Search results for "biopharm" in Articles / App Notes
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The use of disposable equipment in the biopharmaceutical industry is rapidly increasing, as it offers advantages in terms of flexibility, elimination of cleaning procedures, and reduced capital expend…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
Challener, PhD, is a contributing editor to BioPharm International.
Article Details
BioPharm International, Vol. 28, Issue 1
Pages: 36-39
Citation: When referring to this article, plea…
Article
Improving PAT for Biologics
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) approach to pharmaceutical manufacturing is the implementation of process ana…
Article
Biopharma Manufacturers Respond to Ebola Crisis
Oct 1, 2014
By: Jill Wechsler
BioPharm International
Volume 27, Issue 10, pp. 8-9
The development of new treatments to combat the lethal Ebola virus has been slow, stymied by difficulti…
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
Amy Ritter, Scientific Editor at BioPharm International, spoke with Dr. Howard Levine, President and Principal Consultant of BioProcess Technology Consultants, about what these guidelines mean for dev…
Article
Quality by design for biotechnology products—part 1
Therefore, this paper offers guidance and interpretation for implementing QbD for biopharmaceuticals, from early-phase development steps such as identifying critical quality attributes and setting spe…
Article
Sterilization Trends for Single-Use Consumables
As the biopharmaceutical market continues to expand and reliance on single-use manufacturing rises, demand for SU consumables—bags, containers, filters, tubing, etc.—is also increasing. The value of t…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
…y compared to the reference product, says Olaf Stamm, PhD, technical business development director, Biopharmaceutical Testing Solutions, Charles River Laboratories.
Among these criteria are compa…
Article
Top challenges in recombinant protein purification process development
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Transcript
Jeanne Linke Northrop: Hello, I'm Jeanne Linke Northrop with BioPharm International, and I'm joined today by Emma Lind, Global Product Manager for resins and techno…
Article
Digitalization: The Route to Biopharma 4.0
Biopharmaceutical manufacturers are also giving significant attention to automation and data analytics so as to embrace Industry 4.0. The ultimate objective is to make an automated smart factory, wher…