginning of ex…
Article
Essentials in Quality Risk Management
…t drug critical quality attributes (CQAs) are defined and maintained from phase to phase during drug development and manufacturing and changes in drug-product formulation, definition, analytical meth…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
…efficacy, and similarity compared to the reference product, says Olaf Stamm, PhD, technical business development director, Biopharmaceutical Testing Solutions, Charles River Laboratories.
Among t…
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
“Investment in employee satisfaction and career development can help keep turnover low and thereby enable continuity in operational excellence,” he adds. A fit-for-purpose facility design leveraging s…
Article
Enhancing Resins Addresses Purification Concerns
The array of vaccine modalities that have been in development to address the COVID-19 pandemic all rely on different viruses or viral parts as part of their composition. Although recombinant vaccines …
Article
The Need for Advanced Process Modeling for New Therapeutic Biologics
The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.
By Feli…
Article
Biopharma Seeks Balance
Maintaining a balance of multiple, sometimes conflicting priorities is no easy task for companies at any development stage.
During the past 30 years that BioPharm International covered the biop…