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Integrating Bioanalytical Automation, Biomarkers, Pharmacogenomics, & Cost-Effective Strategies

Conversations in Drug Development Trends

End-to-end workflow automation, from sample receipt, processing, analysis, and reporting, will likely become an industry standard, making it an essential tool for drug development. Biomarkers are indispensable tools in clinical trials, providing critical insights that enhance the efficiency and precision of drug development.

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The Agency recommended that sponsors follow the requirements under 21 CFR 211.84(d)(2)

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Choosing the Best Bioanalytical Platform for Your Program

Alta Sciences

Efficient Characterization of ADME A critical feature of the bioanalytical platform selected for a drug development program is how well it characterizes the ADME (absorption, distribution, metabolism, excretion) of your molecule of interest. Why Partner With Altasciences for Your Bioanalytical Projects?

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Target-directed cancer: protein-ligand interactions  

Drug Target Review

We support the drug discovery projects of the CCDD with assay development and screening, biophysics, structural biology and recombinant protein production. In 2019 he became Reader in Structural Biology and Cancer Drug Discovery. Although we are an academic centre we work very much like industry.

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The essential role of recombinant phage display antibody libraries

Drug Target Review

In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. Adapted from Harth S et al. (8) 8) under a CC BY-NC-ND 4.0.

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Tech Transfer Tools: The Requirements and Uses of Manufacturing Process Descriptions

The Premier Consulting Blog

The process will be transferred from the development lab to a pilot or small-scale manufacturing facility and, if the program is successful, to a facility for commercial manufacturing. The tool used to transfer the information to the receiving party is called the manufacturing process description (MPD).

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Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

The document has been updated over time to implement advances in understanding cancer and drug development. In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance. For example, the first three editions focused on cytotoxic compounds.