Ensuring Success at Every Stage
We provide custom drug and clinical supplies manufacturing, packaging, and distribution to support clients at every stage of development and commercial supply.
DefenderSD Manufacturing’s capabilities include:
cGMP Manufacturing of Drugs
Aseptic processing of Ophthalmic Drugs
Non-sterile liquids: emulsions, gels and suspensions
Clinical Trial Packaging Materials
Aseptic Fill and Finish
Our aseptic fill and finish facilities are equipped to support our clients at each stage of the development cycle. Our ability to fill small product lots for early development as well as commercial scale batch sizes means that DefenderSD clients can maintain consistent product supply as their volume needs increase through the clinic and to the market. By combining the expertise and experience of a large contract manufacturing organization with the personal attention and flexibility of a smaller manufacturer, we have the capacity to meet client demands while ensuring no detail is overlooked.
Formulation
Before being sent into a cGMP filling suite, DefenderSD formulates and sterile filters (if necessary) our client’s products to ensure a stable and quality final drug product. If you have an existing formulation, we can transfer and adapt your process to our facility. Once your formulated product is ready to be filled, the liquid is transferred directly to the appropriate cGMP fill suite to be aseptically filled to the specified dosage form. Whether you are entering the clinic to achieve proof of concept or gearing up for a new product commercial launch, we have the capability and capacity to support your organization.
Clinical Packaging
At DefenderSD, we understand the flexibility required for clinical studies and can create customized patient kits for all dosage forms, store finished product at a variety of temperatures and ensure that clinical trial materials are reliably delivered to clinical sites worldwide. Our packaging capabilities include cartons, chipboard boxes, laminated corrugated boxes, foam inserts, directional inserts, thermoform trays, insulated shippers and single and multi-panel labels.
Our innovative, cost-effective services adhere to the highest standards in quality, customer service and reliability. We use cGMP compliant systems and facilities to manage the packaging, labeling, cold chain management, and logistics to support the clinical supplies needs of our clients of all sizes. DefenderSD’s cGMP production facility includes controlled access and monitored packaging suites, walk-in 2-8C° and -20C° storage areas and controlled room temperature. Redundant refrigeration systems and alarms reduce potential risks associated with cold storage.
Interested in our services, partnerships, manufacturing practices, careers or other topics? We encourage you to reach out.