With over 300 recombinant proteins and antibodies currently approved in the US and Europe, in a biopharmaceutical market that can only be expected to grow, the need for drug developers to consider protein formulation and delivery technologies is more important than ever . Althea's Tod Lauerman recently addressed this topic at the 2012 BIO Convention, speaking about Crystalomics® protein crystallization technology and the advantages it has to offer. Some of the major challenges of therapeutic proteins include their tendency to degrade quickly in the patient's body, and their associated need to be delivered at very high concentrations, often intravenously. Crystalomics® solves some of these stability and delivery challenges, making for an overall safer and more patient-friendly product.
Crystalomics® Key Features Include:
- High Concentration
- Transformation of Delivery Route from Intravenous to Subcutaneous
- Transformation from Daily to Weekly Injections
- Low-ViscosityThe process of crystallizing proteins has been extensively developed and tested as well, showing that the technology is applicable to most, if not all, therapeutic proteins. Over 100 proteins have been crystallized, including antibodies, hormones, enzymes, and peptides. Crystallized products have been shown to retain their molecular integrity and secondary structure, meaning that crystallization does not change the activity of the molecule.
- Full Retention of Molecule Integrity, Structure and Activity
- Addition of Unique Intellectual Property
- Established GMP Manufacturing Process with High Yield and Good Scalability
- Use of Pharmaceutically Acceptable Ingredients
One of Crystalomics® greatest strengths lies in the benefits it has to offer for drug delivery. By formulating proteins as crystalline suspensions, rather than as soluble formulations, Crystalomics® yields significantly higher concentrations and smaller injection volumes. Additionally, crystallized formulations can be delivered through a fine gauge needle due to the crystals' small diameters and the relatively low viscosity of the suspensions. Compared to soluble formulations, crystallized products also remain in the bloodstream for much longer, meaning that Crystalomics® enables protein therapies to be developed as long-acting formulations. Taken all together, this means fewer, simpler, and less painful injections for the patient.
The process of crystallizing proteins has been extensively developed and tested as well, showing that the technology is applicable to most, if not all, therapeutic proteins. Over 100 proteins have been crystallized, including antibodies, hormones, enzymes, and peptides. Crystallized products have been shown to retain their molecular integrity and secondary structure, meaning that crystallization does not change the activity of the molecule.
Not only does Crystalomics® theoretically offer a good solution to protein stability and delivery issues, but with the manufacturing process capable of producing up to 1,800 grams of monoclonal antibodies, and with overall process yields up to 74% for 1L and 65% for 15L, this technology is ready for action.
Click here to learn more about how Althea's Crystalomics® can benefit your product!
Learn more about Althea here.
Source: "Biomanufacturing Outlook 2012" – Eric Langer