Search results for " clinical development"
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Over the past several decades, numerous recombinant proteins have been approved as therapeutic drugs by regulatory authorities, and many more are currently undergoing clinical development (1). Chinese…
Article
Bispecific Antibodies are Moving from Research to Clinical Development
With recent approvals of bispecific antibodies, these complex molecules are fast moving out of the research box and into clinical pipelines.
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Webcast
The GMP of AAV: Purification for Clinical Production
What should you consider when developing a purification process for adeno-associated viruses (AAV)? We’ll share some insights on that topic. And we’ll discuss ways to overcome the key challenges in …
Article
The GMP of AAV: Purification for Clinical Production
Watch this presentation to learn about the key considerations when developing a purification process for adeno-associated viruses (AAV).
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Article
Science Focus Fuels Successful Process Development for Startups
Getting the science right helps biopharma startups overcome development and commercialization challenges.
By Cynthia A. Challener
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Pr…
Article
ADC Development Robust Despite Lackluster Performance
Some examples of ADCs in clinical development include candidates from Seattle Genetics, Immunomedics, and Roche. In addition, companies such as Mersana Therapeutics and Oncomatryx are using different …
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
Addressing the Challenges in Downstream Processing Today and Tomorrow
The standardization of cellular expression systems, bioreactor conditions, purification processes, manufacturing hardware, and disposables has resulted in faster clinical development and lower costs. …
Article
Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
Article
Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches.
By Cynthia A. Challener
For a vaccine to be effective, the components of the disease o…