Search results for " efficacy"
Article
Understanding Validation and Technical Transfer, Part 3
Criticality assessments include efficacy, safety, and immunogenicity considerations, and these are used to define CQAs. Process capability is determined through univariate assessment, an understanding…
Article
Understanding Validation and Technical Transfer, Part I
Therefore, the manufacturing and purification processes become critically important in ensuring the “sameness,” quality, efficacy, and safety of these products.
Process validation is documented…
Article
Modern Manufacturing Key to More Effective Vaccines
…ul sticks, is back on the US recommended list after a two-year suspension due to data indicating low efficacy.
Despite the shortcomings of annual flu vaccination, health authorities continue t…
Article
ADC Development Robust Despite Lackluster Performance
Different approaches to building an ADC
Due to past failures in efficacy, safety, and tolerability, other ADC developers are looking deeper into the ADC conundrum to come up with different approac…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
By Jill Wechsler
Amid mounting excitement over remarkable efficacy rates for new genetically modified cellular therapies, regulators and manufacturers alike face continuing challeng…
Article
N-Glycan Analysis of Biotherapeutic Proteins
N-glycans of antibody and antibody-derived biotherapeutics
The influence of N-glycans on the efficacy, stability, half-life, and safety of antibody and antibody-derived biotherapeutics are well-re…
Article
Critical Quality Attributes Challenge Biologics Development
… complex nature of biologics can create additional quality attributes that can affect the safety and efficacy of the biologic (2). Identifying CQAs for biologics can, therefore, be a complicated proc…
Article
Biosimilars: Making the Switch Comes with Challenges
There continues to be widespread scepticism in the region about the quality and safety of biosimilars, and sometimes their efficacy, among physicians and patients. This issue is often because of a lac…
Article
Innovative Therapies Require Modern Manufacturing Systems
FDA’s ability to process drug applications efficiently and to ensure drug safety, efficacy, and quality will continue to draw scrutiny on Capitol Hill, along with drug pricing issues. A broad group of…
Article
Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh
BioPharm Inter…