A recent article in BioStock details how Lipum has begun the manufacturing process of SOL-116 for Phase II studies, in partnership with NorthX Biologics, a leading manufacturer of advanced biological drugs. SOL-116 is a monoclonal antibody that inhibits Bile Salt-Stimulated Lipase (BSSL), a protein crucial for sustaining chronic inflammation, initially targeting rheumatoid arthritis. The production of biological drugs is complex and costly, requiring precision and long lead times. Lipum chose NorthX Biologics as their contract manufacturer to reduce costs and lead times while maintaining high quality.
The collaboration involves NorthX Biologics handling the entire manufacturing process, including cell cultivation, scaling up, purification, quality control, vial filling, analytical work, and stability studies. The manufacturing process is expected to take 18 months and has already begun. NorthX Biologics has extensive experience in manufacturing biological drugs and offers a cost-effective, comprehensive solution for both the drug substance and sterile fill-finish. The partnership aims to bring this therapy closer to patients.
Read full article here.
NorthX Biologics is a CDMO and Innovation Hub in Advanced Biologics, with +30 years of GMP production experience. The team provides process development and GMP manufacturing services with expertise in plasmid DNA, mRNA, proteins, cells and other advanced biologics. Headquartered in the heart of Sweden, the team serves customers worldwide and in 2021 was recognized as a national innovation hub for advanced therapeutics and vaccines. NorthX Biologics has the ambition to become a leading cell and gene therapy manufacturer and partner of choice for innovative drug development companies.
For more news, follow us on LinkedIn
Abstract Negar Ordouzadeh, Rossella Crescitelli, Agnes Zimmer, Petra Tjärnlund, Cecilia Lässer, Jan Lötvall, Kyong-Su Park Bacterial vesicles have emerged as therapeutic drug candidates to treat a wide range of diseases, including cancer. However, critical concerns remain ...
The complex journey of bringing a biologic to market – part 3 It is a critical shift for companies when transitioning from early development to clinical production, where you transfer ...
Viral vaccines are entering a new era Vaccines have played a pivotal role in controlling infectious diseases for more than a century. Often regarded as one of the most impactful ...