Bachem (Switzerland)

Feb 14, 2024

Hauptstrasse 144, 4416 Bubendorf, Switzerland

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ABOUT BACHEM

The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe and the US, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.

Bachem. Pioneering Partner for Peptides

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RESEARCH PRODUCTS

As market leader in peptides, we are able to offer you a wide range of biologically active peptides and biochemicals for research purposes.

New Products

Bachem is continuously expanding and updating its extensive range of products for your research purposes. Find all new catalog products listed here.

Catalog Products

Bachem offers more than 6500 different biologically active peptides, amino acid derivatives and biochemicals from stock, ready to deliver. These products can befound in our Online Shop or in our main catalog (peptides, building blocks forpeptide synthesis and non-peptidic biochemicals).

Custom Synthesis

If you need products that are not offered from stock, our custom synthesis team is happy to support you in bringing your project from research scale to bulk cGMP Active Pharmaceutical Ingredient (API) utilizing effective technology transfer between Bachem locations worldwide.

Glycosylated Peptides

The selective chemical glycosylation at large scale has potential to be applied to a variety of peptides, where we can pioneer the concept of improving current and future drugs via chemical glycosylation.

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API PRODUCTS

Bachem is the world´s leading independent manufacturer of peptide active pharmaceutical ingredients (APIs) and a well established manufacturer of small molecules APIs. Each year, Bachem manufactures hundreds of batches of drug substance for projects in clinical trials and for products on the market. Bachem is currently involved in more than 150 cGMP development projects targeting New Chemical Entities (NCEs) and Bachem offers a range of more than 30 generic drug substances. We have the capacity to produce peptide APIs from gram scale up to annual quantities of hundreds of kilograms and small molecules APIs from gram scale up to annual quantities of tens of tons.

Compliance to cGMP regulations and to the corresponding guidelines is key to our success. Bachem has gained the required expertise from a multitude of successful registrations all over the world: Bachem has 65 national EDMF approvals, 35 active US-DMFs, 10 CEPs, and several active DMFs in many other countries. We have submitted many technical packages in support of successful IMPD and IND applications. Our GMP manufacturing facilities are located in Switzerland and the United States and are regularly inspected by the FDA and local authorities. More details on our cGMP production sites in Europe and the USA.

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Generic APIs

Bachem offers a range of more than 30 generic products of which more than 20 are peptides.Our generic APIs are used in the field of cancer, diabetes, obesity, fertility and many more.We have the capacity to produce generic peptide APIs in quantities of hundreds of kilogramsand small molecules in tens of tons per year. For more information please download our Generic APIs Catalog.

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New Chemical Entities (NCEs)

For New Chemical Entities, Bachem forms project teams with a project manager to coordinate and control the project activities and with team members out of research and development, quality control, quality assurance, regulatory affairs and sales to represent their department within the project. A business development manager is part of the team and addresses your special needs and requirements.

Bachem has more than 45 years of experience in the development, production and filing of peptide and small molecule active pharmaceutical ingredients (APIs) as well as in the manufacturing of clinical trial materials from peptides (Clinalfa®). For more information please download our NCE Brochure.

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Clinalfa®

Clinalfa® is Bachem’s brand name for sterile peptides and related services. Clinalfa® products are manufactured and released by Bachem Distribution ServicesGmbH, Weil am Rhein, Germany.

The following Clinalfa® product lines are available from Bachem:

Clinalfa® basic products are sterile freeze-dried peptides readily available from stock. The supply of Clinalfa® basic peptides is accompanied by Bachem’s Certificate of Analysis (CofA) signed by Bachem’s Qualified Person (QP). The manufacturing process and the analytical methods might not be fully validated andonly limited stability data are available.

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Clinalfa® plus products are sterile freeze-dried or ready-to-use liquid formulations made according to customer requirements. In many cases, the active pharmaceutical ingredients (APIs) and the resulting Clinalfa® products are proprietary products of Bachem’s customers. Based on agreements between the customer and Bachem, Bachem’s Qualified Person (QP) may release the products for use in a specific clinical study approved by the competent authority, and also for market approval. Clinalfa plus products are sold exclusively to “Authorized Persons and Companies”. Clinalfa® plus products can be used in pre-clinical or clinical studies (clinical trials) provided that such clinical studies fully comply with the international ethical and scientific standards as stated in the ICH guideline for Good Clinical Practice E6(R1). The level of validation of the manufacturing process and analytical methods,the design and duration of post-release stability studies and the content of CMC documentation is customized based on the developmental stage and intended use of the products.

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Clinalfa® Services

Bachem offers related services to Clinalfa® basic and Clinalfa® plus products, i.e. formulation development, compatibility studies, stress test and post-release stability studies, CMC-documentation for IMPD and IND, drug master file and other services.

Europe, Africa, Middle East and India

Bachem AG

Hauptstrasse 144, 4416 Bubendorf, Switzerland

Tel +41 58 595 2021

Fax +41 58 595 2040

Email [email protected]

Americas

Bachem Americas, Inc, 3132 Kashiwa Street, Torrance, CA 90505, USA

Tel +1 888 422 2436 or +1 888 4BACHEM or +1 310 539 4171

Fax +1 310 539 9428

Email [email protected]

Asia Pacific

Bachem Japan K.K.,AREA Shinagawa, 13F, 1-9-36 Konan, Minato-ku, Tokyo 108-0075, Japan

Tel +81 70 7460 2583

Email [email protected]