Newsletter | November 28, 2023

11.28.23 -- FDA Seeks Comment On New Draft Guidance On Peptide Drug Product Pharmacology



FDA Seeks Comment On New Draft Guidance On Peptide Drug Product Pharmacology

The FDA has announced a new draft guidance titled Clinical Pharmacology Considerations for Peptide Drug Products. This guidance describes recommendations related to hepatic impairment, drug-drug interactions, assessing QTc prolongation risk, and more. The public comment period ends December 11, 2023.


Demonstrating Control Over The Manufacturing Process: QbD Studies

Understand the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal.

Diagnose Absorption Risks To Improve Preclinical And Clinical Outcomes

Physiologically based pharmacokinetic modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and accelerate timelines.

Improving Efficiency In Cell Line Development

As the cost of developing a biologic drug remains high, explore ways to improve your CLD process by eliminating bottlenecks in clone selection, fast-tracking timelines, and reducing costs.

The Flux Performance Of Nanoformed And Untreated PRX Solid Suspensions

Explore the application of in vitro flux assays to nanoparticles, with data on how the in vitro permeability apparatus can characterize the membrane flux performance of an API formulated as a nanosuspension.

Simultaneous Spray Drying: Dry Powder Inhaler Combination Formulations

The simultaneous spray drying of multiple ingredients is a powerful technique for making inhaled products with multiple actives. Examine how novel techniques can make these products a reality.

Drug Product Process Characterization For Liquid And Lyophilized DP

Explore important initial steps to consider and implement during the process design phase, which is a prerequisite to a successful PPQ campaign and readiness for commercial manufacturing.


Genentech & NVIDIA Enter Into Strategic AI Research Collaboration

HOOKIPA Pharma Announces FDA Clearance Of Its IND Application For HB-500

Cell-Free Quest For New Antibiotics

Sanyou's ‘STAL Platform’ Is A Significant Advancement In The Field Of Drug Discovery

PostEra Announces A Research Collaboration With Amgen

Momentum Biotechnologies & Axxam S.p.A. Announce Collaboration

University Of Tsukuba And Astellas Confirm A Strategic Partnership

Three Drugs Target Resistant Breast Cancers Driven By HER2 Mutations

Immix Biopharma Announces FDA Approval Of IND Application For CAR-T NXC-201

FDA Grants Orphan Drug Designation To NeoImmuneTech's NT-I7

New Process For Screening Old Urine Samples Reveals Previously Undetected ‘Designer Drugs’


Capacity Update October 2023

Continuous Flow

Is The Sensitivity Of Optical Biosensors Important?


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