Over the last decades, outsourcing of pharmaceutical development and manufacturing, driven by a variety of factors, has resulted in the growth of Contract Development and Manufacturing Organizations (CDMO).

In the majority of cases, these factors included pharmaceutical companies’ divestment of manufacturing facilities designed to de-risk R&D efforts, the requirement to increase the speed-to-market of novel, life-saving drugs, and the need to reduce the high fixed costs of in-house manufacturing.

Outsourcing has also increased as a result of the growing complexities of novel agents, including antibody-drug conjugates or ADCs.[1] This increasing complexity has created a need for specialty and niche capabilities and competencies that pharmaceutical companies seek to access externally rather than develop these themselves.

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In the development of life-saving drugs, such as ADCs, innovation and speed-to-market are critical. [1] Focusing on their own competencies and improving efficiency, pharmaceutical companies are also consolidating their supplier base, selecting strong partners from a small number of CDMOs that offer dedicated services across a number of novel investigational drugs as well as development and manufacturing. Furthermore, to eliminate the need for excess technology transfer and to serve customers end-to-end, CDMOs continue to grow their abilities to offer reliable integrated services across the entire drug lifecycle. To meet these needs in the area of biologics capabilities and capacity, CDMOs are acquiring existing facilities or are constructing new ones.

With increasing capacity, a growing number of relatively small, specialty and biotech firms rely on the unique expertise of CDMOs to drive their investigational drugs through pre-clinical and clinical development. In many cases, these external collaborations provide the required bandwidth needed to drive drug approvals to a successful launch.

Market growth
In North America, the CDMO market is expected to grow by 6.0% annually in the forecast period of 2021-2025 and reach US $101.1 billion by 2030 driven by increasing demand for biological therapies and specialty medicines, rising demand for cost control in drug development, and rising healthcare expenditures according to New Yorlk-based global market research firm Kenneth Research.

Antibody-drug Conjugates
Combine the selectivity of antibodies with the efficacy of small molecule drugs, allowing for more precise, targeted, therapeutic applications, Antibody-drug Conjugates (ADC) have become a powerful class of agents. However, the arduous history of the development of novel ADCs has shown that these targeted agents will always be far more complex than that of a small-molecule new chemical entity (NCE).

So, how can a CDMO support the development and manufacturing of ADCs?

First and foremost, selecting the right CDMO for an ADC development project is critical. From discovery to early, pre-clinical and clinical development, to commercialization, the development process of a novel ADC can take many years. Hence, it is crucial for drug developers to select a partner that can support such a long-term relationship with a unique set of specific capabilities to help support the clinical and/or commercial development of a novel ADC in order to bring it through the regulatory approval phase and, ultimately, to the patient.

Another key consideration is that throughout the development process, the CDMO/partner focuses on the development of a ‘simple’ design the process (i.e. manufacturing friendly), efficient (i.e. cost-effective), and robust (i.e. scalable, simple tech transfer) and results in a product that is as homogeneous and consistent as possible.  In addition, analytical characterization skills are highly relevant for the design of a better product and process and ensure consistent quality all the way from IND to the commercial scale.

In a recently released video Lisa McDermott, Director, Process, and Analytic Development, at MilliporeSigma, shares how she and her team work with Antibody-drug Conjugates (ADC) innovators to speed the delivery of these promising therapies to patients.

[1] What are Antibody-drug Conjugates? The Review. Online ADC Review | Journal of Antibody-drug Conjugates. Online. Last accessed August 24, 2021

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