Search results for " development"

Article Science Focus Fuels Successful Process Development for Startups
They lack access to revenue streams from existing drug sales to fund their process development efforts, so money must be raised, which requires convincing investors that the ideas they are developing …

Article Challenges in Analytical Method Development and Validation
The development and validation of analytical methods is crucial in drug development. While the biopharmaceutical industry has had success in reducing risk by incorporating analytical platform technolo…

Article ADC Development Robust Despite Lackluster Performance
This has not stopped ADC developers, though, and the biopharmaceutical pipeline is populated with ADC candidates under development.  The promise of conjugation ADCs are part of a relatively new c…

Article Lessons Learned Accelerate Vaccine Development
Challener Vaccine development is a complicated process that can take many years to bear fruit. More complicated diseases such as AIDS and malaria have proven particularly challenging in this respe…

Article Current and Future Trends in Biosimilar Development: A Conversation with GE's Gunter Jagschies
Process Development: Do you see that the introduction of the biosimilars class has changed the industry in any way? Yes, in several ways. First, innovation is being fostered and the competition ha…

Article 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. Challener  MONGKOLCHON - STOCK.ADOBE.COM …

Article Platform Approach Speeds Process Development
At Boehringer Ingelheim (BI), advances have enabled higher performance benchmarks in time and resources for process development with stringent product quality requirements. An expression platform has …

Article Tackling Analytical Method Development for ADCs
Their composition--a biologic linked to a small-molecule cytotoxic, which enables targeted delivery--also creates challenges for analytical method development, both for characterization and lot releas…

Article Mapping a Route for Cell and Gene Therapy Process Development
These factors make process development and validation for cell and gene therapies a challenging and highly critical task. Scaling differences Depending on the application (i.e., autologous vs.…

Article Applying GMPs in Stages of Development
We have clients with products in various stages of development that are using multiple contracts with multiple services providers for various stages of the manufacturing process. I always struggle wit…

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