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March 2017 Featured Report
Figure 1: Outsourcing market growth — business drivers. CROs = contract research organizations CMOs = contract manufacturing organizations CDMOs = contract development and manufacturing organizations
The analytical field for biologics has evolved greatly over the past 30 years, and the underlying growth has shifted from biopharmaceutical companies to contract research organizations (CROs). The global biopharmaceutical market is growing annually at >15%, making it the largest and consistently fastest growing segment of the healthcare industry with annual sales in excess of US$200 billion. Contract manufacturing organizations (CMOs) are expanding capacity by building new cost-efficient facilities, reflecting market demand. Many product sponsors are outsourcing, some even increasing their outsourced work.
Meanwhile, the pharmaceutical industry is consolidating through acquisitions and mergers as well as forming strategic a...
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As the debate continues over the high cost of pharmaceutical treatment options, the development of biosimilars continues to play a dominant role in that discussion and will be an important part of the solution. Biosimilar companies are working at a feverish pace to develop the next generation of follow-on products. Outsourcing to a growing group of contract development and manufacturing organizations (CDMOs) is a key strategy for savvy developers to accelerate their products’ launch.
Finding the right CDMO isn’t an easy task, however. Cost and capabilities continue to be key factors used to differentiate competitors in a crowded market, but biosimilar companies face a number of unique strategic challenges that must be considered as well. We interviewed companies that are sponsoring biosimilar candidates and CDMOs that manufacture such products to identify some challenges and find out how CDMOs are adapting to capture this portion of the biopharmaceutical market.
Figure 1: Totality of sc...
Expanding biopharmaceutical pipelines and therapeutic modalities are feeding a boom in outsourcing key elements of development and manufacturing projects. The rapid growth of the industry as well as of emerging therapeutic areas (e.g., antibody–drug conjugates, biosimilars) challenge sponsors and contractors alike to meet industry needs.
The authors in this featured report explore increasing complexities of devising long-term business strategies, the importance of choosing between long-term partnerships or one-time/transaction-based projects; the assurance that adequate business support and technical capabilities exist on both sides of the relationships; and the criticality of navigating the uncertainties of working with different quality organizations.
Most of these considerations always have been an element of biopharmaceutical outsourcing, whether to contract research, manufacturing, or the newer types of development and manufacturing organizations (CROs, CMOs, CDMOs). But despite a history of outsourc...
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Technology transfer in pharmaceutical manufacturing most often is mentioned as occurring between two organizations and involving discrete product lifecycle stages: e.g., a sponsor and a contract manufacturer and from development to manufacturing. According to the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use: “The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement” (
1
). Although certain characteristics of technology transfer are preserved during intra- and inter-organization knowledge hand-offs, here I specifically address the latter.
With outsourcing and contract manufacturing well-established in the commercialization strategies of most pharmaceu...
Managing just the conjugation part of an antibody–drug conjugate (ADC) project can be a challenge. So when you consider all the component parts of an ADC, it is understandable why so many related activities are outsourced.
At Piramal Grangemouth, we provide conjugation development and manufacturing services. Together with our sister sites in the United States and United Kingdom, we offer payload manufacture and fill–finish capability. The Grangemouth (UK) site has been involved in ADC conjugation services now for over 13 years. Within that time frame, the company has delivered projects across all key chemistry platforms, worked with more than 100 monoclonal antibodies (MAbs), more than 50 drug linkers, and more than 30 products under good manufacturing practices (GMPs).
We have certainly seen that ADC manufacturers don’t have it easy. They have to consider production of antibody and drug (linker), ADC conjugation, and ADC fill–finish — as well as the toxicological and clinical aspects. Development activit...
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