How can Working with an Embedded CMO Benefit Your Drug Product?
Pharmaceutical companies regularly turn to contract manufacturing organizations (CMOs) to help progress drugs from development through to commercialization. With specialized resources and facilities, backed by a wealth of expertise, the right CMO can expedite market launch for timely delivery of essential drugs to the patients who need them most. An embedded CMO offers many advantages over other CMO models, not least its access to the extensive capabilities and knowhow of the parent organization. By fully leveraging the experience and assets of AbbVie Inc, AbbVie CMO provides our partners with unparalleled support throughout clinical development, technology transfer, scale-up, manufacturing, packaging, supply chain integrity, and more, backing this with robust quality processes to ensure compliance with global regulatory requirements.
The embedded CMO approach
The pharmaceutical outsourcing environment includes a multitude of stand-alone CMOs, all of which vary considerably in the type and breadth of services they offer. These are complemented by a handful of embedded CMOs that function as part of a larger parent company and report up through the commercial organization. The value of embedded CMOs to the pharmaceutical industry is highlighted by a growing trend for drug development companies to partner with them for the numerous activities essential to support a drug toward commercial launch and beyond.
A business model designed to support strategic growth
A primary advantage of an embedded CMO is that it operates to a business model built to support strategic growth. Unlike stand-alone CMOS, where a capacity-filling approach means they are fully reliant on incoming business and consequently have the potential to over-commit and under-deliver, an embedded CMO does not have to fill capacity in order to continue operating. Instead, it shares in the success of the parent organization – a company that is financially supported by its own drug products – and can leverage the investment made by that company to maintain its position as a global pharmaceutical leader.
The embedded CMO approach promotes a different mentality to that of a stand-alone service provider, not only allowing for selection of partners that best fit the embedded CMO’s technologies and expertise, but also enabling the embedded CMO to support those projects viewed as most valuable to the market. Moreover, since an embedded CMO is driven to deliver on both new and existing projects using the resources it has put in place, it is motivated to treat every drug product as if it were its own, while working to build a long-term relationship that supports the future growth of both parties within a highly competitive marketplace.
Access to a global network
Another benefit of working with an embedded CMO is that it provides partners with access to a global network of resources - including many in-demand technologies - backed by unrivaled expertise. Where other CMOs may have invested in novel technologies based on market trends, an embedded CMO will be using technologies and processes it has applied successfully to develop its own drugs, increasing the capacity of the various platforms as it sees fit. Additionally, by drawing on its own considerable experience, an embedded CMO is ideally placed to engineer solutions to challenging products or processes without incurring unnecessary delays.
A further advantage of working with an embedded CMO is that it will have an up-to-date working knowledge of global regulatory requirements as a result of the parent company having marketed many of its own products worldwide. This translates to superior adaptability to change within a rapidly evolving marketplace, ensuring that drug products maintain regulatory compliance whatever geographical location they are marketed to.
Direct engagement for long-term planning
AbbVie CMO is an integral part of AbbVie’s operations team, giving it a direct line to key decision-makers within the wider organization. As a result, any issues are raised and dealt with readily - at a company-wide level where necessary - while integration of governance teams with senior leadership supports adherence to timelines and promotes forecast discussions around the long-term market of partner projects to drive decisions on capacity and resource.
Every AbbVie CMO project is managed by a dedicated, cross-functional project team, many of whom have worked on developing and manufacturing the company’s own drug products. By applying our technical expertise to our partners’ programs, within the very same facilities we use for own drug products, we ensure delivery on the end goal: bringing essential drugs to the patients who need them most. The value of our embedded approach is widely recognized within the pharmaceutical industry; for example, Life Science Leader magazine has awarded AbbVie CMO the Top CMO award every year since the inception of this award category in 2013.
A one-stop shop for drug development and manufacturing
While stand-alone CMOs frequently deliver only on niche requirements, an embedded CMO supports the entire drug development and manufacturing pipeline. With specialized resources and facilities in place to provide customers with everything they need – from early clinical development through scale-up, packaging, and beyond – all while protecting the confidential information and intellectual property of both parties, an embedded CMO is fast becoming the preferred choice for complete peace of mind throughout the drug development and manufacturing life cycle.
By: Ania VanDyke, Associate Director Business Development, Contract Manufacturing
To discuss how AbbVie CMO can support the development and commercialization of your drug, contact us at 1-847-938-8524 or visit www.abbviecontractmfg.com