Search results for "regulatory"
Article
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…
Article
Driving Change in Biomanufacturing
The new technology must be fully understood, all regulatory requirements fulfilled, the quality of the product output secured, and a thorough risk mitigation conducted.
The large buffer volumes …
Article
The New World of Biopharmaceutical Manufacturing
Part of this persistent concern for L&E issues is the increased use of disposables, which, in turn, has increased awareness of the uncertainties regarding related regulatory issues.
Pora …
Article
N-Glycan Analysis of Biotherapeutic Proteins
Future directions in N-glycan analysis
As glycosylation is a frequently monitored CQA of biotherapeutics, there will likely be increasing regulatory pressure to control processes for better …
Article
Unifying Continuous Biomanufacturing Operations
The researchers wrote, “The enhancement of product quality compared to fed-batch is indeed the most relevant one in a regulatory perspective. The stable operation at steady state and the short residen…
Poster
Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development
…gs, is committed to provide the manufacturing of highquality products and processes that meet regulatory and technical requirements in all countries where it operates, using cutting edge single-use…
Article
Downstream Processing for Cell-Based Therapies
As volumes and cell densities increase upstream, and regulatory requirements for target product profiles become more stringent, the need for efficient, highly specific, scalable DSP techniques grows. …
Article
HTPD: Optimizing a mAb Chromatography Polishing Step
In addition, steadily increasing demands from regulatory authorities for better understanding and control of manufacturing processes put even more pressure on development work. High-throughput process…
Poster
FlexFactory™ Automation
To enable compliance with regulatory requirements, FlexFactory Automation is designed according to GAMP™ 5 guidelines (ISPE).
Article
The Tide Stays High
US election impacts
Clearly, general economic sentiment since the November 2016 presidential election has been positive, with an expectation that the regulatory environment will be less restrictiv…