Lipum and NorthX Biologics – a deep dive into the collaboration and production process
Lipum has initiated the manufacturing process of SOL-116 for phase II studies in collaboration with the company’s partner, NorthX Biologics, a leading manufacturer of advanced biological drugs. BioStock reached out to Janet Hoogstraate at NorthX Biologics to learn more about the manufacturing process.
Lipum is developing a biological drug, specifically a monoclonal antibody, that inhibits Bile Salt-Stimulated Lipase (BSSL) which is a protein that is key in sustaining chronic inflammation. By targeting BSSL, Lipum offers a novel therapeutic approach to treating chronic inflammatory diseases, initially focusing on rheumatoid arthritis (RA).
The company’s drug candidate, SOL-116, is currently being evaluated in a phase I clinical trial. The next step in development is to initiate a phase II study, which requires the production of additional quantities of the drug substance.
Complexity in the manufacturing of biologics
Precision is key when producing biological drugs, as the manufacturing process is complex and costly, with long lead times. Unlike small-molecule drugs, which are made through chemical synthesis, the active substance in biological drugs is derived from biological sources, such as living cells and tissues.
The production of a biological drug substance is often more complex than that of a traditional chemical substance. For Lipum’s antibody SOL-116, the process includes cell cultivation, scaling up to the correct volume, purification of the antibody from the cell culture, and rigorous quality control measures.
Agreement with NorthX Biologics
Lipum has chosen NorthX Biologics as contract manufacturer of SOL-116 for the upcoming phase II clinical trials. NorthX Biologics is an expert in the GMP manufacturing of biological drugs, with two facilities in Sweden, and a headquarter and innovation hub in Matfors.
Previously, Lipum had an American contract manufacturer, but the company has now switched to NorthX Biologics to reduce costs and shorten lead times, while maintaining high quality. Moving production back to Sweden minimizes the need for long transports, and collaboration is simplified as the time difference is eliminated. Additionally, the risk of currency effects is avoided.
The manufacturing project is underway
In April, Lipum entered into a framework agreement and a project agreement with NorthX Biologics for research, development, and manufacturing in preparation for the phase II trials with SOL-116. The company has already paid SEK 52 million for the first project agreement, which includes nine work packages.
The work packages cover all activities, from initial development to manufacturing and releasing the investigational drug products for phase II trials. In addition to producing the drug substance, NorthX Biologics will also be responsible for vial filling, analytical work, and subsequent storage and stability studies.
– NorthX’ s capabilities are a great fit and provide a cost-effective one-stop shop for both drug substance and sterile fill-finish drug product. I am very much looking forward to the collaboration and bringing this therapy a step closer to patients, CEO Ola Sandborgh writes in a press release.
NorthX Biologics shares details about the manufacturing
According to Lipum’s Q2 report, the manufacturing process for SOL-116 has already begun and is expected to take 18 months from start to finish. BioStock interviewed Janet Hoogstraate, CEO of NorthX Biologics, to better understand the manufacturing process and their role as a partner.
First and foremost, what makes NorthX Biologics an ideal manufacturing partner for Lipum?
– NorthX Biologics has extensive experience manufacturing biologics, which we apply when setting up production processes and analyses. It is rarely a plug-and-play scenario, and our staff has the right expertise to handle this and a commitment to fostering a good relationship with our clients. To succeed, we need to build and maintain trust.
– NorthX Biologics offers the full range of services that Lipum requires, from manufacturing the substance and product filling to quality control through analysis and assurance of the manufacturing process, ensuring the product can be used in clinical trials.
What is important to consider in manufacturing SOL-116 and biological drugs in general?
– Biological drugs are produced in biological systems, i.e., living organisms, which is different from chemical synthesis. The process is the product and all its documentation for biological drugs. The process must be repeatable and scalable, which may sound obvious, but challenges can arise with biological systems. Maintaining complete control throughout the entire process is essential, from how the cells grow to harvesting and through all purification steps, right down to the final product.
How far along are you in the manufacturing process?
– We have run the SOL-116 process on a small scale to confirm comparability, ensuring that the cells grow like they did with the previous manufacturer. Later this fall, we will proceed with producing a technical batch on a larger scale.
Are there any similarities or differences between SOL-116 and other drugs you have manufactured?
– There are similarities with other substances we have produced, as we have worked with similar expression systems and purification processes. Still, each process is unique and is optimized based on the properties of the substance and previous results. Many analytical methods are also used for other substances, but there are specific methods that are unique to this substance.
Finally, how do you ensure good stability and patient safety?
– The stability of a drug is tested in stability studies with associated analyses. Through meticulous documentation, we ensure traceability and quality assurance in accordance with current regulations
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
