The Multifaceted Future of Pharma – Chapter 5: Betting on Biopharma and Better Bioprocessing
Automation, conjugation, and collaboration have all contributed to the augmentation of biopharmaceutical manufacturing in the ten years since the launch of The Medicine Maker. But what factors will drive change and propel innovation over the next ten years? We asked a range of experts from the sector.
We asked: What has/have been the key disruptor(s) driving the industry over the past ten years, and how will this change in the next 10 years?
The March of the mAbs – with Sebastian Arana, Head of Process Solutions, Merck:
“The key disruption in the pharma industry has been the rise of biologics and their increasing relevance compared to small molecules. The first generation were protein-based therapies like monoclonal antibodies, which have demonstrated their therapeutic potential in a variety (and growing list) of indications – from oncology to immunology and several rare diseases.
“This wave created a variety of blockbuster molecules and gave rise to the bioprocessing industry, as therapeutic manufacturers were in need of purpose-built products to effectively manufacture these therapies. In particular, the emergence of single use as a technology fundamentally changed the manufacturing paradigm. The next wave of innovation created cell and gene therapies in the 2010s. During COVID, mRNA, another new modality, demonstrated its potential in the rapid design and production of vaccines.
“Over the next 10 years, we will see this trend to continue, rooted in deep pipeline funnels and sustained R&D spend and funding. mAbs will maintain the lion’s share of the Biologics market, but a variety of novel modalities will continue to grow, effectively complementing the treatment options for patients. From a manufacturing perspective, two trends will likely continue: (i) increasing adoption of intensified processing for a more robust, cost-effective way of producing mAbs without compromising on quality, and (ii) the establishment of new manufacturing templates that are needed to make novel modalities, like viral gene therapies, more broadly accessible.”
Better Vectors – with David Kirn, CEO and Co-Founder, 4DMT
“The biopharmaceutical industry has been shaped by several key disruptors, particularly in the field of genetic medicine. While adeno-associated virus (AAV) vectors have brought genetic medicines to patients with rare and often fatal diseases, the challenges associated with the in vivo delivery of genetic medicine technologies have left many without safe and effective treatment options. Major challenges of AVVs include the need for high doses, expensive manufacturing, and the potential for adverse side effects – such as liver toxicity. Additionally, pre-existing antibodies to conventional vectors limit the utility of these therapies.
“The field needs vectors that are more efficient at transducing specific cell types, and vectors that are more efficiently delivered at low and safe doses by routine routes of administration clinically; simply, we need better vectors. I foresee a shift in the introduction and development of next-generation AAVs using synthetic biology and novel capsids to overcome the limitations of conventional AAVs across the next ten years. One widely recognized approach that could bring superior AAV vectors is directed evolution, which allows humans to create novel bespoke biologics. In the case of AAV, the capsid can be diversified in order to generate billions of potential synthetic AAV capsids. In vivo iterative selection can then be used to identify the synthetic AAV capsid with the best match to the investigator’s target vector profile.
“Though past successes focused predominantly on rare diseases, the industry's gaze now appears set on larger, more complex conditions. As such, we might also expect to see breakthroughs in delivery systems, as enhancements in vector design, transgenes, and immunomodulatory regimens will likely improve delivery efficiency and gene expression, and reduce immunogenicity.”
Log in or register to read this article in full and gain access to The Medicine Maker’s entire content archive. It’s FREE!
Receive content, products, events as well as relevant industry updates from The Medicine Maker and its sponsors.
We asked: What big changes in drug development and manufacturing would you like to see in the next 10 years?
Conjugation and Collaboration – with Seokjin Chang, Senior Director of Market Intelligence, Samsung Biologics
“I would like to see players in the biopharma industry go beyond merely advancing their business goals. This means facilitating more robust partnerships and working as one team to expedite the development/commercialization of novel therapeutics.
“Acknowledging that monoclonal antibodies make up the largest share in the industry and are still the fastest-growing modality in the market, efforts to mitigate side effects while taking chemotherapeutics have long hit roadblocks. The successful clinical result of Daiichi Sankyo’s Enhertu in 2022 has propelled hope that soon such roadblocks can be overcome by developing more types of drug conjugates beyond antibodies. To bring the hope to fruition, industry-wide efforts to leverage conjugation methods to bring about novel therapeutics are well underway.
“For example, Regeneron's AAV conjugation antibody reduces side effects from off-target expression and seeks to deliver AAV to target cells. Such innovative therapeutics can become available if more robust conjugation methods that send payloads to specific cells with little side effects can be developed. I hope to see more rigorous efforts to create pipelines that can conjugate other types of payloads, such as radioactive materials, steroids, and cytotoxic drugs.
“To embolden such efforts, the industry players need to come together and collaborate. ADCs need cutting-edge technologies and advanced facilities. Not all drug developers have such resources available and thus need help. This is why I hope to see more partnerships between drug developers with scientific knowledge and CDMOs with resources in the future, filling each other’s gap and doubling down on our concerted mission for patients.”
