• 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.

Modular Manufacturing

• Other than doing in-house production, one alternative to CDMO is modular manufacturing.
• Using modular facilities can help "accelerate commercial production while spreading out capital expenditures" across several years. This approach also offers opportunities to scale more easily over time.

BioPharm

• 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."

Biogen

• 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."