Peptide Services
AmWiner manufactures the highest quality peptide products with some of the lowest costs in the industry. We have established relationships with the major raw material manufacturing companies for amino acid derivatives and solvents. Due to the large quantities of raw materials we purchase and our proximity to the source, we can keep costs low. Additionally, we have implemented solvent recovery systems to further reduce manufacturing costs by up to 50% on our large-scale commercial operations, while also minimizing solvent waste and applying sustainable or green chemistry principles. Whether you need a peptide for early research, a new chemical entity (NCE) in clinical trials, a peptide API for commercial production, or analytical development and validation services, we would be happy to be your lifelong partner..
HPLC Analytical Chemistry Services
In analytical chemistry, the HPLC process plays a pivotal role due to its precision and versatility. It provides a reliable means of analyzing complex mixtures, making it indispensable in various fields, including pharmaceuticals, environmental science, and food safety. The ability to detect and quantify trace amounts of substances is particularly beneficial in pharmaceutical research, where the purity and concentration of compounds are critical.
The importance of the HPLC process extends to quality control in manufacturing, where the consistency and safety of products are paramount. By ensuring that each batch meets stringent specifications, HPLC helps maintain product integrity and regulatory compliance. In environmental monitoring, the technique is used to detect pollutants and contaminants, contributing to efforts in safeguarding public health and the environment.
Furthermore, HPLC is integral to research and development efforts across multiple disciplines. From identifying novel compounds to studying complex biochemical interactions, the process provides a window into the molecular world. As researchers, we rely on the HPLC process to deliver accurate and reproducible results, which form the foundation of scientific discovery and innovation.
GMP Services
AmWiner has multiple manufacturing suites capable of producing peptide APIs (Active Pharmaceutical Ingredients) at varying scales, ranging from grams to multi-kilogram scales (>100 kg). Depending on the peptide, we may use solid-phase synthesis, solution-phase synthesis, hybrid solid/solution-phase synthesis, and convergent synthesis to produce new chemical entity (NCE) peptide APIs.
Analytical Development & Validation Services
Concurrently with the development process, Raphegenerics will develop analytical HPLC (High-Performance Liquid Chromatography) or UPLC (Ultra-Performance Liquid Chromatography) methods and validation tools. These tools will monitor the process for side reactions, ensure the required purity standards are met, and limit any residual impurities in the product.
NCE Services
Raphegenerics has years of experience manufacturing Active Peptide Ingredients (APIs) for peptide vaccines in varying configurations. Our expertise in high-quality manufacturing enables us to produce the peptide construct to cGMP standards, providing both quality and value. We also provide guidance on knowledge in three key areas that are critical to successful implementation: analytical, formulation, and regulatory.