Biogenera Achieves a Historic Milestone: GMP Production of BGA002 API Completed

Biogenera has reached a landmark moment in its R&D journey by successfully completing the production of the API (Active Pharmaceutical Ingredient) for BGA002, the most advanced anti-cancer drug in its pipeline.

BGA002 was developed using PNA (Peptide Nucleic Acid) technology and Biogenera’s proprietary MyGenera™ platform, specifically designed to selectively silence the MYCN gene, implicated in numerous aggressive pediatric and adult cancers.

A New Large-Scale Pharmaceutical Process

Rispetto ai quantitativi sinora realizzati per gli studi preclinici, Biogenera ha messo a punto un processo farmaceutico completamente rinnovato per la produzione di BGA002 su larga scala.
Questo rappresenta un passaggio cruciale, che permette di garantire quantità, qualità e riproducibilità del principio attivo necessarie al suo impiego in clinica.

Manufactured to the Highest International Standards

BGA002 has been produced following Good Manufacturing Practice (GMP) guidelines—an international standard ensuring the highest levels of quality, safety, and traceability in drug production for human use. This guarantees that the drug meets globally recognized standards of purity and manufacturing integrity, safeguarding patient safety.

From API to Clinical Trial Readiness

The API—the pure, stable powder at the heart of the drug—is now ready for the fill-finish phase (aseptic vial filling). This step will make the drug available for its first clinical administration.

In the coming weeks, BGA002 will be prepared to enter a Phase I clinical trial involving pediatric patients with aggressive tumors resistant to conventional therapies.

A Pivotal Step for Biogenera

• It signifies the transition from preclinical research to industrial-scale, clinical-stage development.

• It strengthens the quality and reproducibility of our drug candidate.
• It officially paves the way for clinical advancement of an innovative therapeutic approach.

Where Science Meets Hope

With this milestone, Biogenera reaffirms its mission: to deliver new therapeutic options to children and adults affected by aggressive cancers, where current treatments fall short.

More than ever, science meets hope.