Emerging antibody-based products for infectious diseases: Planning for metric ton manufacturing

Abstract

This review focuses on the emerging monoclonal antibody market for infectious diseases and the metric ton scale manufacturing requirements to meet global demand. Increasing access to existing antibodybased products coupled with the unmet need in infectious disease will likely exceed the current existing global manufacturing capacity. Further, the large numbers of individuals infected during epidemics such as the ongoing COVID-19 pandemic emphasizes the need to plan for metric ton manufacturing of monoclonal antibodies by expanding infrastructure and exploring alternative production systems.

Mapping monoclonal anti-SARS-CoV-2 antibody repertoires against diverse coronavirus antigens

“…For the treatment of the disease, one small molecule antiviral drug (remdesivir) has been approved by the FDA, and Emergency Use Authorizations (EUAs) have been issued to two other drug treatments (nirmatrelvir+ritonavir, and molnupiravir) and to two monoclonal antibodies (mAbs) -Evusheld and Bebtelovimab (32-36). Before the COVID-19 pandemic, only two monoclonal antibodies had received approval from the FDA for the treatment of infectious diseases: palivizumab targeting respiratory syncytial virus (RSV), and ibalizumab to treat HIV infection (37)(38)(39). Many therapeutic monoclonal antibodies against COVID-19 neutralize SARS-CoV-2 infection by binding to the viral Spike glycoprotein and preventing the interaction between the SARS-CoV-2 and its entry receptor, angiotensin-converting enzyme 2 (ACE2) (40, 41).…”

Special focus issue: passive immunization

“…16 Kevin Whaley and myself review some of the challenges with meeting manufacturing scales in order to ensure global access to future potential anti-infective mAbs. 17 …”

“…An overall aim of this section of the Special Focus Issue is to highlight the great potential for rapid advances in mucosal therapy and prophylaxis now that monoclonal antibodies have become significantly less costly to manufacture. 17 …”

High‐density adherent culture of CHO cells using rolled scaffold bioreactor

“…Therapeutic monoclonal antibodies claim more than half of the sales since 2012 (Grilo & Mantalaris, 2019), and their sales alone are expected to reach $300 billion by 2025 (Lu et al, 2020). Mammalian cells are currently the most dominant expression platform of therapeutic proteins (Ecker & Seymour, 2020;Whaley & Zeitlin, 2021), and there is a strong need to streamline the large-scale culture of these cells.…”

“…Therapeutic monoclonal antibodies claim more than half of the sales since 2012 (Grilo & Mantalaris, 2019), and their sales alone are expected to reach $300 billion by 2025 (Lu et al, 2020). Mammalian cells are currently the most dominant expression platform of therapeutic proteins (Ecker & Seymour, 2020; Whaley & Zeitlin, 2021), and there is a strong need to streamline the large‐scale culture of these cells. To this end, the biopharmaceutical industry actively seeks bioreactors that can culture mammalian cells with larger capacity, higher efficiency and reliability, reduced production cost, and shorter commercialization period (Karst et al, 2018; Walker, 2017).…”