ProBioGen and Marea Therapeutics have announced the successful completion of a comprehensive Chemistry, Manufacturing, and Controls (CMC) development program for MAR002, a novel antibody therapy targeting acromegaly. The milestone marks a significant advancement in bringing a potential first-in-class treatment option to patients with this rare endocrine disorder.
Technical Achievement in Antibody Development
The development program leveraged ProBioGen's proprietary CHO.RiGHT® cell line development platform and DirectedLuck® transposase technology to generate high-yielding clone pools. This technical achievement enabled early material production crucial for IND-enabling toxicology studies. The platform's stability facilitated the development of a robust, scalable manufacturing process that seamlessly integrated with downstream drug product manufacturing.
Dr. Alfred Merz, Chief Executive Officer of ProBioGen, emphasized the project's success: "This collaboration exemplifies our customer-centric approach and our ability to support biotech companies with innovative and flexible solutions, enabling a sprint to IND to meet their challenging timelines."
Strategic Partnership and Development Progress
The partnership between ProBioGen and Marea Therapeutics represents a fee-for-service arrangement focused on accelerating MAR002's development timeline. The collaboration encompassed multiple critical aspects of drug development, including:
- Cell line development
- Process development
- Formulation optimization
- GMP manufacturing services
Mark Joing, Chief Development Operations Officer of Marea, highlighted the significance of the partnership: "MAR002 holds promise as a first-in-class treatment for acromegaly, a life-shortening disease often with serious complications. We appreciate ProBioGen's support throughout the process and look forward to continuing our collaboration as we advance to the next stages."
Manufacturing Excellence and Quality Standards
ProBioGen's Berlin-based facilities, staffed by 300 employees across four locations, provided comprehensive development services while maintaining strict compliance with EMA/FDA standards. The company's integrated approach to biopharmaceutical development has been refined over nearly three decades of operation.
The successful completion of these CMC milestones positions Marea Therapeutics to advance MAR002 toward clinical trials and eventual commercialization. The development program's success demonstrates the effective combination of ProBioGen's technical expertise with Marea's innovative therapeutic approach in addressing unmet needs in endocrine disorders.
