Search results for " biologic" in Articles / App Notes
Article
Mapping a Route for Cell and Gene Therapy Process Development
These products are highly complex and often involve production methods that, while in some ways are similar to those used in biologics and vaccine manufacturing, in many ways are quite different.
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Driving Improved Access to Biosimilars
But she notes that is not always true for biopharmaceuticals, for which biological activity is in the third dimension. “With biopharmaceuticals, a great deal depends on how the individual molecule is …
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Methods Accelerate Biosimilar Analysis
…zation of primary structure and both enzymatic and non-enzymatic post translational modifications of biologics. Until recently, higher-order structures, including secondary and tertiary structures, w…
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Making the Move to Continuous Chromatography
…ccording to Michelle Najera, senior development scientist for downstream product development for AGC Biologics. “The load phase can be split into two columns in series as well, allowing more product …
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Industry Adoption of Single-Use Systems Remains Low
The ability to manufacture a comparable amount of biologic product due to process optimization means a smaller facility with single-use equipment can be a preferable solution to a traditional stainles…
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Reducing Cross-Contamination Risks in Process Chromatography
Today, single-use bioreactors are widely used for biologic drug manufacturing, and downstream disposable technologies for commercial-scale production operations are being introduced and increasingly a…
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Patenting Prospects for Cell-Based Therapies
Indeed, it may be the case that regulatory exclusivity—analogous to the 12-year market exclusivities for biologic drugs provided by the Biologics Price Competition and Innovation Act (BPCIA)—will be m…
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Impact of Media Components on CQAs of Monoclonal Antibodies
These modifications can profoundly affect protein quality relevant to clinical efficacy, safety, and half-life of biologics (1). Mammalian cells meet these criteria quite efficiently by virtue of thei…
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Establishing Acceptance Criteria for Analytical Methods
• FDA, Analytical Procedures and Methods Validation for Drugs and Biologics (6): “An analytical procedure is developed to test a defined characteristic of the drug substance or drug product against es…
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Real Time Continuous Microbiological Monitoring
…ough an appropriate detection cell, resulting in the real-time detection of both inert particles and biologics such as bacteria, yeasts, and molds. Fluorescent (or fluorophore) dyes (molecules) can a…