Search results for " preclinical development; clinical …"
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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 …
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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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Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
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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…
Article
The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies
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Bioanalytical studies are an important aspect of biologic drug development that may necessitate…
Article
Can Vaccine Development Be Safely Accelerated?
Can Vaccine Development Be Safely Accelerated?
Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.
By Cynthia A. Ch…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
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Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
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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…
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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…