About Our Capabilites
About Our Biotechnology Firm
Innovative Peptide Solutions
As an FDA-approved manufacturer, we specialise in cutting-edge peptides like Tirzepatide, Cgrillintide, Retatrutide, and Semaglutide. Our commitment to innovation ensures that we deliver high-quality API peptides for both research and clinical development – global provider of peptides for research, clinical development, and commercial application.
About Our Team`s Capability
We Offer Service and Technology that Results in Wellness
We are a trio of former Pfizer bioengineers specializing in the development of new vaccine products, now joining USA Bachem Pharma to create a better well-being for all. 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 design molecules tailored to your precise specifications, accommodating any scale from milligrams to kilograms and tons. Rely on our expertise to produce complex peptides with various modifications, utilizing advanced synthesis methods and cutting-edge automated production technology. With 30 years of experience, we are excited to embark on this new journey.
Peptide Scientist
Bioengineer Physicist
New Drug Pharmacologist
Dependable Quality Management for Research-Grade Peptides.
USA Bachem Pharma Corporation is a leading, innovation-driven company specializing in the development and manufacture of peptides, peptide drugs, and oligonucleotides. The company, with over 30 years of experience and expertise, provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide, offering a comprehensive range of services. Bachemistry operates internationally with headquarters in Switzerland and locations in Europe, the US, and Asia.
The GMP site in Garland, Texas, was founded in 2005 and acquired by USA Bachem Pharma in 2025. It is the center of excellence for the Americas 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. 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.
USA-Bachem- Pharma Quality Grade
Our Quality Grade ensures that you adhere to the existing regulatory standards concerning cosmetic ingredients, amino acid derivatives, and building blocks. You can be assured of batch-to-batch consistency, which provides you with the highest level of confidence in the quality and dependability of our products for your formulation.
With our extensive experience as a supplier of peptides to the human pharmaceutical sector, we are well-positioned to be your ideal partner. Rely on us for premium raw materials, coupled with careful management of changes and deviations, ensuring you have peace of mind during the entire process.
Support at every stage
Become our esteemed partner in the field of peptides. Receive comprehensive assistance during the entire product development process, starting from initial R&D and extending to commercialization.
Count on our ISO 13485-certified peptide manufacturing, which serves as a raw material for medical devices. Our Swiss Center of Excellence specializes in the production of Research Chemicals.
Utilizing state-of-the-art equipment and offering a variety of essential services, such as: Medical Device File, Critical change control, Dedicated equipment, Tailored vialing and formulation of peptide mixtures
GMP-Grade Peptide NCEs and Oligopeptide
Peptide Drugs and Oligopeptide
Our team of genetic engineers is developing gene therapies for a range of genetic diseases. We utilize CRISPR/Cas9 technology and other cutting-edge techniques to develop therapies that have the potential to treat and cure genetic diseases.
Combining innovative peptide science and flexible GMP manufacturing capabilities. AmWiner offers GMP-compliant synthesis services for peptide NCEs and commercial peptides. We offer GMP-compliant synthesis services for peptide NCEs and commercial peptides. We provide optimized and scaled-up drug substance. Our peptide development and manufacturing platform provides comprehensive CRDMO/CMO services, capable of handling a diverse range of peptide projects.
Services
Peptides are one of the fastest-growing therapeutic modalities. We have extensive experience in peptide development and manufacturing of linear and branched-chain amino acid peptides. We can help develop various classes of NCEs and generic peptides, such as:
- Linear and branched chain peptides up to 43 AA
- Small scale size from 1g to 5kg to support ANDA product registration.
- Our generic peptide specialty is Generic Peptides, Peptide NCEs, and Custom Peptides.
Our advanced technology, combined with modern infrastructure, enables us to produce up to 5 kg of linear and branched-chain peptides using solid-phase and hybrid-phase techniques. We offer Peptide manufacturing services from our state-of-the-art facility in Garland, Texas. Major regulatory bodies, including the US FDA, MHRA, and PMDA, regularly inspect this site. We possess extensive expertise and infrastructure for the downstream purification of peptides using RPHPLCs, along with mass spectrometer tools and fully automated ion chromatography.
Why work with us?- We have the knowledge and 30yrs Experience
- Guaranteed raw materials: Rely on a competent supply of raw and starting materials, assuring the utmost quality for your formulations.
- Committed compliance: Experience tranquility with our compliance team supervising quality management and release procedures.
- Specifications customized to your requirements: Offering transparency and consistency throughout the specified product life cycle.
- Validated analytical techniques: Guaranteeing accuracy and dependability in every analysis. Managed change control: Enjoy smooth operations with change management applied to manufacturing processes, analytical techniques, and specifications.
- Effective deviation management: Prompt resolution of any deviations through a proactive approach. Accuracy in manufacturing: Complying with established standards, utilizing qualified analytical instruments for optimal outcomes.
- Certified safety protocols: Maintain confidence in our TSE/BSE certification, safeguarding the integrity of our products. Unyielding purity: Outstanding purity standards, surpassing your expectations for product quality.
CMO-Contract Manufacturing Organization
As a trusted contract development and manufacturing organization (CDMO) partner, we combine research and development (R&D), formulation, and scalable manufacturing to meet your unique needs. With a focus on quality and speed, we provide seamless support throughout the lifecycle of your product.
PeptideNCEs offer comprehensive process development services to identify and optimize the most efficient and scalable processes for New Chemical Entities (NCEs), Advanced Intermediates, and Key Starting Materials (KSMs). Our approach is centered around customer requirements, ensuring that every stage of development aligns with their goals for reproducibility, consistent quality, robustness, production-friendly cost-effectiveness, and regulatory compliance.
Drug product development services provide unparalleled expertise and cutting-edge facilities, designed to meet the most stringent industry standards. Our advanced development center is equipped with specialized analytical and formulation laboratories, enabling precise and efficient drug formulation. Complemented by GMP-accredited manufacturing suites, we ensure that every product adheres to the highest quality and regulatory standards. We are committed to providing end-to-end solutions that accelerate the success of your drug products, with a focus on quality, innovation, and efficiency at every stage.
