Search results for " activity"
Article
Driving Improved Access to Biosimilars
But she notes that is not always true for biopharmaceuticals, for which biological activity is in the third dimension. “With biopharmaceuticals, a great deal depends on how the individual molecule is …
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.
By Feliza Mirasol
…
Article
Science Focus Fuels Successful Process Development for Startups
“We built a GMP facility to manufacture the products entirely in-house, so process development was a fundamental activity for us,” she adds.
In-house or outsource?
The decision to build its ow…
Article
Advances in Engineering of Protein-Based APIs
…unctions such as antibody-dependent cell-mediated cytotoxicity and complement dependent cytotoxicity activity,” she observes. For example, Amgen has developed a stable effector functionless IgG platf…
Article
Scaling Up Novel Therapies
Scaling Up Novel Therapies
Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?
By Agnes S…
Article
Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…
Article
Biopharma Says It Has an Evolution in New Technologies and Processes
This week, the Process Development Forum interviews Rita Peters, editorial director of BioPharm International, about Interphex 2018.
At the 2018 Interphex trade show in New York City in April…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
What's in Your SOP?
This activity might be acceptable on the condition that the purchased SOP is reviewed and the appropriate changes be made to reflect the actual operations of the company who purchased the SOP. Failure…
Article
Patenting Prospects for Cell-Based Therapies
Cell-based therapies are moving medical treatments forward, but intellectual property uncertainties may delay progress.
By Kevin Noonan
Treatment using cell-based therapies is a rapidl…