Alera Labs offers complete services for drug development. We help our clients turn their innovative ideas into a finished product. A dedicated team of skilled formulation chemists will go to work developing multiple prototypes to identify a winning formulation. Our formulation experts take clients from proof of concept to characterization. The formulation team’s in-depth knowledge covers a diverse range of products, as well as a wide variety of dosage forms and routes of delivery. In addition to our formulation capabilities, Alera Labs also conducts the necessary analyses and container/closure compatibility studies required to move your product through the regulatory process.
- Solution stability studies (define sensitivities to pH, heat, oxidation, buffer, buffer strength, and salt concentration)
- Solubility curves (determine ionization constant (pKa), define solvent and complexing solubility)
- Drug-drug compatibility
- Excipient-drug compatibility
- Agglomeration or micelle determination and size
- Forced degradation and compound/protein stabilization
- Identification and quantification of impurities and degradation
- Stabilizer screening (using pharmaceutical, veterinary oragricultural approved additives)
- Admixture and container/closure compatibility studies
- Photo-stability studies
- Water content determination
Pharmaceutical, Biotechnology, Medical Devices Industry, Cosmetics, Health, and Beauty Industries, Personal Care products Industry (HPLC, GC-MS, LC-MS, LC-MS/MS, Karl Fischer method)
Alera Labs is an accomplished provider of preformulation development services, catering to diverse sectors such as the pharmaceutical, biotechnology, and medical devices industries, as well as cosmetics, health and beauty, and personal care products industries. The company utilizes a host of state-of-the-art techniques in their services, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), and the Karl Fischer.
Alera Labs’ proficiency in HPLC and GC-MS allows for comprehensive analysis of raw materials and compounds during the early stages of product development. In the pharmaceutical and biotechnology industries, this can involve assessing the physical and chemical properties of drug candidates, helping to guide formulation strategies and ensure stability, efficacy, and safety of the final product.
Their expertise in LC-MS and LC-MS/MS provides even greater depth in preformulation studies. These techniques can identify and quantify impurities, degradants, and metabolites, thereby informing the design of robust and reliable formulations. In the medical devices industry, such information is crucial for developing devices that are safe, effective, and reliable.
In the cosmetics, health and beauty, and personal care products industries, Alera Labs’ preformulation development services can guide the formulation of products that are both safe and effective. For instance, HPLC and LC-MS can be used to assess the stability of active ingredients and detect potential impurities, ensuring the quality and safety of these products.
The Karl Fischer method, a specialized technique for determining water content, further enhances Alera Labs’ preformulation capabilities. This can be particularly useful in industries where water content can influence product stability, such as in the formulation of cosmetics or pharmaceutical products.
In summary, Alera Labs’ preformulation development services, encompassing HPLC, GC-MS, LC-MS, LC-MS/MS, and the Karl Fischer, provide invaluable support to industries striving for excellence in product development. By ensuring that formulations are robust, stable, and safe from the outset, Alera Labs helps companies across diverse sectors to bring high-quality products to market.