Search results for " platform" in Articles / App Notes
Article
Reimagining Affordable Biosimilars
Exponential advances in new technologies and computing such as mathematical modeling of pharmacokinetics (PK) and pharmacodynamics (PD), organ-on-a-chip platforms, in-silico algorithms, and transgenic…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
For example, he notes that if a platform drug substance downstream process has shown for different platform molecules that a supplement added during fermentation can be depleted to a satisfactory leve…
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Impurity Testing of Biologic Drug Products
The guideline for all phase appropriate levels would be the International Council for Harmonization (ICH) Q2 (R1) (1), although different technical platforms (e.g., enzyme-linked immunosorbent assay […
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ADC Development Robust Despite Lackluster Performance
The candidate is built on the company’s lead ADC platform, Dolaflexin, which consists of a biodegradable, biocompatible, and water-soluble polymer, called Fleximer, and multiple molecules of the compa…
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Improvements in Protein A Chromatography
The Protein A step is platformable so that the same buffers and conditions can be used for many different clinical antibody candidates. This allows for fast step development. Alternative technologies …
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Witnessing Major Growth in Next-Generation Antibodies
“Novel antibody platforms have primarily been applied to cancers because immunogenicity and potential unforeseen clinical effects that might be better tolerated for cancer treatment than for chronic t…
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Reconciling Sensor Communication Gaps
The desirability of platform purification, best exemplified in monoclonal antibody (mAb) downstream processing, simultaneously creates and reduces the need for extensive downstream monitoring. Platfor…
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Generating a Fully Processed Antibody
…d by Chinese hamster ovary (CHO) cells, and more recently, numerous different multispecific antibody platforms. Each of these classes of molecules requires multiple proteins to be expressed at differ…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
…ell as the operational aspects of combining process hardware, single-use consumables, and automation platforms.
Overall, there are four sets of requirements to consider: product(s) to be made, pr…
Article
Continuous Processing for the Production of Biopharmaceuticals
Effectively, the configuration can significantly contribute to the development of an integrated continuous bioprocessing platform for bacterial recombinant proteins.
Figure 1: (a) Illustration of …