The fill and finish step is the final step in the preparation of pharmaceuticals, and it refers to filling the vials with drugs and proper packaging for distribution. It requires rigorous attention to detail and prevention of contamination. Stability and caution are the prerequisites for these operations and they’re the most commonly outsourced sterile pharmaceutical manufacturing service in biomanufacturing.
The traditional filling requires stainless steel equipment connected through valves and pipes. Due to the need for specialized expertise, expensive equipment, and proper care, much of the filling and finishing gets outsourced.
Fill and Finish Outsourcing — A Key Trend
Generally, companies outsource their pharmaceutical fill and finish to Contract Manufacturing Organizations (CMOs) that have access to large-scale production and fill and finish capacity.
Smaller companies with no fill and finish equipment outsource nearly 100% of their needs.
Some big pharmaceutical companies also have some level of filling and finish capabilities, but still, outsource about 40% of their requirements for the following reasons:
- Requirement of temporary capacity during startup
- Balancing volumes of production with line capacities
- Validated manufacturing for commercial products and services
- To gain access to CMOs’ specialized technologies and methodology
- When there is a need to add production and reduce spending
- When special services like handling cytotoxics are needed
Services Outsourced to CMOs
The companies with no built-in filling and finishing systems outsource more analytical testing and assays. Meanwhile, companies with those capabilities tend to outsource lyophilization services, which is a highly challenging stabilization process. Here is a list of services that generally get outsourced to CMOs by various pharma companies:
- Packaging and labeling
- Stability testing
- Regulatory assistance
- Formulation development
- Analytical testing
- Analytical assay development
- Other special services
Changes In Outsourcing Strategies
Due to the recent economic and industry trends, manufacturing companies expect their fill and finish outsourcing strategies to change. 43% of pharmaceutical companies that are keen on changing their strategy intend to increase outsourcing to minimize cost expenditure. On the other hand, 28% of companies plan on decreasing outsourcing by building in and maximizing fill and finish units in their company. The speculated reasons for changes in strategies are:
- Changes in the life cycle
- Changes in the mix of the product
- An attempt to reduce cost
- Risk mitigation
- Reasons specific to individual companies like a change in the company’s business strategy
On the other hand, slightly more than half of the pharmaceutical companies do not plan on changing their outsourcing strategies. This is because 80 percent of these companies have no in-built capabilities of filling and finishing and rely completely on CMOs for sterile packaging needs.
They believe that CMOs have the scale and experience that pharmaceutical companies can not achieve independently. The companies that have their products in clinical trials will decide on filling and finishing outsourcing once the results of these trials surface. The companies intent on outsourcing have shifted the focus towards tapping out better CMOs to meet their demands efficiently.
CMOs provide an essential service to pharmaceutical companies and help save time, effort, and costs. The growth in pharmaceutical companies fuels the demand for better contracts with CMOs. So, along with their growth, companies evaluate their outsourcing strategies and make adjustments depending on technical and economic trends.