The role of outsourcing in antibody drug manufacture

A study investigating the trend for existing pharmaceutical companies to outsource to contracted development and manufacturing organisations (CDMOs), analysing the position of companies manufacturing monoclonal antibody drugs (mAbs).

Yoshiura et al. stated that when conventional small-molecule compounds were the norm within the industry, closed innovation was standard practise and pharmaceutical companies did R&D in-house.

Current “rapid” development of new biotechnological modalities like antibody drugs, means that open innovation beyond a company itself is necessary for continued value in the market, the authors remarked.

With R&D productivity for new drugs “declining”, the sector has shifted to external collaboration via approaches such as acquisitions, the paper explained.

Overcoming obstacles in the manufacture of monoclonal antibody drugs

A lack of manufacturing capacity was highlighted as a major problem in the early development of mAbs for dedicated biotech firms. CDMOs are likely to have helped in overcoming the issue, the authors reported.

In helping overcoming this challenge, the authors noted that CDMOs expanded their partnerships with existing pharmaceutical companies and worked to acquire capabilities separate to manufacturing.

Research highlighted in the paper described that while dedicated biotech firms without manufacturing facilities can initiate clinical trials, along the process it is necessary to develop “appropriate manufacturing and marketing strategies”. The authors shared that this was also the case for investing in external partners via opportunities such as alliances.

The high expense of building manufacturing facilities for monoclonal antibody drugs was also noted as deciding factor for companies choosing to outsource. This is because it presents a major risk for firms in owning their sites, according to the authors. Thus, they emphasised that it is important to mitigate this “by outsourcing manufacturing to CDMOs until the application and launch of the product”.

Other factors were listed related to the development process of inter-organisational collaboration networks in the R&D of mAbs. Findings included: “the size and complexity of the collaborative network continuously increased as dedicated biotech firms established new partnerships with existing pharmaceutical companies”.

Increased outsourcing activity

A survey conducted by the authors indicated that the role of CDMOs in the mAbs industry has changed since 2010, approximately.

Until 2010, contract manufacturing arrangements were for contract manufacturing (drug-manufacturing/supply) of antibody drugs. Yet from 2011, these arrangements were the subject of “patent-non- exclusive rights, technology- exclusive rights and technology-supply”.

Since 2010, some of the contracts for clinical development can be identified as being outsourced by existing mega pharma companies, the authors stated.

Furthermore, the authors shared an analysis which demonstrated a “yearly increase in contracts between companies for outsourcing mAbs production to CDMOs”.

The year 2020 saw a rapid rise in contracts “with the addition of the number of outsourced contracts for the rapid manufacturing of COVID-19 therapeutic mAbs”.

Yoshiura et al. noted that based on this analysis, approximately 20 percent of the total number of mAbs launched in 2020. Yoshiura et al. acknowledged that these results confirm that CDMOs have had an “important role in the development process of mAbs”.

The authors continued, explaining the likely reason for this is because CDMOs have developed and internalised key technologies for manufacturing and development mAbs, via technology platforms.

Findings from the study “will help to understand the innovation process not only in mAbs, but also in diverse new modalities,” the paper concluded.

The paper by Yoshiura et al. is a pre-print published by Research Square.