Althea offers cGMP plasmid production, protein production, formulation and filling services. Plasmid DNA and protein production are offered using both Althea’s industry-leading manufacturing process as well as client developed processes. A range of options are available for formulation and filling services ranging from semi- automated to fully- automated processes for vials and syringes. Althea is focused on offering highly responsive customer service, flexible scheduling, and rapid turnaround times to meet the requirements of both early stage clinical programs and commercial programs alike.
Althea Technologies offers the highest quality protein production services. From establishment of a well-characterized and rigorously tested Master Cell Bank to the final fill of your product, Althea applies extensive experience to consistently achieve project success. Althea's state-of-the-art cGMP facilities have been custom designed for optimal personnel flow, product flow, and regulatory compliance. We will develop a customized, fully-scalable process, capable of producing batch sizes from milligram to multi-gram amounts for use in pre-clinical studies through commercialization that meet the most stringent purity and regulatory requirements.Working in close contact with the client, Althea will design a fermentation and purification process using the latest technology to cater to the specific needs of your project. Stringent quality control testing is performed throughout the process to provide you with the highest quality product in accordance with your particular specifications. You can be assured that your protein was produced without the use of any animal derived products (during fermentation or purification), and that only the highest quality, fully characterized raw materials have been used. By choosing Althea Technologies as your protein supplier, you can be confident that your project is in the hands of experts.
Advantages of Contracting with Althea Technologies:
Individual attention to your specific project needs, designing a process that is completely tailored to your protein production requirements
Experienced in taking bench-top, non-cGMP processes and developing fully scalable, compliant production strategies
Custom designed state-of-the-art cGMP facilities designed for maximum regulatory compliance
Technology transfer between your scientists and our project managers to identify and resolve technical issues
Full regulatory support and assistance with IND preparation
In-house analytical development and method qualification capabilities
Filling process development and component selection
Aseptic vial or syringe filling available in batch sizes from 10 to 50,000 vials or syringes
Althea Technologies
A leading provider of contract services to
the pharmaceutical and biotechnology industries
11040 Roselle Street | San Diego, CA 92121-1205
Toll-free 1-888-4ALTHEA
info@altheatech.com