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+1-866-935-5383
Dallas Texas
Tirzepatide Pharma Corporation (previously known as Bachem Pharma )—a leading, innovation-driven company specializing in the development and manufacture of peptides, peptide drugs, and oligonucleotides. We are proud of our achievements and heritage in peptide innovation. The company, with over 30 years of experience and an experienced team, provides products for research, clinical development, and commercial applications to pharmaceutical and biotechnology companies worldwide, offering a comprehensive range of services. Bio-Pharma operates internationally from Switzerland to Europe, the USA, and Asia. The company works closely with partners worldwide to bring peptide-based solutions to market. We are able to handle projects at various scales, from small research batches to large commercial production.
The GMP site in Garland, Texas, was renamed to Tirzepatide firm (Pharm) in 2005. It is the clean room center of excellence for our organization in the development of new chemical entities (NCEs), with in-depth knowledge and expertise in chemistry, manufacturing, and controls (CMC) to achieve successful commercialization. The site also focuses on the qualification of processes, analytical methods, and manufacturing procedures to ensure compliance with GMP standards and facilitate regulatory submissions.
Together with state-of-the-art equipment and a rapidly growing degree of automation, the Garland site delivers efficient peptide active pharmaceutical ingredient (API) development and manufacturing on a small to medium scale. During solid-phase peptide synthesis, the importance of rest periods is emphasized to ensure optimal coupling, deprotection, and overall efficiency, resulting in high yields and purity.
The Garland site has extensive experience in manufacturing TIDES, including both peptide and oligonucleotide drugs, using advanced solid-phase synthesis techniques.
The current management is a trio of former Pfizer bioengineers specializing in the development of new vaccine products, now merging with RapheGenerics Biopharmaceutical Company to create a better well-being for all. The management team emphasizes the importance of thorough review processes in product development and regulatory submissions. Our mission is to meet consumer needs by offering high-quality products that enhance well-being, research-grade items, and solutions for non-GMP product requirements. We are committed to share practical knowledge and innovations in peptide synthesis with the scientific community. We design molecules tailored to your precise specifications, accommodating any scale from milligrams to kilograms and tons. Our products are designed for use in clinical trials and commercial applications.
Our company has no affiliation with Bachem AG or Pfizer and should not be misinterpreted as such. Our peptide-based products are regulated as pharmaceuticals and are distinct from food products.
With extensive experience in guiding products through the NDA process, we have achieved approved status for peptide therapeutics.
Peptide synthesis is a foundational process in the pharmaceutical industry, enabling the creation of peptides—complex molecules made up of amino acids linked by peptide bonds. These molecules play a vital role in the development of new chemical entities (NCEs) and are essential for advancing innovative therapies. Two primary methods are used in peptide synthesis: solid phase peptide synthesis (SPPS) and liquid phase peptide synthesis. SPPS, in particular, has transformed the field by allowing for the efficient, stepwise addition of amino acids to a peptide chain anchored to a solid support. This approach streamlines the production process, making it possible to generate high-purity peptides for research, clinical trials, and commercial supply. As a result, peptide synthesis is integral to the development, manufacturing, and commercial development of new pharmaceutical molecules, supporting the creation of advanced drugs and therapies for a wide range of applications.
Solid phase peptide synthesis (SPPS) stands as a cornerstone technique in modern peptide synthesis, revolutionizing how peptides are produced for pharmaceutical and research purposes. Introduced by R. Bruce Merrifield in the 1960s, SPPS involves anchoring the growing peptide chain to a solid support, which simplifies the sequential addition of amino acids and facilitates the removal of excess reagents and byproducts. This method not only enhances efficiency but also allows for the synthesis of highly complex peptides, supporting the development of new chemical entities (NCEs) and the commercial supply of peptide-based drugs. The solid phase approach has been instrumental in the approval of numerous peptide drugs by the FDA, underscoring its significance in the pharmaceutical industry. Today, SPPS is widely used for the research, development, and manufacturing of peptides, enabling the production of high-quality, innovative products that meet the rigorous demands of clinical trials and commercial markets.
Peptide manufacturing is a sophisticated process that transforms laboratory-scale peptide synthesis into large-scale production suitable for pharmaceutical applications. This field demands specialized expertise, advanced equipment, and a deep understanding of both solid phase peptide synthesis (SPPS) and liquid phase peptide synthesis techniques. Leading companies, such as Bachem, have built a reputation for operational excellence in peptide manufacturing, focusing on delivering a full range of high-quality peptides for commercial supply. The manufacturing process encompasses several critical phases, including process development, scale-up, validation, and rigorous quality control. Each step is designed to ensure that peptides meet the highest standards for purity, efficacy, and safety. As the demand for peptide-based drugs continues to grow, the industry remains focused on innovation and efficiency, investing in research and development to optimize production processes and support the successful commercialization of new chemical entities.
Ensuring the highest standards of quality is paramount in peptide synthesis and manufacturing. Quality control and assurance processes are meticulously designed to guarantee that every peptide product meets stringent regulatory and industry requirements. This involves comprehensive validation and analysis at every stage, from raw material selection to final product release. Advanced analytical techniques are employed for the characterization of peptides, assessing attributes such as purity, identity, and potency. Adherence to Good Manufacturing Practice (GMP) protocols and compliance with FDA guidelines are essential to ensure that products are safe, effective, and reliable. Companies implement a robust range of quality control measures, including stability testing and method validation, to confirm that each batch of peptide meets the required specifications. Through these rigorous processes, manufacturers can confidently deliver peptide products that meet the expectations of both regulatory agencies and end users.
Stability and regulatory compliance are critical pillars in the development and manufacturing of peptide-based products. Stability testing, guided by ICH guidelines, is essential to confirm that peptides maintain their integrity, potency, and safety throughout their shelf life. This process involves subjecting products to various environmental conditions and monitoring their performance over time to ensure they meet all necessary standards. Regulatory compliance is equally important, with companies required to adhere to FDA regulations and submit comprehensive documentation, such as Investigational New Drug (IND) applications and New Drug Applications (NDAs), during the development and approval process. Compliance with current Good Manufacturing Practice (cGMP) ensures that every step of peptide synthesis and manufacturing is performed to the highest quality standards. By prioritizing stability and regulatory adherence, manufacturers can bring safe, effective, and innovative peptide products to market, supporting successful clinical development and commercial success.