FDA Law Blog: Biosimilars

JANUARY 24, 2024

is identified as “Improving Supply Chains for Critical Drugs,” and states: “ In 5 years, deploy broad synthetic biology and biomanufacturing capabilities to produce at least 25% of all active pharmaceutical ingredients (APIs) for small molecule drugs ” (emphasis added). The first goal under Theme 1—Goal 1.1—is

Small Molecule 69

Small Molecule Government Production Pharmaceuticals 69

Conversations in Drug Development Trends

APRIL 4, 2024

Stability Tests: For small molecule, only -20°C stability testing is required, while large molecule need both -20°C and -70°C tests if samples are intended for storage at these temperatures. Quality Control Batches : These batches are utilized to ensure the assay’s accuracy when measuring various study samples.

Small Molecule 80

Small Molecule Clinical Trials Pharmaceuticals Compliance 80

Drug Discovery World

SEPTEMBER 29, 2022

This white paper expands on three key factors – cost, time, and innovation – and illustrates how integrating these factors will minimise the challenges and ensure success in outsourcing drug discovery. protein-protein or small molecule-target interactions). Compound libraries: Small molecules, large roles.

Small Molecule 130

Small Molecule Assay Development DNA Biochemical Assays 130

Agency IQ

NOVEMBER 10, 2023

Read AgencyIQ’s analysis of FDA’s QMM White Paper here.] What the offices will focus on: OPQA I and II are set to focus on small-molecule product assessments. OPQA III will “focus on drug substance assessment for both large and small molecule products.”

Pharmaceuticals 40

Pharmaceuticals Small Molecule Science FDA 40

PerkinElmer

FEBRUARY 18, 2021

A PerkinElmer White Paper offers a detailed look at the findings. Small molecules are making a comeback. For the minority of companies working with large molecules and biologics, most said they were in a phase of clinical research. Top 10 trends in pre-clinical drug discovery at top 20 Pharma 1.

Biochemical Assays 52

Biochemical Assays Drugs Small Molecule Pharma Companies 52

Codon

APRIL 30, 2023

Read An automated platform to make riboswitches (RNA strands that bind to small molecules and then quickly switch their structure) that can sense specific proteins. Note: I’m employed by the company and a co-author on the paper.) Cell Systems. Nature Communications. Read That’s it for today! See you next week.

Vaccine 52

Vaccine DNA Engineering RNA 52

Codon

APRIL 30, 2023

Read An automated platform to make riboswitches (RNA strands that bind to small molecules and then quickly switch their structure) that can sense specific proteins. Note: I’m employed by the company and a co-author on the paper.) Cell Systems. Nature Communications. Read That’s it for today! See you next week.

Vaccine 52

Vaccine DNA Engineering RNA 52