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PRODUCTS & SERVICES

Contact details 

  • Company name: Bachem AG
  • Year of foundation: 1971
  • Number of employees: over 950 employees
  • Headquarter Country: Switzerland
  • Website: www.bachem.com

Offered Services 

  • Research and bulk quantities available from stock (mg to kg)
  • Peptide synthesis from mg/g to kg scale
  • Development of synthetic routes for scale up
  • Cosmetic & diagnostic peptides
  • Process development and validation
  • Development and manufacturing of APIs from early clinical trials to commercialization
  • Sterile fill & finish for clinical trials (Clinalfa®)
  • Development and validation of analytical methods 
  • Stability studies and identification of impurities
  • Compilation of CMC documentation for IMPD/IND and support for regulatory requests
  • Glycosylation of peptide drugs
  • Supply of (multi-) kilograms to tons of cGMP peptide and small molecule generic APIs (launch quantities, manufacturing of API for marketed drugs)

Bachem is a listed technology-based company focused on peptide chemistry.
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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Contact details 

  • Company name: Capua BioServices S.p.A.
  • Year of foundation: 2015 
  • Number of employees: 190
  • Headquarter Country: Italy
  • Website: www.capuabioservices.com

    Offered Services 
  • Microbial fermentation
  • Primary recovery & purification
  • Liquid and solid handling, incl spray-drying
  • Technology transfer expertise
  • Lab & pilot scale development and manufacturing
  • Scale-up expertise
  • cGMP compliant manufacturing
  • Food-grade compliant manufacturing
  • Analytical services
  • Regulatory support

 

Capua BioServices is a global provider of high-quality services in the field of custom microbial process development and manufacturing. We offer dedicated solutions for proteins, (high-value) small molecules and microorganisms for applications in pharma, food, feed and other bio-industrial markets.

We are one of the largest, independent microbial contract manufacturing facility located in Western-Europe, with a total fermentation capacity of about 1400 m3. In terms of recovery and purification capacity, we house several separated plants with a large diversity of unit operations for product separation and extraction. We have recently expanded our spray-drying capabilities.

For more than 50 years, we have built a track record based on our extensive experience in working with a variety of bacterial, yeast and fungal systems; from lab-, to pilot- to industrial scale.

We have dedicated areas for pharmaceutical manufacturing and food-grade manufacturing and comply to cGMP (FDA and EMA approved), Food (FSSC 22000) and ISO standards (14001). Our teams operate on a 24-hour, 7-days/week schedule throughout the year. 

In addition to our regular manufacturing services and drive for continuous improvement, we also offer pilot plant capabilities for customized product and process development, process scale-down/scale-up, trouble shooting and validation.

 

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Contact details 

  • Company name: CordenPharma
  • Year of foundation: 2006 
  • Number of employees: 1600
  • Headquarter Country: Germany
  • Website: www.cordenpharma.com

Offered Services 

  • Analytical services
  • Chemical synthesis / Custom manufacturing
  • cGMP-compliant production
  • Drug development
  • High potency compounds management
  • Logistics and distribution
  • Pharmaceutical formulations
  • Pre-Formulation & Formulation
  • Powder handling
  • Process development
  • Product characterization
  • Regulatory support
  • Safety testing

CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services. Through a network of fully-inspected cGMP facilities across Europe and the US organized under five technology platforms – Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, Antibiotics - CordenPharma experts translate complex ideas at any stage of development into high-value products.  

Peptides, Lipids & Carbohydrates: Peptide API Production (Solid-phase, Liquid-phase, Hybrid Synthesis; cGMP & non-cGMP), Lipids, Carbohydrates.

Sterile Injectables: Sterile Drug Products, Packaging & Labeling, Sterile Emulsion Technology, Parenterals, Large Pre-Filled Syringes, Clinical Trial Services.

Highly Potent & Oncology: API Development & Commercial Manufacturing 

(SafeBridge Category 4, OEL ≤1 ng/m3), Drug Product Development & Manufacturing (Oral Solid Dosage Forms, Sterile Liquid & Lyofilistion, Primary & Secondary Packaging).

Small Molecules: Development & Commercial Manufacturing (Intermediates, APIs & Excipients, Clinical Supply from Phase I – III), Proprietary & Generic Advanced Intermediates & APIs.

Antibiotics: Non-segregated (Oral APIs, Oral & Sterile Drug Products, Primary & Secondary Packaging) Segregated (Cephalosporins & Penicillins, Monobactams, Primary & Secondary Packaging).

 

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Contact details 

  • Company name: Johnson Matthey
  • Year of foundation: 1817
  • Number of employees: 13000
  • Headquarter Country: UK
  • Website: www.jmfinechemicals.com

Offered Services

  • Chemical synthesis / Custom manufacturing
  • cGMP-compliant production
  • Drug development
  • Drug discovery
  • High potency compounds management
  • Pilot manufacturing & scale up
  • Preclinical research
  • Pre-Formulation & Formulation
  • Process development
  • Product characterization
  • Regulatory support
  • Stability Storage

Johnson Matthey Fine Chemicals provides high quality, value-adding products and services through its four core offerings: Custom Pharma Solutions, Controlled Substances, APIs & Life Cycle Management and Catalysts, ensuring your complex chemistry problems are solved. 

The Custom Pharma Solutions offering is tailored to you and provides a full range of dedicated drug development, scale-up and manufacturing services, through pre-clinical and toxicological studies to development and commercial manufacturing. Its services include: API process development and manufacture, high potency API capabilities, drug conjugates and linkers, catalytic process screening, biocatalysis and Pharmorphix® solid form sciences. 

Johnson Matthey Fine Chemicals’ world-leading services enable new possibilities and cutting-edge advances for your pharmaceutical and chemical products. The company’s expertise and experience in developing and optimising synthetic processes, discovering the most efficient and sustainable routes, and scaling up intermediates ensures products get to market faster. As well as this, Johnson Matthey Fine Chemicals has expertise in high potency handling, controlled substance management and separation technologies. Its global facilities include kilo-laboratories, pilot plant and commercial scale assets, allowing Johnson Matthey to handle the most complex chemistries, including speciality chemical development and a wide range of process conditions whilst adhering to environmental and process safety best practices.

 

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Contact details 

  • Company name: PolyPeptide Group
  • Year of foundation: 1996
  • Number of employees: 800
  • Headquarter country: Malmo, Sweden
  • Website: www.polypeptide.com

Offered services:

  • Peptide API Manufacturing (preclinical and clinical)
  • Modified peptide manufacturing (preclinical and clinical)
  • Analytical method development
  • Generation of Reference Standards
  • Regulatory support

The PolyPeptide Group  is a privately-held group of manufacturing sites which focus on proprietary and generic GMP-grade peptides for the pharmaceutical and biotechnological market. With more than 60 years of experience, the Group is committed to the highest quality of peptide manufacturing for commercial peptide drug substances, GMP peptides in clinical trials, or smallscale non-GMP custom syntheses. 

The PolyPeptide Group has grown by selective acquisition of existing expertise, culminating in its position today as a leader in peptide manufacturing. 

The latest acquisition of the peptide manufacturing facility in Braine-l’Alleud, Belgium is yet another declaration of the PolyPeptide Group’s commitment to anticipate our clients’ needs and to ensure the flexibility of additional capacity for existing and future projects.

The Group has manufacturing facilities in Belgium (Braine l’Alleud), Sweden (Malmo), France (Strasbourg), India (Ambernath) and two sites in the USA (San Diego CA & Torrance CA). As a multinational company with about 800 employees worldwide, its diversity brings breadth and depth of knowledge and experience to the Group. 

The Group’s long-established core strength in GMP manufacturing and broad range of services supports peptide & peptide-like projects, including conjugation to non-peptide moieties, from the bench through to commercialization. With continually increasing capacity for GMP manufacturing, the PolyPeptide Group is stronger and better equipped to serve the needs of its customers at all stages of pharmaceutical peptide development. With its multinational organization, strict focus on peptides and solid financial base, the Group offers an almost unique security of supply to its customers.

Whether your need is gram quantities or 100’s of kilograms of peptide or peptide-like API’s, PolyPeptide’s experience, focus  and established regulatory track record offers Global Support for a Quality Solution. 

Please contact us to see how we could help you with your peptide API needs.

 

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Contact details

  • Company name: RTC
  • Year of foundation: 1972 
  • Number of employees: 150
  • Headquarter Country: Italy
  • Website: www.rtc.it

Offered Services 

  • Genetic toxicology
  • In vivo & in vitro toxicology
  • General toxicology on rodents and no rodents, from acute to oncogenicity studies
  • Reproductive toxicology
    & juvenile toxicology
  • Analytical support

RTC is a fully fledged Contract Research Laboratory located in Pomezia near Rome (Italy) with a track record spanning more than four decades. RTC collaborates with a large range of industrial clients including the pharmaceutical, biotech, chemical, agro-chemical and biocide industries. Our research staff is composed of a highly qualified team specialised in different areas of toxicological research. In our international and multilingual environment we work in compliance with all relevant international guidelines. We are proud to say RTC was awarded the full AAALAC accreditation in 2012 and has since worked with the highest standards for animal welfare. Our research centre works according to  the principles of “Good Laboratory Practice” and holds the GLP Certificate achieved from the Italian Health Authorities.  Furthermore, RTC has repeatedly been inspected by FDA and by the Japanese Ministry of Health and Welfare, our GLP compliance  being confirmed on all occasions. RTC can support its clients from a very early stage of the project,  offering a full range of experimental and consultancy services in order to ensure a tailored approach. Scientific and technological expertise, combined with skills in project management and communication, qualify RTC as the partner of choice for any product development. Serving our clients is our utmost priority.
That is why RTC is deeply committed to serving your needs and attending to every detail of your project. We will guide you during the selection of the experimental design and provide tailored solutions. RTC will ensure close monitoring of each study phase to respect quality and timing. Our staff will constantly keep you informed of progress, every step of the way, since communication and collaboration are essential to achieve success.




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