Search results for " Phase III"
Article
From Darwin to Recombinant Fc Multimers
Positive data from the clinical Phase II study was presented and the project will now progress into Phase III.
Carlos Bosques from Momenta Pharmaceuticals had a presentation titled IVIg-Inspire…
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Witnessing Major Growth in Next-Generation Antibodies
De Fougerolles expects Ablynx to report results of an on-going Phase III study in the second half of 2017 and be at the approval stage in 2018.
“There are very few limitations when it comes to the…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
It currently has a partnership with vaccine manufacturing company VGXI for clinical trial quantities, and will be selecting a contract manufacturer for the production of Phase III and commercial quant…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
In March 2012, 73 biosimilar mAbs were under development, with 59 at the preclinical stage, five in Phase I or II, and nine in Phase III. At least 20 companies are, for example, developing biosimilars…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
A…
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Climate Change in Outsourcing
…ting in their development capabilities to satisfy post-POC demand for formulation and manufacture of Phase III and commercial requirements.
The differing requirements for pre-POC and post-POC are…
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The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
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Late stage failures of monoclonal antibodies
In this article, the authors showcase some of the monoclonal antibody (mAb) candidates that reached Phase III clinical trials but were discontinued at later stages.
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Maximum Output Starts with Optimized Upstream Processing
By Cynthia A. Challener
Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.
Significant growth in the develo…
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Novavax Reports on Two Vaccine Efficacy Studies
As part of the company’s Phase III clinical trial of NVX-CoV2373 in the United Kingdom, approximately half the 431 participants who received the Seqirus influenza vaccine were also vaccinated with NVX…