According to a new Frost and Sullivan report, “Preparing for Next Generation of Biopharmaceutical Manufacturing,” the bioindustry industry is facing “its biggest test in recent times” due to new disease outbreaks, the urgency for innovative therapies, and the emergence of non-traditional products such as bispecific antibodies and cellular therapies. Biopharma will be compelled “to adopt new manufacturing approaches.”

Primary drivers include cost reduction and scalability, particularly for downstream operations. Biopharmaceutical developers can achieve these benefits by “adopting advanced manufacturing technologies, establishing public-private partnerships and placing sustainability at the core of the business strategy.”

The Frost & Sullivan study analyzes six “dynamic trends” that will revolutionize business-as-usual, including adopting new technologies and next-generation manufacturing methods, optimizing clinical development costs, exploiting recombinant DNA technologies to their fullest, single-use manufacturing, and process analytics. These technologies are interwoven with ideas GEN readers have been reading about: advanced materials, platform processes, agility, multi-dimensional collaboration.

The study discusses complete integrated process workflows allowing rapid creation of manufacturing capacity. Once broader infrastructure and architecture is in place, companies can accelerate their lab-to-manufacturing scale initiatives for a wide range of situations.

Sustainability Efforts

According to the report, biopharmaceutical companies must “review investments beyond the traditional growth levers of clinical and commercial excellence and intensify efforts related to sustainability.”

GEN asked Nitin Naik, global practice area leader, healthcare & life Sciences, at Frost & Sullivan, why such profitable, high-tech companies need to innovate further?

“The need to launch innovative therapies, such as cell and gene therapies or mAB combination therapies, faster and at lower cost has pushed biopharmaceutical industry to innovate. Benefits include support for ever-expanding pipelines and, most importantly, the ability to step up the manufacturing footprint in terms of productivity and scaleup across global sites,” Naik said.

The Frost & Sullivan report also mentions “custom technologies” developed to meet next-generation mAb processing requirements. Naik explained that new mAB, cell, and gene therapies have vastly different purification requirements based on size, chemistry, and physical properties, which requires developers “to customize approaches to downstream filtration technologies,” among other purification methods.

If the technology exists and saves money, why isn’t everyone adopting it, particularly for new facilities? The devil is in the details.

“Proof of concept using automation or continuous processing have demonstrated cost reductions and/or higher productivity. However, these approaches rely on consistent equipment performance and access to sophisticated process analytical tools,” pointed out Naik. “Equipment performance variation across global sites remains a challenge and so does integration.”