Biosimilar Development solution center
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Imaging Large Volume Subcutaneous Injections To Inform Clinical Design
1/19/2022
New higher volume, higher viscosity pharmaceutical formulations for subcutaneous injection, alternatives to traditional intravenous treatment, enable chronic disease therapy in alternate settings.
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Training Devices And Patient Education Play A Crucial Role In The Self-Injection Drug Delivery Market
11/8/2021
Understand the role training devices and patient education play with regard to self-injection therapies. Review the evolution of injection devices and prefilled syringes, the benefits of training devices combined with patient education, and an empirical look at patient training.
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Capture Of Histidine-Tagged Molecules Using Biacore His Capture Kit
10/21/2021
Find recommendations for immobilization of histidine-tagged molecules (ligands) by capture to an anti-histidine antibody covalently coupled to a sensor chip surface.
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3 Tips For Purifying His-Tagged Proteins
10/21/2021
Tags simplify purification and enable scientists to use standard protocols while also improving the yield, purity, and solubility of the protein of interest.
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Combining Ambr 15 Cell Culture With Octet Titer Measurements
10/20/2021
This platform is an analytical instrument that can easily be implemented in cell line development labs to facilitate rapid determination of product yield.
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Increase Drug Discovery Productivity, Optimize SPR Data Interpretation
9/17/2021
The need to increase efficiency and productivity has led scientists to develop a machine learning solution that can optimize the way that developers analyze and characterize their early drug candidates.
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3 Successful Strategies For Protecting Your New Biopharma’s IP
9/1/2021
Intellectual property is the lifeblood of new biopharma entities. Patent protection is necessary to secure investment, to build a solid foundation with opportunity for future growth, and to establish viability within a highly competitive landscape. This article addresses key patent-related considerations for startups and small or early-stage players in the life sciences arena.
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B. Cepacia: A Case Study For Determining Objectionableness In Drug Manufacturing
8/9/2021
After introducing the subject of colonization and opportunistic pathogenicity in part 1 of this 2-part series, the authors return to discussing B. cepacia in more depth in this article.
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Objectionableness: How To Know If A Microorganism Poses A Risk In Your Drug Product
8/6/2021
It is important to consider at the beginning of an exploration of species “objectionableness” in microbiological analysis that this idea is unique to our specific corner of the world. If you search for a definition of objectionable organisms in a microbiology reference text, you are unlikely to find one. This article, as part 1 in a 2-part series, meets that need.
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Why Should We Rescue The Legislative Intent Of The BPCIA?
7/28/2021
What happens when regulatory ambiguity displaces sound scientific guidance, deterring the legislative intent of Congress? This is precisely the situation regarding the FDA changing the regulatory rules of the road regarding a biosimilar’s strength versus its potency.