Search results for " monoclonality" in Articles / App Notes
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
Article
A Continuous Confidence Boost
Continuous processing of monoclonal antibodies (mAb) could offer a number of advantages, but regulatory uncertainty and upfront investment remain sticking points.
In this case study, Shanghai Henli…
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
By Agnes Shanley
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Article
New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges
Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…
Article
Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
Article
2019 HTPD Conference Abstract Submissions Are Coming Up: What Happened Last Time?
The 5th international conference devoted to high-throughput process development (HTPD) and smart PD, will take place November 4–7, 2019 in Porto, Portugal.
HTPD 2019 will cover process…
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Intensified Chromatography Strategies
The blockbuster drug era is over and drug manufacturers are now striving for a more diversified portfolio by targeting a greater number of monoclonal antibody (mAb) products at lower production volu…
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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
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Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…