Search results for "regulatory" in Articles / App Notes
Article
Gene Therapies Push Viral Vector Production
Some of the serotypes have been successful preclinical and clinical followed by regulatory approval in both Europe and the United States. “This makes it a popular starting point for gene therapy, alth…
Article
Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug
"Aji Bio-Pharma's drug product experience, infrastructure, and strong regulatory track record were important to this partnership and in the timely supply of this therapeutic."
Source: Ajinomoto Bio…
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Five Reasons for Outsourcing Chromatography Resin Lifetime Studies
Resin lifetime studies are a regulatory requirement for new drug application (NDA) filing. But are running these lengthy and repetitive studies the best use of your process development time? Discove…
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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…
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Tools and Processes for Mature and Emerging Therapies
Budget constraints, uncertainty about unproven technology, and concerns about gaining regulatory approval were some reasons biopharma companies hesitate to adopt new technologies.
Emerging therapi…
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Case Study: Oncolytic Adenovirus Production
Purity of final samples meets regulatory requirements.
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Article
Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
Understanding the Regulatory Environment
Regulatory-focused articles were the most popular 2018 posts on the Process Development Forum, with validation and tech transfer being especially importa…
Article
Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
The ÄKTA pilot 600 chromatography system is designed to facilitate sanitization, with the high standards imposed by regulatory authorities for purity of the clinical products in mind. In this stu…
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Tools and Solutions for Separation of Charged mAb Variants
To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be demonstrated. Biomolecules, however, exhibit high structural complexity …
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Preclinical Evaluation of Product Related Impurities and Variants
There is no consensus among the regulatory agencies on the maximum allowable limit for these species in the final product formulation; hence an evaluation needs to be performed on a case by case basis…