Newsletter | June 1, 2023

06.01.23 -- Not All Plate Counting Technologies Are The Same

Featured Editorial
Industry Insights
How Your Stainless-Steel Column Is Like A French Press

Understanding how purification columns work can help operators better conceptualize the process, enabling greater process understanding and troubleshooting.

Application Of A Novel Temperature Shift Process For Particle Engineering

Spray drying of amorphous dispersions improves solubility and bioavailability that enables supersaturation in the intestine, driving higher rates of absorption when compared to crystalline drug forms.

How You Should Prepare For Foreign FDA Inspections

Ensure you understand the expectations of regulators and what you can do to facilitate successful paper-based inspections in lieu of those performed on-site.

Improve Biopharma Fermentation With Innovation, Collaboration

Organizations developing products requiring fermentation often create custom processes from scratch, leaving room for inefficiencies, lost value, and, in the case of significant error, costly time delays.

High-Throughput Developability Assessment Enables Efficient Formulation

The industry is focused on maximizing the effectiveness of early-stage candidate assessments to predict a molecule’s chances of success before investing heavily in that molecule.

Five Best Practices To Ensure Quality Active Pharmaceutical Ingredients

It is important to develop robust, reliable processes to safeguard APIs. Explore the best practices for providing patients with the highest possible quality of treatment that meets their therapeutic requirements.

Solid Form Strategies For Increasing Oral Bioavailability

Optimizing a drug’s solid form can improve its solubility and bioavailability when further molecular modifications are prohibitive.

Aseptic T-Cell Production For Cell And Gene Therapy Manufacturing

Achilles Therapeutics sources a customized aseptic processing solution to safely process irreplaceable personalized T-cell therapies.

Scale-Up And Site Transfer Of A Semi-Solid Product For Commercial Launch

Any changes to the equipment and processes used to produce a semi-solid dosage form may affect the physicochemical characteristics, bioavailability, and sensory qualities of the final product.

Overcoming Obstacles To Deliver Critical Autologous Cell Therapy

See how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany.

Cleanroom Design And Installation

Modular cleanrooms are both intricately engineered, high-performance machines and also durable, working facility structures. Learn how these cleanrooms are compatible with your manufacturing process now and in the future.

EU Med Device Regulations: Ensuring Compliance For Integral Combination Products

Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.

Environmental Sustainability: Wastewater Incineration Reduction

Discover an approach to wastewater treatment that reduces the environmental impact of small molecules production and introduces advanced treatment methodologies to avoid wastewater incineration.

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