Biosimilar White Papers
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Alternatives To In Vivo Assays For Biosafety Testing Of Biologics
3/31/2020
Even as alternative methods such as PCR and NGS have emerged, in vivo tests have stubbornly remained a central part of testing. Here we examine current in vivo methods and explore modern alternatives.
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User Experience For Manual Injection Of 2 mL Viscous Solutions Is Enhanced By A New Prefillable Syringe
9/17/2020
Although subcutaneous administration improves patient compliance and quality of life by enabling at-home injections, as compared to intravenous or intramuscular route, the associated anxiety, pain, discomfort, and the frequency of injections can play a significant role in patient non-adherence with chronic subcutaneous treatments. In order to address these challenges, through reducing the required frequency of subcutaneous injections and increasing injection comfort for novel biotherapeutics, drug delivery systems are needed to enable the administration of large-volume injections and/or high-viscosity drugs. We developed a pre-fillable glass syringe featuring a stacked 8 mm needle with an ultra-thin wall (UTW) cannula technology as a solution.
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Virus Safety For Continuous Processing
9/5/2019
Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.
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Explore Protein Function Using Surface Plasmon Resonance (SPR)
5/20/2021
We’ve collected a few examples of how an academic research group used Biacore™ X100 SPR system in their research to investigate protein-RNA, protein-protein interactions, and how researchers have used SPR to measure antibody specificity. Download the white paper A year of interaction with Biacore™ X100.
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Generating A Quality Attribute Profile For Antibody-Based Biosimilars: Assessing Differences In Fc-Associated Effector Functions
4/13/2021
During biosimilar drug characterization, the use of orthogonal methods is necessary in providing a complete, detailed overview of the molecule being assessed – Surface Plasmon Resonance (SPR) assays allow for the description of an interaction by both kinetics and affinity, and are able to generate a wealth of information per sample assessment. Here, we review the use of the Sensorgram Comparison tool of the Biacore T200 software in two separate case studies, to detail instances where the affinity (KD) measurements and the binding responses did not sufficiently describe the drug substance interaction to the associated ligand.
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Considerations For Upstream Biologic Development
11/12/2019
A biologic candidate's path from DNA to drug-in-vial is long and complex. These considerations might simplify and improve the economics of the process, helping molecules get to market as quickly as possible.
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Accelerate Process Intensification For Viral Vaccine Manufacturing
7/23/2020
This article details an integrated portfolio of technologies to facilitate process intensification of viral-based vaccines including SARS-CoV-2 vaccine candidates.
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How Successful CDMO Collaboration Sets The Foundation For Sterile Injectable Product Success
6/1/2021
In the realm of Sterile Injectables, sponsors come in a variety of sizes and with a range of experience levels. The same is true for CDMOs, and the dynamics of these outsourcing relationships have a huge influence on project success. Explore how a small or medium size biotech or pharma company can benefit from the experience and assistance provided by a CDMO.
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Meeting Diverse Biologic Pipeline Process Development Challenges
9/10/2020
The biopharma manufacturing industry has been evolving at an unmatched pace. Understanding and managing diverse molecule challenges is key to ensuring they reach patients safely and efficiently.
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Standardizing Vein-To-Vein Logistics To Reach More Patients
2/24/2020
Collaboration is key to solving data management and process variability challenges as stakeholders work towards a common goal—getting life-saving treatments to those who need them.