Search results for " download"
Article
Trends in BioPharma Approvals in 2013
In 2013, 20 products containing new biopharmaceutical molecular entities (defined herein as recombinant proteins, monoclonal antibody or biosynthesized nucleic acid-based products) were approved in t…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
Bioprocess filter selection guide
Filter selection can be a daunting task, and with so many options available, it’s hard to know what is right for your process. This new bioprocess filtration selection guide can help get you o…
Article
High-concentration monoclonal antibody drugs: manufacturing challenges
The growth in the formulation of drugs suitable for delivery by subcutaneous (Sub-C) injection highlights manufacturing challenges associated with the higher concentration of active ingredient…
Article
A risk based approach to sterile filtration
Drug quality cannot be assured only by finished-product testing. Process validation is required to establish scientific evidence that a process is capable of delivering an effective and safe …
Article
Host cell protein quantitation using ELISA
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step c…
Article
eBook: Purification of Antibody Therapeutics - Approach for Diversified Pipeline
Antibody therapeutics are the largest class of biotherapeutics. Over the years, development beyond traditional monoclonal antibodies (mAbs) has increased. Today, we see multispecific and bispe…
Article
New hydrophobic interaction chromatography (HIC) handbook
Hydrophobic interaction chromatography (HIC) separates biomolecules under mild conditions according to differences in molecular hydrophobicity. HIC is often used as a next step to purify prote…
Article
Quality by design in biotherapeutics purification white paper
Learn how understanding and addressing variability sources can help you develop robust chromatography processes. The principles and methodologies of biopharmaceutical manufacturing are well …
Article
Typical Purification Protocols to Obtain the Right Purity and Yield
Download the guide >>
So how do you best combine chromatography techniques to obtain the right purity and yield of your protein? Our free digital guide helps you effectively combine the main chro…