Search results for " patients"
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
…can help prevent the administration of adventitious virus-contaminated viral vaccines and vectors to patients.
References
1. P.P. Pastoret, Biologicals38 (3) 332–334 (2010).
2. R.L. Gar…
Article
The Challenge of Disruptive Technologies in Bioprocessing
“This is related to the significant values handled in manufacturing requiring avoidance of any risks to that value and to the supply of medicines to patients,” says Jagschies.
For existing proc…
Article
Applying GMPs in Stages of Development
Applying GMPs in Stages of Development
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, …
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Article
3rd BioProcessing Asia Preview: Q&A with John Curling
The 3rd BioProcessing Asia conference will take place November 12-15, 2018 on Langkawi, Malaysia. This week, Bioprocess Development Forum talks with John Curling, Conference Chair, about the upcomin…
Article
Witnessing Major Growth in Next-Generation Antibodies
Including next-gen antibodies in pharma pipelines is considered essential for future success.
By Cynthia A. Challener
Next-generation antibodies are designed to be more specific and are ofte…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…ntitious viral agent contamination and to ensure uninterrupted supply of safe biological products to patients in need.
Product safety and quality by design (QbD)
Traditionally, product safety…
Article
Framing Biopharma Success in 2016
Counterfeit drugs and drug shortages disrupted the delivery of safe, effective therapies to patients. Oversized, inefficient research, development, and manufacturing engines were downsized, or transfe…
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…