Pharma CDMOs and big picture details
Today’s pharma contract development and manufacturing organizations have to do both. CDMOs are winning over clients by not only taking on major global challenges, but also by providing expertise in their respective processes.
On the surface, we see CDMOs tackling big issues: stopping COVID-19, enabling the next generation of medicines, and slowing climate change.
This month, we highlighted four companies as “CDMOs with vision” — but it quickly became evident that vision alone did not make them successful. Behind the scenes, we saw skilled industry experts who were meticulous about the details…
A one-stop-shop for advanced therapies
Sometimes tackling major challenges requires a major response. In the case of the Center for Breakthrough Medicines (CBM), that has meant building the world’s largest single-site CDMO dedicated to end-to-end development and manufacturing for cell and gene therapies.
In January 2020, the newly formed CBM announced its intention to build a behemoth 680,000-square foot facility inside the 1.6-million square foot Discovery Labs life science campus, a innovation hub dedicated to supporting development and manufacturing of advanced therapies based in King of Prussia, Pennsylvania. In its announcement, the company said that the $1.1 billion undertaking was aimed at addressing the “critical lack of capacity that is preventing patients from accessing critically needed cell and gene therapies.”
CDMOs with vision
Contract manufacturers must continue to meet global, non-pandemic needs. Many are ramping up to respond to the growing demand for cell and gene therapies — novel and complex biologics at the forefront of innovation for treatment of severe diseases, such as cancer — that have suffered from supply delays.
Two new and promising CDMOs have recently entered the scene in this buzzing sector. The Center for Breakthrough Medicines, set to be fully operational by 2022, is promising to be the biggest cell and gene therapy CDMO in the world, using cutting-edge technologies to provide a one-stop shop with end-to-end advanced therapy production…
Getting Bioprocessing Up to Speed
Dana Cipriano, vice president of testing and analytical services, Discovery Labs, Center for Breakthrough Medicines:
“The key to increasing the efficiency of bioprocessing is developing robust platform processes with enhanced productivity and recovery that maintain safety and quality profiles. For cell and gene therapy products, it is extremely important to focus on early method development for characterization of efficacy and safety of the product. New technologies for enhanced analytics provide repeatable quality results, increasing the speed of process development. Process platforms should include fully-integrated automation solutions for continuous monitoring and characterization, increasing the right-first-time percentage. This must be further supported by robust supply-chain solutions with integrated testing to facilitate both raw materials and product release.”
Collaboration Takes Cell and Gene Therapies Closer to Their Full Potential
In September 2020, the first patient was dosed with autologous chimeric antigen receptor (CAR-T) lymphoma treatment using an automated closed system. “Despite complex and mainly manual processes, we can produce these therapies. Now we must work on making processes reproducible,” says Joerg Ahlgrimm, president and chief operating officer at The Discovery Labs, who was previously head of global C> operations at Lonza Pharma & Biotech.
Significant progress has already been made, he notes. “The fact that we can routinely upscale a viral vector to 200–500 L standard represents a huge accomplishment. Years ago, we could not even have imagined reaching this point. And now, we are approaching 2000-L batch sizes,” he adds. The Discovery Labs is building a Center for Breakthrough Medicines to accommodate 80 to 120 C> customer development programs at any point in time.
For now, the goals are clear, Ahlgrimm says: stable cell lines, better scalability, smaller footprints, and better automation. He sees autologous therapies dominating with adeno-associated virus (AAV) and lentivirus vectors the dominant vehicles for manufacturing…