Assay Development and Information - Drug Discovery Digest

High Throughput Screening (HTS)

Sygnature Discovery

MARCH 14, 2025

High Throughput Screening Workflow The HTS Workflow is tailored to each of our clients requirements, focusing on developing robust assays with a flexible approach, especially in selecting hits to balance false positives and negatives. The process begins with assay development or transfer.

Biochemical Assays

Biochemical Assays Fragment Screening Computational Chemistry Assay Development

New image-based cellular profiling tool peers deeply into metabolic biology

Broad Institute

JUNE 30, 2023

It then extracts features from images of stained cells and creates cellular profiles, categorizing cells based on patterns (often imperceptible to the human eye) that they share with other cells, which directly inform disease biology. That teaches us far more than looking for just a single informative data point.”

Small Molecule

Small Molecule Cell Based Assays Disease Assay Development

Biophysics

Sygnature Discovery

JUNE 17, 2024

Comprehensive Assay Development for Diverse Applications Our team here at Sygnature Discovery, comprised of expert biophysicists, is highly experienced in a variety of target classes and drug modalities. Sygnature Discovery’s Biophysical Assay Development Capabilities: 1. SPR is likely the best technique.

Biophysical Assays

Biophysical Assays Screening Hits Assay Development Fragment Screening

Sygnature Discovery’s hit finding expertise in high demand as cardiac biotech customer, River BioMedics, receives an additional €2M seed investment

Sygnature Discovery

SEPTEMBER 14, 2023

Programs have integrated Sygnature’s novel assay development and hit identification expertise with River BioMedics’ unique, state-of-the-art technology to advance human-predictive in vitro 3D heart models and its deep knowledge of cardiac biology. For further information, visit www.riverbiomedics.com

Small Molecule

Small Molecule Assay Development Disease Drug Research

Choosing the Best Bioanalytical Platform for Your Program

Alta Sciences

AUGUST 21, 2023

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?

Assay Development

Assay Development Pharmacokinetics Drug Development Drugs

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

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

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)

Therapies

Therapies Engineering Production FDA

Target-directed cancer: protein-ligand interactions

Drug Target Review

NOVEMBER 1, 2023

We support the drug discovery projects of the CCDD with assay development and screening, biophysics, structural biology and recombinant protein production. Although we are an academic centre we work very much like industry. The team that I lead within the CCDD is called the Hit Discovery and Structural Design Team.

Fragment Screening

Fragment Screening Biochemical Assays Small Molecule Biophysical Assays

BetterLife Engages Eurofins Discovery for its Next Generation Psychedelics 2-bromo-LSD FDA IND-enabling Pharmacology Studies

The Pharma Data

JANUARY 27, 2021

Utilizing drug delivery platform technologies, BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus.

FDA

FDA Synthetic Chemistry Assay Development Treatment

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

The Premier Consulting Blog

OCTOBER 26, 2022

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).

Production

Production Assay Development Clinical Supply Clinical Development

The essential role of recombinant phage display antibody libraries

Drug Target Review

OCTOBER 3, 2024

In light of these key developments, the need for flexible yet highly specific and sensitive tools that provide vital information on a drug’s safety and efficacy are essential to help determine the best drug candidates for preclinical and clinical progression. Adapted from Harth S et al. (8) 8) under a CC BY-NC-ND 4.0.

Molecular Biology

Molecular Biology Pharmacokinetics Laboratories Animal Testing

The hidden risks of over-reliance on healthy donor material

Drug Target Review

OCTOBER 10, 2024

By promoting partnerships between biobanks, research institutions, regulators, and industry, we can create networks for information sharing, streamline access to diseased donor material, and facilitate joint research initiatives. Furthermore, fostering cross-industry collaboration is essential.

Therapies

Therapies Immune Response Clinical Trials Disease

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

JULY 21, 2023

For more information, read FDA’s 2019 draft guidance on substantial evidence here.] Finally, since the technique can provide information about tumor genetics and mutations, ctDNA can also be used to help selected directed therapies. In the last few years, the group has evaluated the use of ctDNA to track long-term outcomes.

FDA

FDA Clinical Trials Treatment Trials

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

FEBRUARY 2, 2024

The fifth update accounted for the impact that changes in the therapeutic landscape had on safety data reporting requirements, which also inform the benefit-risk evaluation. Briefly addressing companion diagnostics, the guideline advises that sponsors consider co-development of a companion diagnostic and the medicinal product.

Clinical Trials

Clinical Trials Trials Treatment Disease

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

Conversations in Drug Development Trends

JANUARY 6, 2025

They also play a vital role in monitoring disease progression and treatment response, offering real-time data that informs adjustments to trial protocols. Ready-to-Use Assays : Reduces study timelines and costs by 40-50% with validated methods for direct biomarker analysis.

Clinical Trials

Clinical Trials Trials Drug Development Therapies

Drug Discovery Digest

High Throughput Screening (HTS)

New image-based cellular profiling tool peers deeply into metabolic biology

Trending Sources

Biophysics

Sygnature Discovery’s hit finding expertise in high demand as cardiac biotech customer, River BioMedics, receives an additional €2M seed investment

Choosing the Best Bioanalytical Platform for Your Program

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

Target-directed cancer: protein-ligand interactions

BetterLife Engages Eurofins Discovery for its Next Generation Psychedelics 2-bromo-LSD FDA IND-enabling Pharmacology Studies

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

The essential role of recombinant phage display antibody libraries

The hidden risks of over-reliance on healthy donor material

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

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

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