Delivering sterile products from benchtop to patient.
Woodstock Sterile Solutions is a leading global provider of best-in-class sterile development and manufacturing solutions – with a decades-long track record of helping the healthcare companies advance molecules through clinical development into full-scale commercial production.
In addition, Woodstock Sterile Solutions is one of the leading contract development and manufacturing (CDMO) providers for sterile liquid formulations. This strong manufacturing orientation ensures your products will be on target and on time.
Advanced aseptic blow-fill-seal technology is used extensively for liquid filling of primary containers for solutions, suspensions and emulsions, but organizations are hesitant to use BFS for biologics and large molecule formulations due to the products’ thermal sensitivity and the heat generated during the BFS process.
Woodstock Sterile Solutions has extensive experience and proven history of manufacturing biologics in BFS with our patented processing to minimize and control the potential heat impact on the product. Dr. Waiken Wong, our Manager of Development Engineering, explains the technology and discusses the other advantages of using BFS technology in his webinar, Blow-Fill-Seal: Advanced Aseptic Manufacturing for Temperature-Sensitive Drug Products. To view the webinar, contact us.
Woodstock Sterile Solutions’ Blow-Fill-Seal (BFS) is an advanced, aseptic liquid filling technology, where the product containers are formed, filled and sealed in a matter of seconds through a continuous and automated process. BFS technology reduces human intervention compared with traditional sterile filling. It is commonly used and is the standard of care in the ophthalmic and respiratory areas but can be utilized for a wide variety of applications.
Expertise in Complex
Specialized in handling complex solutions, suspensions and emulsions.
Flexible BFS Options
Cost-efficient, standard bottle sizes or custom-designed containers.
Capacity & Scale
From clinical development to large-scale commercial projects.
Decades of experience, industry-recognized experts and leading CDMO capabilities.
Unique capability for aseptic insertion of components such as tip/cap assemblies.
Our commitment to innovation reduces development time for our customers.
Faster to Market
As a highly focused organization, our expertise and commitment to innovation allow us to reduce development times and efficiently bring products to market – delivering them globally and diverse regulatory environments.
At Woodstock Sterile Solutions, your first delivery system can be your final delivery system – increasing speed to market and enhancing scalability.
Trusted, Efficient Development Capabilities
Early-stage APIs are some of the most valuable materials in the world. Woodstock Sterile Solutions has a track record of careful stewardship with clinical scale APIs throughout the entire drug development process. We have specialized handling equipment for a wide range of materials and offer small-scale finish-fill manufacturing equipment that can handle smaller batches at the start – but that allows seamless scale-up to commercial production. At Woodstock Sterile Solutions, your first delivery system can be your final delivery system – increasing speed to market and enhancing scalability.
Broad Registration, Accreditations and Certifications
- Registered for drug, device and food manufacturing with the U.S. Food and Drug Administration (FDA)
- State license for wholesale drug manufacturing and distribution licenses
- Certifications through EU-competent authorities
- Manufacturing accreditations for Japan, Australia, Canada and Brazil
- Potent material handling Safebridge 1-4
- ISO 13485:2016 Certification
Quality and Reliability Driven by Healthcare Outcomes
At Woodstock Sterile Solutions, we see a patient, family member or friend in every product we make. Our quality systems feature best practices driven by the regulatory requirements of multiple regions around the world. At Woodstock Sterile Solutions, we are committed to long-term sustainable partnerships. With every project, we recognize the trust that our customers are placing with us, and we are determined never to let them down.