ProtaGene Appoints Former Merck KGaA CDMO Executive Matthias Bucerius as CEO

• ProtaGene, a global contract research organization (CRO) specializing in advanced analytical services for biologics and cell and gene therapies, appointed Matthias Bucerius, PhD, as Chief Executive Officer, effective October 27, 2026. Bucerius previously served as Senior Vice President of the CDMO business at Merck KGaA, where he oversaw multiple drug substance manufacturing sites and led operations through FDA inspections.

• Bucerius will work alongside ProtaGene Presidents Roland Moussa and Mike Stump to strengthen regulatory-ready analytical services, improve project timelines, and maintain data quality across the company’s four sites in Europe and North America. The leadership appointment supports ProtaGene’s focus on GMP and GLP analytical testing, product characterization, comparability studies, and safety analytics for advanced therapies. 

ProtaGene, a global contract research organization (CRO) specializing in advanced analytical services for biologics and cell and gene therapies, announced on October 27, 2026, the appointment of Matthias Bucerius, PhD, as Chief Executive Officer, effective immediately. The appointment brings experienced CDMO leadership to the company’s analytical services operations across Europe and North America, strengthening its focus on regulatory compliance, data quality, and reliable project delivery for pharmaceutical and biotechnology clients.

Bucerius joins ProtaGene following his tenure as Senior Vice President of the CDMO business at Merck KGaA, where he managed multiple drug substance manufacturing sites and guided facilities through FDA inspections. His previous responsibilities also included overseeing life science businesses and commercial organizations across Europe, China, and the United States, providing experience in international operations, pharmaceutical manufacturing, and regulatory compliance.

As CEO, Bucerius will work alongside ProtaGene Presidents Roland Moussa and Mike Stump to advance three operational priorities: predictable project timelines, consistently high analytical data quality, and scientific capabilities that support faster drug development. The leadership team will focus on strengthening service delivery for biopharmaceutical companies developing complex biologics and advanced therapies that require specialized analytical testing throughout their development and commercialization lifecycles.

ProtaGene provides analytical services supporting pharmaceutical development from early-stage research through regulatory submissions and commercial product release. Its capabilities include GMP and GLP laboratory testing, protein and gene characterization, comparability and biosimilarity studies, and safety analytics for cell and gene therapies. These services help pharmaceutical developers generate analytical data required for Investigational New Drug (IND) applications, Investigational Medicinal Product Dossiers (IMPDs), marketing authorization submissions, and commercial manufacturing.

The appointment comes as developers of biologics and advanced therapies face increasingly complex analytical and regulatory requirements. Establishing consistent product characterization, demonstrating comparability, and generating reliable safety data are critical to regulatory submissions and product development timelines. ProtaGene’s leadership strategy emphasizes reducing analytical delays while maintaining the scientific and quality standards required by regulators in the United States and Europe.

“Every week saved in analytics can bring a therapy closer to patients.”

Matthias Bucerius, Chief Executive Officer of ProtaGene