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Manufacture Bioprocessing - Upstream & Downstream, Trends & Forecasts

The Era of Antibody 2.0

What we asked: “Looking ahead to the next 5–10 years, what will be the key disruptors and/or what can be improved upon in the pharma industry?”

Response from: 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.

Response from: Jeng Her, CEO, AP Biosciences

We’ve witnessed antibody-based therapeutics transform the treatment landscape for patients across autoimmune disease, infectious disease, and especially cancer. Monoclonal antibodies have drastically improved patient outcomes in oncology and become the backbone for a range of therapeutic strategies. Their ability to bind specific targets continues to offer near limitless applications across drug development.

We’re now entering the “antibody 2.0” era, wherein the field has begun to overcome the initial limitations of antibody-based therapeutics, such as efficacy and resistance. We’ve seen the adoption of new strategies in the form of antibody-conjugates, which are quickly becoming the norm, and now bispecific antibodies are emerging as another breakthrough drug class. These drugs can function as a combination treatment in a single molecule, simultaneously reducing toxicities associated with multidrug regimens and decreasing the likelihood of resistance. The high specificity of bispecifics can be combined not only with ADCs, but an array of other treatment modalities to enhance on-target activity and reduce side effects. The incredible flexibility of this approach is already creating new therapeutic strategies and improving on existing approaches.

With the growing number of applications, I foresee a concurrent rise in investment and collaboration aimed at streamlining antibody design and manufacturing, enabling us to treat patients with safer, more potent therapeutics.

Read over 100 other views on the future of the pharma industry on our special web page.

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