In the fast-paced world of biopharmaceuticals, speed and efficiency are vital. At mAbxience, we understand the critical need to expedite the journey from gene discovery to clinical trials. We are introducing our “Gene to Biologics Drug Substance (BDS) in 12 Months” program, an IND enabling solution designed to accelerate the development of monoclonal antibodies, from concept to clinical trials.
Transforming Concepts into Clinical Candidates
Our program is designed with one goal in mind: to convert groundbreaking lab concepts into tangible medicines ready for clinical trials within just 12 months. This rapid timeline allows biotechnology and pharmaceutical companies to bring new therapies to first in human studies faster.
Key Benefits of Our Program:
- Rapid IND/CTA Filing:
- We streamline the process and analytical development, enabling efficient filing of Investigational New Drug (IND) or Clinical Trial Application (CTA). This speed is crucial for competing in the current biopharmaceutical landscape.
- Comprehensive Regulatory Support:
- Our program includes a robust regulatory package that meets the stringent requirements of major regulatory agencies such as the EMA and FDA. With our thorough documentation, no additional work packages are needed, ensuring a smoother and faster progress.
- Accelerated Clinical Development:
- By converting lab discoveries into clinical trial-ready substances efficiently, we help our partners shorten the time to clinic. This acceleration is vital for delivering life-saving treatments to patients sooner.
Why choose mAbxience?
mAbxience leverages its extensive experience in biologics to provide top-tier CDMO services. Here’s what sets us apart:
- Proven Track Record: Over 14 years in biologics development, with three commercial products on the market and many more in clinical stages.
- State-of-the-Art Facilities: Our cGMP multi-product facilities in Spain and Argentina feature modern single-use technology, ensuring flexibility and scalability.
- In-house R&D excellence center: with cutting-edge technology in Upstream, Downstream and Analytics equipment, supporting fastest and success developments.
- Comprehensive Capabilities: From small-scale to large-scale production, our facilities support a wide range of manufacturing needs with a total of 50,000L mammalian cell culture capacity.
- High Success Rate: More than 98% batch success rate, reflecting our commitment to quality and reliability.
- End-to-End Services: We offer integrated operations, including Drug Product manufacturing and packaging, providing a seamless experience from development to market launch.
Partner with Us for Rapid Biologics Development
Are you ready to accelerate your biologics development and bring innovative therapies to patients faster? Contact us today to learn more about how our “Gene to Biologics Drug Substance (BDS) in 12 Months” program can support your development needs and help you stay ahead in the competitive biopharmaceutical industry. Reach out to us at contact@mabxience.com.
