Aseptic Fill & Finish
Whether you are looking to move a product candidate into the pre-clinical setting, clinicial setting or into the market, Althea has the experience and capability to get you there. We have filled over 1,500 cGMP finished product lots for our clients, and are able to provide a reliable supply of finished product in vials or prefilled syringes for every stage of development and commercialization. We have a tremendous level of expertise working with complex formulations, including liposomes & nanoparticlees, conjugates, and adjuvants. If a formulation or modification to an existing formulation is needed, our formulation group will tailor the development to the specific needs of your molecule, ensuring delivery of a stable and high quality product to the patient. If your molecule requires the added stability of lyophilization, we can optimize the lyophilization cycles as needed and then lyophilize the product in our cGMP facility.
We understand that each product has its own specific set of manufacturing needs and that supply chains can be delicate juggling act when tying together timelines across multiple service providers in pursuit of accelerating development time through the clinic. As one of the few fully-integrated development and manufacturing service providers in the industry, many of the steps in your supply chain from drug substance to final product can be consolidated when you partner with Althea to reduce the time, cost, risk of moving product across multiple service providers.
PROJECT MANAGEMENT & BUSINESS PROCESS
Working with you from start to finish.
QUALITY & REGULATORY
Taking pride in our history of quality.
Aseptic formulation and fill using static mixers. Plasmid DNA or other API is formulated into non-filterable complex using sterile static mixer. Formulated product is filled and lyophilized.