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Pharma Tech Outlook | Wednesday, February 16, 2022
Contract service providers offer critical services to biopharmaceutical and pharmaceutical enterprises of all sizes. Establishing and managing an effective working relationship and operations is crucial to avoiding compliance difficulties.
FREMONT, CA: Bio or pharma companies range from large, established pharmaceutical or biotechnology enterprises with extensive supply chains to virtual companies that focus exclusively on research and development while outsourcing all development, production, and fulfilment operations. Certain bio or pharmaceutical businesses collaborate with many contract manufacturing organizations (CMOs), while others collaborate with a small number.
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When designing a strategy that integrates contract development manufacturing organizations (CDMOs) and CMOs, two distinct areas to examine are acquiring CDMO or CMO services and managing CDMO or CMO services.
Collaboration and communication: Managing an entirely or partially virtual organization with the assistance of CMOs from all over the world requires a high level of communication and coordination. A modern strategic strategy should not consider the supply chain as a unilateral mandate, with the bio or pharmaceutical firm determining the rules and acting exclusively for its profit. This zero-sum approach, which attempts to maximize the benefit for the bio or pharma business alone, frequently comes at the expense of CMOs. A more modern and effective strategy views sourcing and managing CMOs as a win-win situation based on teamwork and taking into account the interests of all stakeholders. This approach results in a strategic partner who shares an organization's values rather than a transactional vendor.
Effective communication also requires that all parties avoid data silos, favoring a positive data flow between CMOs and contracting organizations. Not only will open data facilitate regulatory supervision, but it will also result in increased supply chain efficiency and more informed sourcing decisions. This free flow of information is orchestrated by the bio or pharma company's CMO manager, who will oversee communication between the company and its CMOs, as well as internal peer-to-peer departments.
Multiple bio or pharma firm personnel serve as the CMO manager throughout the drug's development and commercialization lifecycle. Typically, a technical manager from manufacturing or manufacturing science and technology is appointed as CMO manager first, until Phase III clinical materials are produced. When the drug product to be made by the CMO is approved for commercial use, this function is typically transferred to a supply chain planner or manager; the new CMO manager will retain close contact with the technical manager and will collaborate with them to oversee the CMO in the future.
Typically, the communications infrastructure will include an internal manufacturing science and technology specialist who will be knowledgeable about the product and operate as a point of contact during the product's development. After a year of commercial production, that role is often shifted to a supply chain manager; eventually, it may be transferred to a supply chain director responsible for all product planning and coordination.
The CMO manager keeps the CMOs informed of regulatory changes and future inspections and ensures that the CMOs are sufficiently prepared. This communication is critical to ensuring that the CMO sites adhere to all regulatory requirements and agencies.
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