Newsletter | July 15, 2025

07.15.25 -- Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations

FEATURED EDITORIAL

Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations

The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).

INDUSTRY INSIGHTS

Missing Pieces Of The Upstream Process Intensification Puzzle

If downstream risks from higher upstream titers hinder your process intensification, PAT and Data Analytics are key. Explore how these tools provide control to mitigate risks and optimize production.

Increasing Spray Drying Throughput For Brick Dust Compounds

‘Brick dust’ compounds require additional steps if spray drying is to yield a commercially attractive process. Explore three enabling technologies designed to improve drug solubility in organic solvents.

Reducing Wastewater Incineration And Carbon Emissions

To reduce CO2 emissions and recycle higher volumes of solvent, drug manufacturers must engineer specialized approaches with flexible technologies that can be adapted.

Simplify CAR-T Cell Manufacturing With LNP-Mediated Delivery

Streamline CAR-T cell manufacturing with lipid nanoparticles delivering base editors to create fratricide-resistant, CD45-edited CAR45 T cells, which enables potent therapies for blood cancers.

SPONSOR

ChemOutsourcing 2025 is the leading U.S. conference for small molecule API, peptide, oligonucleotide, and drug development services. Held September 2–5 in Parsippany, NJ, it attracts biotech and pharma buyers seeking CDMO partners. With 100+ global CDMOs, expert panels, and targeted networking, it’s the go-to event for small molecule, peptide, and oligo outsourcing, connecting innovators across the global pharmaceutical supply chain.

SOLUTIONS

Digital PCR System And 21 CFR Part 11 Regulations

Achieve Highly Sensitive And Precise Binding Affinity Measurements Without Disrupting Protein Conformation

Cambrex Scientist Spotlight: Elena Bejan