Newsletter | February 6, 2024

02.06.24 -- A New Year's Resolution Suggestion For The FDA

FEATURED EDITORIAL

A New Year’s Resolution Suggestion For The FDA

Many pharma and biotech companies have continuing compliance problems when getting inspected by our friends at the FDA. Here, this industry observer with almost 50 years of experience shares some New Year's resolution wishes for the FDA, and, by extension, industry members can consider the list as the foundation for sustainable quality in operations.

INDUSTRY INSIGHTS

Minimizing API Supply Chain Risks

Partnering with an API CMO can help you navigate challenges you may encounter, ensuring you are using the best quality practices and minimizing delays in getting those medicines to market.

An Elegant Solution For Delivery Of Acid-Sensitive Pharmaceuticals

Sustained-release drug delivery products offer effective therapies in the treatment of serious chronic diseases, and their development requires customized solutions with tunable material properties.

5 Steps To Improving Productivity In Pharma Manufacturing

Increased output, greater product consistency, and decreased costs are just some of the benefits of improved productivity. This guide for achieving long-term success can aid your efficiency journey.

An Introduction To Data Models And Modeling For Pharma 4.0

The foundation for standardizing data across a wide range of raw input data lies in the data model. Explore six commonly asked questions people have when considering a data-modeling solution.

Route Development: Designing Synthesis For GMP Production

The successful transition from the initial synthesis of an API to a kilogram-scale route requires expert analysis and design, and a balance of economic, regulatory, and time constraints.

PBPK Modeling For Optimized Controlled Release Formulation Development

Examine the benefits of controlled release, the application of PBPK modeling in formulation development, and how modified release products can be developed to deliver optimal patient outcomes.

Avoiding The Pitfalls Of LNPs And Complex Formulations

Discover the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.

High-Shear Mixer Considerations For The Cannabis Industry

Learn about high-shear mixers and how they can be used in a variety of ways to create cannabis-infused products.

Optimizing LC-MS For Biopharmaceutical Analysis

Explore expert insights into newer, faster, and more efficacious strategies for peptide mapping, the analysis of novel biotherapeutic products, and more.

The History Of Microcalorimetry

Here, we review the beginnings of calorimetry and microcalorimetry, along with their modern history, applications, and use in biologics drug development.

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.

The Path To Commercialization For Wearable Drug Delivery Devices

Gain insight into the evolution of the wearable drug delivery market, including the route to commercialization and the challenges faced.

SOLUTIONS

Primary Drug Containers

Single-Use TFF System Configurable For ADC Synthesis

Biopharma Manufacturing Process Data Made Simple

Engineered Containment Solutions From Research To Production

Selecting An Affinity Chromatography Resin For Your Antibody

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