Kenox reaches clinical manufacturing readiness for inhaled, nasal drugs

Kenox Pharmaceuticals, a contract development and manufacturing organization (CDMO) based in Monmouth Junction, New Jersey, announced it has reached clinical manufacturing readiness and expanded its GMP analytical testing capabilities for orally inhaled and nasal drug products (OINDPs).

The CDMO said the milestone enables integrated development, GMP testing and clinical manufacturing services for nasal and inhaled therapies under a single platform.

Kenox now supports small-scale fill–finish operations for small molecules, peptides, and biologics, with batch sizes ranging from hundreds to several thousand units intended for Phase I and Phase II clinical trials.

The company also expanded its analytical testing capabilities to include in vitro bioequivalence testing, a key component of development programs for inhaled and nasal drug products.

According to Kenox, its capabilities cover multiple delivery platforms, including nebulizers, soft mist inhalers, nasal sprays and dry powder inhalers. The company said its services include formulation development, OINDP performance testing, IVBE studies, and regulatory support packages designed to help developers advance products into clinical studies.

“By integrating development, GMP testing — including IVBE — and clinical manufacturing under one roof, we are significantly de-risking early-stage programs while delivering the speed, flexibility and quality that innovative OINDP products demand,” Xenox CEO Sitaram Velaga said in a statement.

Kenox said the expanded capabilities position the company to support programs across multiple therapeutic areas, including central nervous system indications using nose-to-brain delivery as well as pulmonary conditions such as asthma, chronic obstructive pulmonary disease, and pulmonary arterial hypertension.