JHS has a unique set of capabilities that allows us to complete projects with fill finish and lyophilization from clinical through commercial drug product. These capabilities have aided us in having a strong track record with United States government programs where we are able to manufacture sterile and non-sterile dosage forms. Our team at JHS is also experienced in writing US government program proposals that have a high success rate.

Our facilities across North America provide specialized manufacturing services for the pharmaceutical and biopharmaceutical industries offering a full range of other support, from process qualification through commercial release.

Successful Track Record of Government CMO Projects

JHS has a long history of supporting US responses to public health emergencies (PHEs). These include US efforts to combat COVID, H7N9 Influenza, botulinum toxin, and plague at the requests, respectively, of the Department of Defense (DoD), the Centers for Disease Control and Prevention (CDC), and the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). In addition, JHS has served as a critical supplier to the Strategic National Stockpile (SNS), one of our country’s most critical PHE assets.

As a CMO partner, we are flexible and responsive in providing a high state of compliance and expertise in expediting tech transfer to produce effective products domestically.

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Sterile Injectable

Finding the right contract manufacturing organization partner to help navigate this scale-up can greatly simplify the process, but vetting CMOs for their capacity, expertise, and capabilities can pose its own unique challenge.

Jubilant HollisterStier LLC has entered into a cooperative agreement for $149.6 million (USD) with the Army Contracting Command, in coordination with multiple federal agencies. This agreement will enable the company to double its injectable filling production capacity at a total cost of $193 million, at its Spokane, Washington manufacturing facility by 2025.
Tech Transfer
There are many reasons behind the success, or failure, of a technology transfer. The transferring of knowledge, experience, documents, and processes involved in developing a drug product from the sponsor to the contract manufacturing organization (CMO) is complex. But at the center of this complexity is one critical role: project management in the tech transfer.

Elevating Your Vision with Personalized Support

Contact us today and let’s explore how we can support your next project.