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Contract manufacturing organization

From Wikipedia, the free encyclopedia

Acontract manufacturing organization(CMO), more recently referred to (and more commonly used now) as acontract development and manufacturing organization(CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organization in the pharma industry, is acompanythat serves other companies in thepharmaceutical industryon acontractbasis to provide comprehensive services fromdrug developmentthroughdrug manufacturing.[1]This allows major pharmaceutical companies tooutsourcethose aspects of the business, which can help withscalabilityor can allow the major company to focus ondrug discoveryanddrug marketinginstead.

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

  • pre-formulation,
  • formulationdevelopment,
  • stability studies,
  • method development,
  • pre-clinical and Phase Iclinical trialmaterials,
  • late-stage clinical trial materials,
  • formal stability,
  • scale-up,
  • registration batches and commercial production.

CDMOs arecontract 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 withgood manufacturing practicefrom their client and regulatory bodies such asFood and Drug Administration.[2]

Overview

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The pharmaceutical market uses outsourcing services from providers in the form ofcontract 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

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Before thefinancial 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 byprivate equityas 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 themergers and acquisitionsin 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,Pfizerestablished a manufacturing site inLiscate, Italy,which was followed that same year byAstraZenecainReims, France.[9][10][11][12][13][14]Novartis Sandozacquired a site inBoucherville, Canadain 2018, as well asGlaxo Smith Kline,which began manufacturing out ofSouth Carolinain theUnited States.[15][16][17][18][19][20][21][22]Samsung Biologicsbuilt 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

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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 inPhase 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

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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 securitycan be an issue when considering a CDMO, asintellectual propertyand other proprietarydataare 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 anFDA warning letteris 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 theFood and Drug Administration(e.g.:Center for Biologics Evaluation and ResearchorCenter for Drug Evaluation and Research).[2]

See also

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References

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  1. ^Contract Pharma.Contract Pharma. Retrieved on 2013-09-18.
  2. ^ab"CMOs – Speeding Biopharmaceutical Development".BioProcess International.2015-08-24.Retrieved2018-09-18.
  3. ^Taylor, Phil. “Outsourcing of production gaining pace in big pharma” ([1]), 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?” ([2]), Contract Pharma, March 2008:70–74. Retrieved 7-3-08.
  5. ^Miller, Jim."Sizing Up the CDMO Market".www.pharmtech.com.Retrieved2018-09-20.
  6. ^ab"The golden age of the CDMO: a retrospective with Jim Miller – Pharmaceutical Technology".Pharmaceutical Technology.2018-05-08.Retrieved2018-09-18.
  7. ^"From CMO to CDMO: Opportunities for Specializing and Innovation – BioProcess International".BioProcess International.2016-05-17.Retrieved2018-09-20.
  8. ^abMiller, Jim."CDMO Acquisitions Build Strategic Supplier Base".www.biopharminternational.com.Retrieved2018-09-18.
  9. ^Insight, Nice."Avara Pharmaceutical Services acquires Sterile facility from Pfizer in Italy".Archived fromthe originalon 2018-09-18.Retrieved2018-09-18.
  10. ^"Avara Acquires Sterile Facility from Pfizer in Italy".Contract Pharma.Retrieved2018-09-18.
  11. ^"Avara Acquires Sterile Facility From Pfizer In Italy | BioSpace".BioSpace.Retrieved2018-09-18.
  12. ^"Avara Acquires Secondary Solid Dosage Form Manufacturing, Packaging And Distribution Facility From AstraZeneca PLC In France | BioSpace".BioSpace.Retrieved2018-09-18.
  13. ^"Avara Acquires AstraZeneca Facility in France".Contract Pharma.Retrieved2018-09-18.
  14. ^"Avara Pharmaceutical buys AstraZeneca's Reims solid dosage facility – Pharmaceutical Technology".Pharmaceutical Technology.2017-10-09.Retrieved2018-09-18.
  15. ^"Avara Pharmaceutical to buy Novartis's production plant in Canada".Pharmaceutical Technology.2018-05-29.Retrieved2018-09-18.
  16. ^"Avara Acquires Sterile Mfg. Facility in Canada".Contract Pharma.Retrieved2018-09-18.
  17. ^"Avara Pharmaceutical Services Acquires Major Sterile Manufacturing Facility and Development Center in Canada | BioSpace".BioSpace.Retrieved2018-09-18.
  18. ^Insight, Nice."Avara Pharmaceutical Services Acquires Major Sterile Manufacturing Facility and Development Center in Canada".Archived fromthe originalon 2018-09-18.Retrieved2018-09-18.
  19. ^Insight, Nice."Avara Pharmaceutical Services Finalizes Acquisition of GSK Secondary Manufacturing and Packaging Facility in South Carolina".Archived fromthe originalon 2018-09-18.Retrieved2018-09-18.
  20. ^"Avara Acquires GSK Facility".Contract Pharma.Retrieved2018-09-18.
  21. ^"Avara Pharmaceutical Services Finalizes Acquisition of GSK Consumer Healthcare facility in South Carolina | BioSpace".BioSpace.Retrieved2018-09-18.
  22. ^Insight, Nice."Avara Acquires New OTC Solid Dose Capacity in South Carolina".Archived fromthe originalon 2018-09-18.Retrieved2018-09-18.
  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.RetrievedNovember 16,2016.
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