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Exponential Growth Expected for Antibody-drug Conjugates (ADCs) – CDMOs Continue to Play a Major Role in Manufacturing and Co-Development

A survey by the publishers of ADC Review | Journal of Antibody-drug Conjugates showed that in 2017 the global market for antibody therapies reached U.S. $ 4 billion. Approximately forty-five percent of this market included Antibody-drug Conjugates (ADCs). However, in the next few years the market for novel antibody therapies (including ADCs) is expected to grow significantly, to U.S. $ 17 billion by 2023. [1][2][3]

In addition to this exponential growth, the survey also confirmed an ongoing trend of outsourcing manufacturing and/or co-development to integrated Contract Development Manufacturing Organizations (CDMOs). As a result, the survey showed, many CDMOs are expanding their market share.

To optimize costs, major pharmaceutical companies continue to shed manufacturing assets, driving the need to access specialized capabilities designed to accelerate the commercialization of complex drug candidates such as Antibody-drug Conjugates. In turn, demand for CDMOs with biologics development, manufacturing and regulatory expertise is strong and growing, leading to substantial new investment by these specialized companies.

With approximately 70% to 80% of all ADC manufacturing conducted by CDMOs, major pharmaceutical companies involved in the development of ADCs, including Genentech/Roche, Pfizer, Sanofi, Daiichi Sankyo, Takeda and Seattle Genetics either outsource manufacturing of their ADCs, collaborate with a CDMO in a co-development model or are doing so in the near future. Other companies, including companies like ImmunoGen, have recently shifted their ADC manufacturing to an outsourcing model, saving both time and money.[3]

Manufacturing Challenge
The manufacturing of Antibody-drug Conjugates is complex and requires a cGMP facility designed with the proper engineering controls to provide product and personnel protection from highly potent compounds. This includes, for example, isolators being operated at containment Category 4 designated as Safebridge® to cope with very low occupational exposure limit (OEL). For ADC fill-finish, a fill line with lyophilization capability enclosed in a separate isolator is an additional requirement.

“Contract Development Manufacturing Organizations offer specific technical expertise,” says Bethanne Deuel, MBA, Director of Marketing and Alliances at MabPlex International, a CDMO which specializes in the development and cGMP manufacturing of recombinant proteins, antibody therapeutics and Antibody-drug Conjugates for its global customers.

“Working with an integrated CDMO like MabPlex reduces the time to market because we’re specialized to perform all key manufacturing steps, from initial R&D through commercial manufacturing and fill-finish. This saves our customers a considerable amount of time and money,” Deuel added.

“What’s so unique in working with a CDMO like MabPlex is that we have the necessary technological and regulatory expertise, often more than our clients,” she concluded.

Currently approved ADCs
Today, there are 4 approved and commercially available ADCs, including Brentuximab vedotin (Adcetris®; Seattle Genetics); Ado-trastuzumab entansine (Kadcyla®; Genetech/Roche); Inotuzumab ozogamicin (Besponsa™, Wyeth Pharmaceuticals, a subsidiary of Pfizer) and Gemtuzumab ozogamicin (Mylotarg™; Wyeth Pharmaceuticals, a subsidiary of Pfizer).

The development these agents has allowed for a more targeted and tumor-specific therapy rather than a non-specific cytolytic chemotherapy or radiation therapy. [4]

Building on their experience, researchers experienced in protein engineering and medicinal chemistry continue to advance these drugs as important therapeutic modalities, both as single agents and as part of various combination regimens with immunotherapeutic agents such as checkpoint inhibitors. And with a large number of Antibody-drug Conjugates in late stage clinical development, the expectation is that, in the next 18 - 24 months, the number of approved and commercially available ADCs will grow exponentially. [5]

What are Antibody-drug Conjugates?
Antibody-drug conjugates (ADC) are a class of innovative and highly potent biopharmaceutical drugs composed of a monoclonal antibody linked, via a chemical linker, to a biologically active drug or cytotoxic (anti-cancer) compound. Often referred to as payload, these cytotoxic agents are designed to induce target cell death when internalized (into the target cell) and released.

By combining the unique and very sensitive targeting capabilities of monoclonal antibodies with the cell-killing ability of their payloads, ADCs are able to deliver highly cytotoxic drug directly to targeted cancer cells without causing 'collateral damage' to 'normal' or 'healthy' cells. As a result, ADCs are designed to overcome the disadvantages of conventional pharmacotherapy based on cytotoxic or immunomodulatory drug, which are not specific to tumor cells, affect normal cells, and may lead to life-threatening side effects.

Although the concept of Antibody-drug Conjugates seems relatively simple, designing a successful, clinically effective, ADCs is complex, requiring careful selection of the receptor antigen, monoclonal antibody, linker chemistry, and cytotoxic payload.

About ADC Review | Journal of Antibody-drug Conjugates
Launched in the summer of 2013 ADC Review | J. of Antibody-drug Conjugates (ISSN 2327-0152) is an international, hybrid open-access, peer reviewed journal designed to serve the needs of a diverse community of individuals involved with the (early) discovery, development, clinical research, manufacturing and legal and regulatory aspects of Antibody-drug Conjugates. The purpose of the Journal is to present relevant information in an understandable and useful format to all stakeholders.[5]

Guided by an Advisory and Editorial Board comprised of scientists, physicians and industry experts/Key Opinion Leaders (KOL) and legal/regulatory experts from a broad range of backgrounds and expertise, the Journal includes news, resources, editorials, and peer reviewed articles.

Recently published peer reviewed articles include a review of progress made in the development of Antibody-drug Conjugates (ADCs – The Dawn of a New Era?), an overview of what we can expect from future developments (ADCs – Look Forward to a Potent Future) and a patent related discussion about Nonobviousness of ADC Inventions.

New Networking Tool: ADC Directory
In addition to the online Journal, the publishers of ADC Review | Journal of Antibody-drug Conjugates recently launched a new networking tool: ADC Directory. The ADC Directory provides a seamless exchange of information between businesses and professionals focused on the research, development and manufacture of antibody-drug conjugates. Members have the opportunity to share reviews, articles, videos, events, products, career opportunities and much more.

About MabPlex International
MabPlex provides global CDMO services in the development and manufacturing of biopharmaceuticals, including mAbs, recombinant proteins, ADCs and bispecifics. The companies offer its partners contract services from DNA to finished drug product. MabPlex technical expertise allows the company to provide effective high quality solutions for its partner's biomanufacturing needs. At both its R&D site in the United States and the manufacturing site in Yantai, China, MabPlex is commitment to partners through the quality of manufacturing, meeting and exceeding their expectations.

Conference Coverage
During the upcoming 9th Annual World ADC Conference, held in the Marriott Marquis & Marina, San Diego, California, November 12 - 15, 2018, one of the best learning experiences in the industry and an ideal forum to stay up to date with the latest developments and progress made in the area of ADCs as well as the opportunity to meet experts, editors of ADC Review | Journal of Antibody-drug Conjugates will be on site for interviews and more. [6]

For more information, or content of which is not part of this press release, please visit ADC Review | Journal of Antibody-drug Conjugates ADC Directory. Contact our business development team for more information about sponsoring and underwriting.

Editorial Office | 4960 South Gilbert Rd, Suite 1-286, Chandler, AZ 85249 (USA)

[1] ADC Review | J. Antibody-drug Conjugates | Drug Map Online. Last Accessed November 12, 2018
[2] Contract Manufacturing of Antibody-drug Conjugates – A Growing Market. ADC Review | J. of Antibody-drug Conjugates. February 22, 2016. Last Accessed November 12, 2018
[3] CPhI Annual Industry Report 2018: Expert Contribution. Online. Last Accessed November 12, 2018
[4] The Expanding Field of Antibody-Drug Conjugates. Online ADC Review | J. of Antibody-drug Conjugates January 19, 2018. Last Accessed November 12, 2018.
[5] How do ADCs Work. J. of Antibody-drug Conjugates. Last Accessed November 12, 2018
[6] 9th World ADC San Diego: What to Expect. Last Accessed November 12, 2018

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