BioPharm International | Maximum Output Starts with Optimized Upstream Processing

Significant growth in the development and manufacturing of biologics—from traditional recombinant proteins and monoclonal antibodies (mAbs) to advanced multispecifics, antibody-drug conjugates, viral oncolytics, and cell, gene, and gene-editing therapies—was occurring worldwide before the emergence of the COVID-19 pandemic. Demand for biosimilars is also increasing. The requirements associated with COVID-19 vaccine manufacturing are placing further pressure on upstream manufacturing capacities.

“The situation is evolving as the industry continues to explore the right balance between internal capacity/capability and external capacity/capability and key strategic partnerships,” says Lynn Bottone, vice-president of Pfizer Biotech Operations. “Generally, the industry doesn’t have idle capacity across key technologies to bring on line with immediate effect. The challenges of the last year have made the industry revisit and reconsider these options with a rethinking of certain approaches,” she adds. That includes the supply of key inputs to upstream processes as well.

As a result, a strong and sustainable supply network is more vital to ensure supply chain stability, according to Youngsun Kim, director of the manufacturing science and technology team at Samsung Biologics. “Global sourcing of raw materials is an integral part of the supply chain, but recent events have highlighted that relying only on a single source can increase risk during a crisis. Many companies are looking to diversify their supply chains to reduce the risk of disruption in the future,” he says.

Equipment suppliers, contract manufacturers, and biopharmaceutical companies are implementing new bioprocessing solutions and manufacturing strategies to increase efficiency and productivity, forging innovative partnerships, and investing in additional physical capacity on a global basis.

Evolution in bioprocessing

The increasing diversity of advanced therapies has driven upstream manufacturing processes to evolve, according to Philip Vanek, CTO at Gamma Biosciences. “The latest iteration of technologies is being developed with scalability, process intensification, and lean principles in mind to ensure quality and reliability for the life of a process,” he asserts.

Process flexibility and technical innovations are key strategies to accelerate the pace of process development while increasing upstream capacity, adds Dirk Lange, CEO of Selexis and president and CEO of KBI Biopharma. “Accelerating processes means going into manufacturing faster, and with that there can be bottlenecks. CDMOs [contract development and manufacturing organizations] must provide flexibility to address bottlenecks, like taking the most streamlined path possible, decoupling upstream and downstream processes, and managing technical risks more effectively (i.e., using new technologies that help create flexibility),” he explains.