Alternative to CDMO
To determine the alternatives to using a CDMO and how the alternatives compare in terms of services offered and value to pharmaceutical companies.
In addition, to find out whether the alternative to CDMO is in-house manufacturing and how companies decide whether to use a CDMO, handle production themselves, or use a third alternative.
- While there is a lot of information available regarding alternative approaches used by CDMOs such as Continous Manufacturing (CM) and batch processing, how companies make the "buy/outsource" vs "make" decision, how small vs large companies select a CDMO, the pros, cons, and challenges of outsourcing to CDMOs, and solutions to overcome the challenges of outsourcing to CDMOs, not much information exists about alternatives to the CDMO approach itself.
- In 2011, the US-based Biologics Modular started leasing its mobile production facilities to help pharmaceutical companies in manufacturing drugs without using fixed plants or outsourcing to CDMOs.
- The company leased its modular plants to BioPharm, a research park innovator that needed access to an affordable and flexible GMP production capacity.
- Biologics Modular pitched their modular plants as an alternative to using CDMOs that can help companies temporarily install manufacturing plants on-site instead of outsourcing production.
- Once constructed, these modular plants can be assembled and relocated anywhere, including a leased industrial warehouse.
- "When the plant is no longer needed, it can be decommissioned. In most cases, Biologics Modular handles its removal."
- Another biotechnology company, Biogen, adopted the modular plant approach in developing an Alzheimer’s drug.
- Instead of building a large, combined manufacturing facility, Biogen decided to "ferment materials in seven smaller, identical and modular facilities that could function independently of one another without disrupting quality or consistency."
- Biogen uses real-time data to perfect the fermentation process.
- The company created a BES Integrated Solution and uses predictive models that continuously evolve and help predict batch quality during the production process.
- This helps Biogen to have real-time access to reports and notifications highlighting any process or quality issues instead of waiting for several days for a lab result. Any issues identified during the production process can be rectified early before moving the entire batch which further saves time and money.
- With the help of its BES Integrated Solution, the company expects to "decrease the testing time by 50%, batch exceptions by 70%, and batch review time by 70% while reducing costs, increasing yield, and expanding production."
- "Using plastic 'single-use' equipment and the 'container approach', where manufacturers are producing materials in modular, 40-foot containers, can further reduce the capital cost of production, minimize supply chain challenges, and reduce energy and water consumption."
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