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

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.

Company name: Evonik Industries AG
Year of foundation: 2007
Number of employees: 33,000 employees worldwide
Headquarter Country: Germany
Website: www.evonik.com/exclusive-synthesis

Offered Services

• APIs for clinical & commercial supply
• HP API production
• Continuous Processes
• Homogeneous and heterogeneous catalysis
• API conjugation (PEGs and PEGylation)
• Particle design
• Organometallic and cryogenic chemistry
• Fermentation and Enzymatic Chemistry
• Separation technologies
• Process Engineering
• Chiral Chemistry, Carbohydrates, Nucleoside Chemistry

Evonik is a global specialty chemicals company with a unique portfolio of products and services for the pharmaceutical industry.
It is one of the top three global players in the pharmaceutical custom manufacturing arena and has the world’s largest highly potent active pharmaceutical ingredient (HP API) capacity.
Besides offering process development and production of APIs and HP APIs Evonik is active in the development and production of market-leading excipients as well as oral and parenteral formulations. In the field of custom manufacturing Evonik offers a wide range of solutions from biotechnology-based products and intermediates, to APIs and HP APIs.
Furthermore, Evonik has an experienced R&D team for process development and optimization at each of its sites and plays a leading role in introducing new technologies into the industry. The company’s long-term stability and innovative mindset are reasons why customers entrust their game-changing projects to Evonik.

Company name: Olon Spa
Year of foundation: 1907
Number of employees: > 1200
Headquarter Country: Italy
Website: www.olonspa.com

Offered Services

• Custom synthesis
• Product development
• Pilot manufacturing & scale up
• cGMP compliant production
• DoE
• Gene Synthesis
• Protein Expression & Production
• High potency compounds management
• Regulatory support

Olon SpA is one of the largest European developers and manufacturers, supplying APIs to pharmaceutical industries worldwide for both Generic and CDMO.

In May 2016 Olon acquired Infa Group resulting in an increase of the number of plants from 5 to 8 (FDA inspected).
The acquisition has broadened and diversified the portfolio twofold to more than 200 Generic products and strengthened Olon services to CDMO customers from the early clinical phases up to the commercial manufacturing, thanks to an highly qualified R&D and QA team and an experienced Regulatory team supporting the filings globally.

DIFFERENTIATING TECHNOLOGIES:

• Downstream technologies for concentration/purification and finishing (Ultra, Nanofiltration, microfiltration, RO, desalting)
• Cryogenic reactions (down to -80 °C) for the production of Boronic Acid and for reaction with Hydrides such as Lithium Alluminum hydride and Borane complex or using Organometallic reagent such as Lithiu m or Grignard Reagents
• Technologies to handle hazardous chemistry under cGMP such as Cyanation, Bromuration
• Chromatographic purification (several stationary phases and column shape)

Using our unique technologies our product portfolio includes fermented and semi-synthetic API, HPAPIs, cytotoxic compounds, controlled substances, retinoids, antivirals, recombinant peptides.

Company name: PolyPeptide Group
Year of foundation: 1996
Number of employees: 500
Headquarter Country: Sweden
Website: www.polyPeptide.com

Offered Services

• Chemical synthesis / Custom manufacturing: Manufacturing of pre-clinical peptides
• cGMP-compliant production: Manufacturing of clinical grade peptides as applied to Phase I-III clinical trials and commercial application

The PolyPeptide Group is a privately-held group who focuses on manufacturing of proprietary and generic GMP-grade peptides for the pharmaceutical and biotechnological market.

With more than 50 years of experience, the Group is committed to the highest quality of peptide manufacturing, irrespective of whether this is for approved drug substances, GMP peptides in clinical trials, or small-scale non-GMP custom syntheses.

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.