Crystalomics® Formulation Technology
Althea’s Crystalomics® Formulation Technology utilizes protein crystallization and complexation for the development of sustained release and high concentration formulations. The Crystalomics® technology allows proteins and other large molecule products to be formulated as crystals in suspension for subcutaneous delivery.
This protein formulation technology enables manufacturers to overcome stability and delivery challenges with drug products that need to be delivered at high concentrations or must be administered frequently. Using the Crystalomics® Formulation Technology, challenging drug deliveries may be transformed into more amenable drug treatment regimens for patients.
Our team has the on-site expertise and capabilities to develop alternative drug delivery formulations with drug substances that are moving into clinical trials. Since technology transfer and scale-up manufacturing work can be performed at the same site, Althea provides a timely and cost-effective solution for your clinical drug development needs.
An article from BioProcess International – Biological Characterization Using Protein Crystal Measurements
Benefits of Crystalomics® Formulation Technology
Our Crystalomics® Formulation Technology benefits both pharmaceutical developers and, more importantly, patients.
|Ability to formulate highly concentrated proteins in small injection volumes with low viscosity||Better compliance without time-consuming IV infusions|
|Scalable to support both clinical stage and commercial manufacturing||Self-injection that doesn’t require trained medical personnel|
|Maintains biochemical characteristics and bioactivity of the soluble protein||Improved patient comfort via use of finer gauge needles|
|Improvement in syringeability and injectability||Non-injection routes of administration possible|
|Flexibility in dosage form–oral, pulmonary, topical and subcutaneous injection possible||Fewer treatments via controlled and extended release formulations|
|Opportunity to extend patent life of branded protein-based therapeutics||Same therapeutic benefits as low concentration formulations|
Althea usually screens over a thousand crystallization conditions. Variables include the types and concentrations of salts, precipitants and buffers as well as combinations of pH and temperature. The best crystallization conditions use pharmaceutically acceptable ingredients and are selected to give the highest yield of uniform crystals of a narrow size range in a relatively short amount of time (usually less than 24 hours).
Automated liquid handling systems facilitate this work, and allow us to quickly and efficiently move forward with scale-up processes. A typical workflow at Althea is shown below.
For more information about Althea’s Crystalomics® technology