02.16.24 -- FDA Issues Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene

As demand for more precise, tailored CRO services grows, so does the emphasis drug developers place on their partners’ flexibility, agility, and enthusiasm for collaboration.

Examine challenges and key considerations for spray-dried formulations for inhalation, along with a review of current technologies and approved products utilizing particle engineering approaches.

There are two basic models of pharma manufacturing: batch and continuous. Here, we compare the two and examine the challenges they bring to containment product design.

Nanoparticle engineering has emerged as a promising solution for enhancing drug solubility and bioavailability and improving efficiency within the drug development pipeline.

Current advances in cell, gene, and tissue therapies require a rethinking of how — and where — cleanroom manufacturing facilities could be built, enabling more options for sponsor process control.

Discover how PBPK models, combined with in vitro tools and solubility enhancement expertise, can be used to identify and mitigate absorption risks in early drug development.

Find the right solutions for your organization to comply with and maintain product quality and safety despite conflicting cGMP FDA 21 CFR Part 210 and 211 cleanroom and BMBL requirements.

Characterizing Fab and Fc-Fusion proteins and developing robust manufacturing processes can help usher them to market and provide new treatment options for diseases that are challenging to treat.

Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.

Review how to select the right polymers and ensure you have a robust formulation strategy when aiming to transfer tech or scale up modified release formulations.

Protection against counterfeit products is becoming increasingly important to international pharma companies. Learn how one solution enables August Faller KG to offer an extensive range of services.

A study was conducted to evaluate the SampleGenie system and determine if it is suitable for replacing several manual process steps. Explore the methods and results of this investigation.