Althea Tech

Website Links

Description

As your drug product progresses through the clinic, Althea will work on creating phase appropriate reference standards that set specifications and controls for assays used during the development of your product. Our team is able to bridge new lots of reference standards to demonstrate equivalence. Every time your drug product is manufactured, we will compare your drug product against the developed reference standards to determine that the product encompasses the same quality, purity, strength, and consistency.

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.

As part of the life cycle development and speed into the clinical setting for your product, Althea can lyophilize your product. We currently have the capacity to lyophilize your early stage clinical product through proof-of-concept. As your product advances toward commercialization and product volume demand increases, Althea can develop the formulation and lyophilize your liquid product as needed to maintain stability and speed into the clinical setting. If you have an existing lyophilization process, we will work with you to transfer and adapt your lyophilization cycles to our equipment.

Althea has the experience and capabilities to provide a thorough understanding of how your molecule behaves over time. We know how critical it is to understand your product at an earlier stage during development so that necessary changes can be made in areas such as formulation, drug delivery, and vial to syringe changes. We will work with you to design a product characterization program, and provide guidance on methods and assays to ensure your product's consistency and quality.

Our biologics Process Development group can develop an entire process or optimize individual steps in an existing process to ensure the process is suitable for manufacturing in a cGMP environment. Up front, our Process Development group can screen production strains to select a cell line that will efficiently provide the best possible expression of your drug substance. We develop processes to take advantage of methods, such as high cell density fermentation, to increase product yield and manufacture the best quality product in the most efficient way possible.

Fact sheet

Company contacts

Products & services

Similar companies nearby