Contract manufacturing organization

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A contract manufacturing organization (CMO), more recently referred to (and more commonly used now) as a contract development and manufacturing organization (CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organization in the pharma industry, is a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive services from drug development through drug manufacturing. [1] This allows major pharmaceutical companies to outsource those aspects of the business, which can help with scalability or can allow the major company to focus on drug discovery and drug marketing instead.

Contents

Services offered by CDMOs include, but are not limited to:

CDMOs are contract manufacturers, yet they provide development as a standard part of their services.

Their customers are not only expecting competitive pricing, but also regulatory compliance, flexibility on the production capability and on time delivery. Overall it is required that CMO complies with good manufacturing practice from their client and regulatory bodies such as Food and Drug Administration. [2]

Overview

The pharmaceutical market uses outsourcing services from providers in the form of contract research organizations (CROs) who work on very early-stage drug development on very small scale providing medicinal chemistry services. These are now often called CDROs as they provide some small scale development work. CDMOs work on the scale-up and later stages of drug development often preparing materials ranging from hundreds of grams to multi-kilo amounts. As the drug moves through the various clinical stages, the volumes tend to grow as well. Commercial scale amounts could range to metric tons. Over the years, the concept of a comprehensive single-source provider from drug development (a one-stop shop) through commercial manufacture of drug substance and drug product has been tried to varying success.

CDMOs are a response to the competitive international nature of the pharmaceutical market as well as the increasing demand for outsourced services. [3] The best-positioned service providers focus on a specific technology or dosage form and promote end-to-end continuity and efficiency for their outsourcing clients. With lower-cost international manufacturers capturing an increasing percentage of the contract manufacturing market, specialization may be an effective hedge against loss of market share. [4]

History

Before the financial crisis of 2007–2008, 75% of the candidate that outsourced services were small and mid-sized biotechnology and pharmaceutical companies. [5] Following the financial crash in 2008 the CMO industry started to be funded by private equity as a result of a substantial growth and a more qualified management. [6] The one-stop CDMO concept could be the direction the industry is heading by offering the whole spectrum of development services (e.g. development, production and analysis). [7]

The acquisitions that have been finalized in 2017 in CMO and CDMO industry brought some of these companies to a level that allows them to compete with global bio/pharma companies. The value of the mergers and acquisitions in 2017 was likely to exceed $20 billion, below are some examples of these M&A: [8]

Another aspect of these acquisition is coming from CMO that are acquiring manufacturing site from bio/pharma companies. In 2017, Pfizer established a manufacturing site in Liscate, Italy, which was followed that same year by AstraZeneca in Reims, France. [9] [10] [11] [12] [13] [14] Novartis Sandoz acquired a site in Boucherville, Canada in 2018, as well as Glaxo Smith Kline, which began manufacturing out of South Carolina in the United States. [15] [16] [17] [18] [19] [20] [21] [22] Samsung Biologics built three manufacturing plants with a capacity of more than 360,000 liters, making it the world's largest contract-based manufacturer in the biopharmaceutical sector at a single site as of 2018. [23] [24]

The industry has experienced an increase in private equity investment and this has led to the consolidation of choices in the CDMO industry as many larger CDMOs have been formed. Many of those are active at aiming to be a larger scale suppliers in the CDMO environment but the number of attractive acquisitions are limited. [8] One could argue that this has had both positive and negative effects on the industry. Larger pharma companies like the idea of a larger CDMO while smaller pharma companies tend to see it more difficult to get the kind of service they expect.

Advantages

The bio/pharma companies used to build and staff dedicated manufacturing capacities for drugs in development only to see them cancelled if the product failed in Phase III of clinical research; working with a CDMO limits that financial risk. [6] [25] Using a CDMO also allows drug and biologic manufacturers to get advantage of specific expertise and capability. Some CDMOs are specialized in manufacturing of specialty products or formulations which some pharmaceutical companies may not have the capability to produce in house. In these situations, contracting with a CDMO may be a faster and less costly solution than developing new manufacturing capabilities.

Disadvantages

The pharmaceutical client using the services of a CDMO does not have direct control of the project in regard to scheduling, cost, quality, or accountability yet should be heavily invested to work closely with the CDMO partner to ensure success. Data security can be an issue when considering a CDMO, as intellectual property and other proprietary data are exchanged between client and service provider.

One of the major risk remains in the lack of control over the CDMO's compliance for the client, for example when an FDA warning letter is issued, a resulting interruption of production may result in major delay or interruption of shipping thus it is critical to properly vet the selected CDMO. The rise of the CDMO industry led to an increase of inspectors from various divisions of the Food and Drug Administration (e.g.: Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research). [2]

See also

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<span class="mw-page-title-main">Pfizer</span> American multinational pharmaceutical and biotechnology corporation

Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered at The Spiral in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer (1824–1906) and his cousin Charles F. Erhart (1821–1891).

<span class="mw-page-title-main">AstraZeneca</span> British pharmaceutical company

AstraZeneca plc is an Anglo-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas including oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation. It has been involved in developing the Oxford–AstraZeneca COVID-19 vaccine.

The Merck Group, branded and commonly known as Merck, is a German multinational science and technology company headquartered in Darmstadt, with about 60,000 employees and a presence in 66 countries. The group includes around 250 companies; the main company is Merck KGaA in Germany. The company is divided into three business lines: Healthcare, Life Sciences and Electronics. Merck was founded in 1668 and is the world's oldest operating chemical and pharmaceutical company, as well as one of the largest pharmaceutical companies globally.

<span class="mw-page-title-main">Labcorp Drug Development</span> Contract research organization

Labcorp Drug Development is a contract research organization (CRO) headquartered in Burlington, North Carolina, providing nonclinical, preclinical, clinical and commercialization services to pharmaceutical and biotechnology industries. Formerly called Covance, the company is part of Labcorp, which employs more than 70,000 people worldwide. Labcorp Drug Development claims to provide the world's largest central laboratory network.

In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biological assay development, commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research, and real world evidence.

Charles River Laboratories International, Inc., is an American pharmaceutical company specializing in a variety of preclinical and clinical laboratory, gene therapy and cell therapy services for the Pharmaceutical, Medical device and Biotechnology industries. It also supplies assorted biomedical products, outsourcing services, and animals for research and development in the pharmaceutical industry and offers support in the fields of basic research, drug discovery, safety and efficacy, clinical support, and manufacturing.

Parexel International is an American provider of biopharmaceutical services. It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process. It is the second largest clinical research organization in the world and has helped develop approximately 95% of the 200 top-selling biopharmaceuticals on the market today. The company publishes the annual Parexel R&D Statistical Sourcebook, operates the Parexel-Academy, and councils all of the top 50 biopharmaceutical and top 30 biotechnology companies.

<span class="mw-page-title-main">Cambrex Corporation</span> American pharmaceutical company

Cambrex Corporation is a Contract Development Manufacturing Organisation (CDMO) that provides drug substance, drug product and analytical services across the entire drug lifecycle, as well as active pharmaceutical ingredients (APIs). With over 2,200 employees in 7 countries across 13 locations, Cambrex operates in branded and generic markets for API and dosage form development and manufacturing.

<span class="mw-page-title-main">Patheon</span>

Patheon is a service brand within Thermo Fisher Scientific’s brand portfolio. Contract development and manufacturing organization (CDMO) services offered under the Patheon brand include small molecule API, biologics, viral vectors, cGMP plasmids, formulation, clinical trials solutions, logistics and commercial manufacturing and packaging. In 2017, Patheon was acquired by Thermo Fisher Scientific to form its Pharma Services business.

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<span class="mw-page-title-main">Therapure BioPharma Inc</span>

Therapure BioPharma, Inc. is a Canadian biopharmaceutical industry and biotechnology company, headquartered in Mississauga, Ontario, a privately held, integrated Contract Development and Manufacturing Organization (CDMO). Founded in 2008, the firm provides a range of therapeutic protein development and manufacturing services including; technology transfer & process development, analytical development and testing, scale up and cGMP manufacturing, and aseptic fill/finish and lyophilization. As of 2010, the company has over 90 employees. In 2020, Therapure was acquired by Resilience.

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Dishman Carbogen Amcis Ltd is an Indian multinational pharmaceutical company specialized in the manufacture of active ingredients and contract development and manufacturing. Dishman employs over 1,000 people worldwide and is listed on the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE).

AMRI is a contract research and manufacturing organization that provides drug discovery, development, cGMP manufacturing and aseptic fill and finish to the pharmaceutical and biotechnology industries. Founded in 1991, AMRI operates in the United States, Europe and Asia, with its headquarters located in Albany, New York. AMRI has announced deals and collaborations with such companies as Pfizer Inc., Merck & Co., Eli Lilly and Co., Takeda, Genentech, Bristol-Myers Squibb Co. and GE.

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References

  1. ↑ Contract Pharma. Contract Pharma. Retrieved on 2013-09-18.
  2. 1 2 "CMOs – Speeding Biopharmaceutical Development". BioProcess International. 2015-08-24. Retrieved 2018-09-18.
  3. ↑ Taylor, Phil. “Outsourcing of production gaining pace in big pharma” (), Outsourcing Pharma.com, May 27, 2008. Retrieved 7-3-08.
  4. ↑ Spurgeon, Tom. “Continuity and Connectivity: We Can Do That, Too” “(subtitle) Are CDMOs the Next Big Thing?” (), Contract Pharma, March 2008:70–74. Retrieved 7-3-08.
  5. ↑ Miller, Jim. "Sizing Up the CDMO Market". www.pharmtech.com. Retrieved 2018-09-20.
  6. 1 2 "The golden age of the CDMO: a retrospective with Jim Miller – Pharmaceutical Technology". Pharmaceutical Technology. 2018-05-08. Retrieved 2018-09-18.
  7. ↑ "From CMO to CDMO: Opportunities for Specializing and Innovation – BioProcess International". BioProcess International. 2016-05-17. Retrieved 2018-09-20.
  8. 1 2 Miller, Jim. "CDMO Acquisitions Build Strategic Supplier Base". www.biopharminternational.com. Retrieved 2018-09-18.
  9. ↑ Insight, Nice. "Avara Pharmaceutical Services acquires Sterile facility from Pfizer in Italy". Archived from the original on 2018-09-18. Retrieved 2018-09-18.
  10. ↑ "Avara Acquires Sterile Facility from Pfizer in Italy". Contract Pharma. Retrieved 2018-09-18.
  11. ↑ "Avara Acquires Sterile Facility From Pfizer In Italy | BioSpace". BioSpace. Retrieved 2018-09-18.
  12. ↑ "Avara Acquires Secondary Solid Dosage Form Manufacturing, Packaging And Distribution Facility From AstraZeneca PLC In France | BioSpace". BioSpace. Retrieved 2018-09-18.
  13. ↑ "Avara Acquires AstraZeneca Facility in France". Contract Pharma. Retrieved 2018-09-18.
  14. ↑ "Avara Pharmaceutical buys AstraZeneca's Reims solid dosage facility – Pharmaceutical Technology". Pharmaceutical Technology. 2017-10-09. Retrieved 2018-09-18.
  15. ↑ "Avara Pharmaceutical to buy Novartis's production plant in Canada". Pharmaceutical Technology. 2018-05-29. Retrieved 2018-09-18.
  16. ↑ "Avara Acquires Sterile Mfg. Facility in Canada". Contract Pharma. Retrieved 2018-09-18.
  17. ↑ "Avara Pharmaceutical Services Acquires Major Sterile Manufacturing Facility and Development Center in Canada | BioSpace". BioSpace. Retrieved 2018-09-18.
  18. ↑ Insight, Nice. "Avara Pharmaceutical Services Acquires Major Sterile Manufacturing Facility and Development Center in Canada". Archived from the original on 2018-09-18. Retrieved 2018-09-18.
  19. ↑ Insight, Nice. "Avara Pharmaceutical Services Finalizes Acquisition of GSK Secondary Manufacturing and Packaging Facility in South Carolina". Archived from the original on 2018-09-18. Retrieved 2018-09-18.
  20. ↑ "Avara Acquires GSK Facility". Contract Pharma. Retrieved 2018-09-18.
  21. ↑ "Avara Pharmaceutical Services Finalizes Acquisition of GSK Consumer Healthcare facility in South Carolina | BioSpace". BioSpace. Retrieved 2018-09-18.
  22. ↑ Insight, Nice. "Avara Acquires New OTC Solid Dose Capacity in South Carolina". Archived from the original on 2018-09-18. Retrieved 2018-09-18.
  23. ↑ "Samsung BioLogics annual sales up 30% on contract research growth". Korea Biomedical Review.
  24. ↑ "Samsung Biologics to add new contract drug-making plant". The Korea Times.
  25. ↑ "Two-thirds of pharmaceutical manufacturing is outsourced; preferred providers pick up largest share". Pharmaceutical Processing. Retrieved November 16, 2016.
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