Search results for " preparative"
Article
Preparing for the Future Visions and Insights for Biomanufacturing
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The biopharmaceutical industry has a reputation of being averse to change. Yet, new market dynamics, such as growing competition from biosimilars and niche drugs targe…
Article
Efficient and Scalable Buffer Preparation
This article describes how to ensure a scalable process for buffer management from process development to manufacturing with inline conditioning (IC). It also explains how Ä…
Article
Prepare for an FDA Bioburden Inspection
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Not sure how to best approach a bioburden problem when an FDA inspection is imminent? Anastasia Lolas, former FDA Biologics License Application (BLA) revi…
Article
Preparing for the Future: Visions and Insights for Biomanufacturing
The biopharmaceutical industry has a reputation of being averse to change. Yet, new market dynamics, such as growing competition from biosimilars and niche drugs targeting smaller patient populations,…
Article
DoE Provides Benefits, but Preparation Is Necessary
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 28-29
Using a design-of-experiment (DoE) approach allows a formulation development scientist t…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
Article
Will My Buffers Work When Using an Inline Conditioning System?
Buffer preparation can be both time and space consuming and can easily become a challenge in biomanufacturing. In-line preparation of buffers from highly concentrated, single-component stock soluti…
Article
Implementing Inline Conditioning to Advance Process Intensification
Buffer preparation is still a highly manual activity that often requires a lot of resources due to the large number and overall volume of buffers. With inline conditioning buffers can be prep…