Choosing the right contract development and manufacturing organization (CDMO) can be a daunting task and your selection can result in a successful, highly beneficial long-term relationship or a waste of time and money. With CDMOs offering support from discovery to commercialization, you’ll want to consider the requirements of your particular project and how your needs may evolve. Partnering with an organization that can fulfill and adapt to those needs can be a huge advantage to getting your life-changing drug to market and to patients. In addition to cost, there are several characteristics you should consider when evaluating a CDMO as a partner for your project.
Key Characteristics to Evaluate when Selecting your CDMO
Technical Capability
To support end-to-end clinical and commercial development of a drug or medical product, capabilities and equipment specific to the industry/niche, application, and scale are required. The initial question to ask is: Can the CDMO make what you need at the required scale? it can be beneficial to work with an organization that has a full range of manufacturing for the dosage forms required and the capacity for multiple scales – from clinical trials to commercial. This can avoid using multiple vendors where technology transfer can cause delays.
Inquire if all facilities are fully owned and if there are complementary core competencies to in-house or other manufacturing contractors. This can help minimize delays due to unanticipated logistics disruptions, provide flexibility to adapt to your needs, and reflect comprehensive support for different facets of your development needs.
Does the facility have the most up-to-date manufacturing technologies and are they known to offer innovative solutions? Modern equipment may offer automated processes or a wider range of customizable parameters that could streamline your project and deliver the quality needed with current industry and regulatory standards.
Capacity
CDMOs of all sizes are now capable of transitioning products from clinical trials through commercialization by consolidating their capabilities through mergers and acquisitions or by partnering with other manufacturers. Having diverse capacity capabilities facilitates long-term partnerships and enables the CDMO to fully understand the complexities of your product to immediately implement proper conditions and streamline development and manufacturing through all phases.
Experience & Expertise
One of the greatest benefits of partnering with a CDMO is access to particular areas of expertise pharmaceutical companies lack in-house. While many outsourcing partners offer services for diverse needs – APIs, small molecules, biologics, pre-filled syringes, etc. – and try to have expertise in many disciplines, selecting an organization with a history of success and strong reputation in your specific area should be a top priority.
Your product is unique and to get to market as quickly as possible, you need an experienced partner that can smoothly scale up manufacturing; is equipped with scientific knowledge and innovative solutions to get past technical barriers; and has highly skilled employees that are familiar with your class of technology, the relevant regulatory landscape, and all development and manufacturing nuances.
Quality
U.S. regulators have strict manufacturing standards that will continue to evolve as new classes of drugs emerge and as technology progresses. Partnering with a CDMO that has a reputation of getting it right the first time will avoid costly delays. Seek a partner that consistently meets quality performance metrics, offers robust regulatory support, and is transparent and proactive with contingency planning and risk management.
Reputation & Reliability
There is no substitute for consistently delivering a high-quality product on schedule. Expansions and investments in cutting-edge technology often indicate a reliable, long-standing outsourcing partner as successful relationships result in growth and the need to increase technical capabilities to support long-term partnerships and future demand. Additionally, partnering with an organization demonstrating exceptional project management with constant communication is beneficial as they will update you on progress, giving you confidence that the project will be completed on time. Similar to evaluating quality, up-front contingency planning and risk management are characteristic of reputable CDMOs.
Service Continuity
End-to-end development and manufacturing services within a single CDMO provides seamless project management and transitions between project phases, while enabling thorough understanding of deliverables and technology and avoiding delays and loss of knowledge. Many CDMOs are marketing themselves as one-stop shop solutions, offering long-term partnerships from discovery to research and development through commercialization and marketing authorizations. CDMOs with differentiated service continuity may offer process development and optimization, analytical services, including stability and storage testing, preformulation and formulation support, and regulatory support in addition to standard development and manufacturing services.
Providing comprehensive services eliminates the need for numerous vendors on a single project, which enhances communication, project management, and speed to market – boosting the return on investment.
Culture Fit & Client Management
It takes several years to develop a drug, requiring long-term partnerships between CDMOs and pharmaceutical companies. Finding a partner that complements or enhances your core competencies and has accessible senior management is imperative to a successful relationship. Additionally, timely project management and being well-regarded within the industry for having long tenured employees, transparent communication, and attention to detail is an indication that the CDMO is dedicated to top-tier client management.
Top-Tier CDMOs
The CMOs/CDMOs listed below (in alphabetical order) scored exceptionally high in at least five of the 2020 CMO Leadership awards categories: Capabilities, Compatibility, Expertise, Quality, Reliability, and Service. Explore their websites to determine if they might be a suitable partner for your drug development needs.
3M
3M offers research and development services from pre-clinical through Phase 3 clinical trials and formulated drug production for pharmaceuticals and biopharmaceuticals.
AbbVie
AbbVie offers research and development services from pre-clinical through Phase 3 clinical trials, drug substance production, and formulated drug production for pharmaceuticals and biopharmaceuticals.
Almac
Almac offers research and development services from discovery through Phase 3 clinical trials, drug substance production, and formulated drug production for pharmaceuticals.
Avid Bioservices, Inc.
Avid Bioservices, Inc. offers research and development services from pre-clinical through Phase 3 clinical trials and drug substance production for biopharmaceuticals.
Baxter
Baxter offers research and development services for Phase 2 and Phase 3 clinical trials, drug substance production, and formulated drug production for pharmaceuticals.
Boehringer Ingelheim
Boehringer Ingelheim offers research and development services (preclinical and clinical), drug substance production, and formulated drug production for biopharmaceuticals. It has expertise in Aseptic Fill/Finish, Liquids, Lyophilized Products, Peptides, Proteins, and pre-filled syringes.
Cambrex
Cambrex offers research and development services (discovery through clinical), drug substance production, and formulated drug production for pharmaceuticals.
Dr. Reddy’s
Dr. Reddy’s offers research and development services (discovery through clinical), drug substance production, and formulated drug production for pharmaceuticals.
Evonik Corporation
Evonik Corporation offers research and development services (pre-clinical and clinical), drug substance production, and formulated drug production for pharmaceuticals.
FujiFilm
Fujifilm offers research and development services (pre-clinical and clinical), drug substance production, and formulated drug production for biopharmaceuticals.
Grifols
Grifols offers research and development services (clinical), drug substance production, and formulated drug production for pharmaceuticals and biopharmaceuticals.
Hovione
Hovione offers research and development services (preclinical and clinical), drug substance production, and formulated drug production for pharmaceuticals.
Lonza
Lonza offers research and development services (preclinical and clinical), drug substance production, and formulated drug production for pharmaceuticals and biopharmaceuticals.
Millipore Sigma
Millipore Sigma offers research and development services (discovery through clinical), drug substance production, and formulated drug production for biopharmaceuticals.
PCI Pharma Services
PCI Pharma Services offers formulated drug production for pharmaceuticals.
Samsung Biologics
Samsung Biologics offers manufacturing, development, and analytical testing services as well as drug substance production and formulated drug production for biopharmaceuticals.
Siegfried
Siegfried offers research and development services (clinical), drug substance production, and formulated drug production for pharmaceuticals.
Syngene
Syngene offers research and development services (discovery through clinical), drug substance production, and formulated drug production for pharmaceuticals and biopharmaceuticals.
Thermo Fisher Scientific
Thermo Fisher Scientific offers research and development services (preclinical and clinical), drug substance production, and formulated drug production for pharmaceuticals.
Vetter Pharma International GmbH
Vetter Pharma International GmbH offers research and development services (clinical) and formulated drug production for pharmaceuticals and biopharmaceuticals.
WuXi Biologics, WuXi STA, STA Pharmaceutical, a Wuxi AppTec Company
WuXi Biologics offers research and development services (discovery through clinical), drug substance production, and formulated drug production for biopharmaceuticals. WuXi STA, STA Pharmaceutical,a Wuxi AppTec Company offers research and development services (preclinical through clinical), drug substance production, and formulated drug production for pharmaceuticals.
Topics #CDMO
