Manufacturing Services

If your need is to setup a facility for regulatory approval, Benchmark has the experience and expertise to do it faster than anybody else. We also save a large part of your capital investment by right sizing the facility and sharing labour expenses.

We work with companies developing assets that need the manufacturing expertise to move forward.

Manufacturing is a technologically complex, highly regulated process that many product-focused biotech companies face as a critical step to commercializing their products. Usually manufacturing requires long and complex planning, large investment, and highly skilled personnel and, therefore, is a risky business operation. Managing this challenge require a focus expertise that could be provided by specialised organisation like Benchmark.

Reduce risk, accelerate time to market and lower your capital investment

The Benchmark manufacturing expertise is particularly attractive to biotech discovery research or business development groups that are capitalised for discovery or new concepts but are not capital focused on the manufacturing investments.

1) We help reduce the overall operational risk and time to market.

The process of setting up and running a plant is complex and specialized. Slight delays can lead to high opportunity costs in the form of lost sales. Common causes for delays include setbacks in a biologic clinical Phase trials, poor capacity planning, or a lack of effective manufacturing experience. Regulatory issues are another common cause of delays.

For biotech companies without effective manufacturing experience, working with us helps to reduce these operational risks and accelerate the time to production. This is accomplished by leveraging Benchmark experience and skills in setting up plants and navigating through the regulatory system. This also can possibly translate into significant revenue enhancement.

2) We provide access to capacity with lower investments.

For small-to-medium-sized biotech companies, or large biologics companies that prefer to focus on product-focused development rather than manufacturing, we provide access to shared capacity without having to invest in a plant. Working with us helps the biotech company to lower the risks of building manufacturing capabilities for an unproven product.

The Benchmark Manufacturing Advantage

We believe that although biopharma companies have led advancements in biologics manufacturing to date, we are well positioned to help solve many of today's difficult production problems.

Benchmark will likely increase the rate of manufacturing innovation. Unlike traditional biotech companies, we have many resources dedicated to analyzing manufacturing issues and identifying improvement opportunities. In traditional R&D focused biotech companies, discovery and development issues typically overshadow manufacturing improvement initiatives.

We provide an attractive alternative solution to the difficult capital investment problem biotech companies typically face when they need to build manufacturing capabilities for products nearing commercialization. We can accommodate the creation of a manufacturing space within our manufacturing suite concept or deliver the technology transfer to your own facility or a third party facility.

Benchmark's Manufacturing Services conducts all client manufacturing according to established Benchmark or client Standard Operating Procedures (SOPs) and Process Work Sheets (PWS), maintained under a document-control environment.

Benchmark's Manufacturing Services department has designed, built, licensed and operates several individual manufacturing facilities for clients at our Lincoln, NE Campus Headquarters and elsewhere in the world. Our Team is staffed with professionals experienced in facility design and construction. Benchmark can assist in designing a pilot or full-production facility that meets the requirements established during the process development and by the appropriate regulatory body. Time-to-license can be shortened due to an aligned co-development of the process and the facility.

"We innovate on every step of the process"