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Industry updates · Page 23

Follow sourced scientific, clinical, partnership, capacity, and financial developments. Factual summaries and business interpretations are presented separately.

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Chemical and Pharmaceutical Bulletin

Combination of Microcrystal Electron Diffraction and Solid-State NMR for the Structural Determination of Indomethacin–Nicotinamide Co-crystals

This study characterized indomethacin–nicotinamide cocrystals using MicroED together with solid-state NMR, Raman spectroscopy, and powder X-ray diffraction. MicroED supplied the crystal structure, while NMR helped examine molecular interactions. The combined approach addressed properties that individual methods could not establish alone, offering a pharmaceutical cocrystal workflow relevant to API powders and formulations containing excipients.

Acta Crystallographica Section C

Standards for MicroED

This standards article examines lessons from the growing body of refined MicroED structures and accessible diffraction data. It discusses quality indicators and proposes community best practices for assessing and reporting results. The recommendations provide a framework for critical evaluation rather than regulatory certification or a guarantee that every structure meets the same quality threshold.

New England Journal of Medicine

Vepdegestrant, a PROTAC Estrogen Receptor Degrader, in Advanced Breast Cancer

In the randomized phase 3 VERITAC-2 trial, vepdegestrant improved progression-free survival versus fulvestrant in the ESR1-mutated subgroup, but not significantly in the overall population. The trial enrolled 624 patients with previously treated ER-positive, HER2-negative advanced breast cancer. Grade 3 or higher adverse events occurred more often with vepdegestrant.

Pharmacological Reviews

Pharmaceutical perspectives on oligonucleotide therapeutics and delivery systems

This review examines RNA species, structure and function, chemical modifications, and delivery systems in the context of therapeutic development. It connects molecular design with stability and distribution and discusses clinical applications available at the time of writing. Its historical approval overview should not be interpreted as a current, exhaustive drug list.

Molecular Pharmaceutics

Structural Analysis of Active Pharmaceutical Ingredients in Tablets Using 3D ED/MicroED

The study examined API crystals directly in Allegra, Clarith, and Ibrance tablets using selected-area 3D ED/MicroED. Fexofenadine hydrochloride Form I and clarithromycin Form II retained their polymorphs, while palbociclib Form A showed slight lattice shrinkage. The results demonstrate formulation-level structural analysis and emphasize that a lattice change and a new polymorph are different findings.

Nature

Mass-spectrometry-based proteomics: from single cells to clinical applications

This review surveys improvements in proteomics sample preparation, instrumentation, data acquisition, and analysis. It connects single-cell and spatial profiling with protein interactions, modifications, and biomarker discovery in body fluids. Clinical implementation is discussed as an opportunity with remaining challenges, rather than proof that every discovery assay is ready for diagnostic use.

IUCrJ

SCXRD, CSP-NMRX and microED in the quest for three elusive polymorphs of meloxicam

Three elusive meloxicam polymorphs required different structure-determination approaches. Single-crystal X-ray diffraction solved Form III, combined crystal structure prediction and NMR crystallography solved Form II, and electron diffraction resolved Form V, which contains four independent molecules in the asymmetric unit. The comparison highlights complementary strengths and limitations rather than establishing one universally superior crystallographic method.

IUCrJ

From formulation to structure: 3D electron diffraction for the structure solution of a new indomethacin polymorph from an amorphous solid dispersion

3D electron diffraction resolved the structure of the ninth reported indomethacin polymorph, designated sigma, from crystals found within an amorphous solid dispersion. Subsequent experiments produced the same form by solvent evaporation. The work demonstrates structure determination directly from a formulation-related sample containing an excipient; it does not establish improved dissolution or clinical performance for the new form.

Crystal Growth & Design

Polyethylene Glycol-Assisted Melt Crystallization of Two New Piroxicam Polymorphs Revealed by 3D Electron Diffraction

Two previously unreported piroxicam polymorphs, Forms VIII and IX, emerged through polyethylene glycol-assisted melt crystallization. Their crystal structures were determined by 3D electron diffraction. Comparing the newly solved Form VIII with known Form IV allowed discussion of how differences in intermolecular hydrogen bonding contribute to melting behavior. The study concerns laboratory solid forms rather than validated drug-product performance.

Organic Letters

Structural Elucidation and Absolute Stereochemistry for Pharma Compounds Using MicroED

This industry-linked evaluation examined 30 samples from Amgen process and medicinal chemistry groups. Fifteen crystal structures were elucidated using 40 hours of microscope time. For the chiral compounds whose structures were solved, dynamical refinement assigned the correct absolute stereochemistry. The study provides an observed sample-set outcome rather than a universal success rate for pharmaceutical materials.

Chemical and Pharmaceutical Bulletin

Rapid Structure Determination of Ranitidine Hydrochloride API in Two Crystal Forms Using Microcrystal Electron Diffraction

Researchers used MicroED to determine the crystal structures of ranitidine hydrochloride Forms 1 and 2. The resulting structures agreed with previously reported X-ray diffraction structures. The work presents a focused pharmaceutical proof of applicability for small-quantity or microcrystalline API samples, while retaining the need to control crystal form, hydration, and residual solvents through complementary quality assessments.

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