Eurofins CDMO Corporate Profile

Eurofins CDMO
Eurofins CDMO
2395 Speakman Drive
Suite 2001
Mississauga, Ontario L5K 1B3
Canada
Phone: 905-403-0477
Fax: 905-403-8744
Website: alphoraresearch.com
Eurofins CDMO is a leading global Contract Development and Manufacturing Organization (CDMO) that provides clients with Active Pharmaceutical Ingredients (APIs)/Drug Substance and Drug Product development for biologicals and small molecules. We are experts in breakthrough technologies for API development, highly potent compounds, poorly soluble drugs, lyophilisation processes and specific therapeutic areas (immunotherapies, orphan drugs, pediatric dosage forms, etc.) Involved in the earliest steps, our highly-qualified project management team will propose a complete drug development strategy in compliance with regulations. Operating under strict quality procedures, Eurofins CDMO is accredited through the FDA, EMA, ANSM, ANSES, FAMHP, PMDA, and Health Canada.

Eurofins CDMO

Company Description

Eurofins CDMO Alphora Inc., operating as part of Eurofins CDMO, is a leading provider of Active Pharmaceutical Ingredient (API) and Drug Product (DP) development and manufacturing services for complex small molecules, including highly potent compounds. As a campus style facility, Eurofins CDMO Alphora Inc. offers API and Drug Product Development services as a fully integrated solution or as stand-alone services. 

As an FDA & Health Canada approved CDMO, we specialize in process chemistry, analytical method development and non-cGMP & cGMP API scale-up. Through the integration of synthetic Process R&D, Solid State R&D, and Formulation Development, we offer a full suite of drug development services and manufacturing capabilities to support pre-clinical to commercial success. 

Our Drug Product operations can support development and clinical manufacturing of oral solid dosage forms and complements our existing API development & manufacturing services by providing enhanced quick-to-clinic drug product strategy designed to meet clients’ needs for Phase I and II products.

Company Background 

Date Founded: 2003 

Key Personnel: 

  • Geo Evans, President 
  • Cheryl Young, Vice President, Business Development and Project Management 
  • Elena Bejan, Vice President, Research and Development 
  • Kevin Rosenthal, Business Head, Drug Product Operations 

Services & Capabilities 

  1. API Development & Manufacturing: We support our clients from route selection to process and analytical development, to non-cGMP and cGMP scale-up and more.  
  2. Solid State Research & Development: Our SSRD programs apply High-Throughput Screening Technology for expeditious discovery of new polymorphs, pharmaceutical salts, solvates, co-crystals & particle size engineering. 
  3. Analytical Development & Validation: We focus on the development of analytical methods & phase appropriate specifications to ensure control of the synthetic process & quality of API throughout the program. 
  4. Drug Product Development & Manufacturing: Our innovative pre-formulation & formulation development, state-of-the-art technologies and cGMP production facilities are specifically designed for quick-to-clinic small molecule drug development. 
  5. API Development Services for Phytocannabinoids: We apply our rigorous API development expertise to produce well-characterized, pharmaceutical-grade phytocannabinoids of high purity that cannot be readily achieved through traditional extraction. 

Facilities 

Our facilities are located in Canada and centered within the North American Pharmaceutical Industry. Our fully equipped laboratories and manufacturing services include: 

  • Synthetic Organic Laboratories 
  • Non-cGMP & cGMP High Potency Laboratories
  • Solid State R&D Laboratories 
  • cGMP Analytical Laboratories 
  • Pre-Formulation & Formulation Laboratories 
  • cGMP Kilo Laboratories 
  • cGMP Manufacturing Plant - DS & DP 
  • cGMP Warehouse 
  • cGMP Stability Chambers & Testing Services

Content

  • Challenges in ADC Production – Consolidating Operations Under One Roof

    Antibody Drug Conjugates (ADC) production comes with inherent challenges owing mainly to the toxicity of highly potent payload or warhead used in the production process. In this whitepaper, Eurofins CDMO Alphora demonstrates developed and validated processes to mitigate risks associated with cross-...
Eurofins CDMO
Eurofins CDMO
2395 Speakman Drive
Suite 2001
Mississauga, Ontario L5K 1B3
Canada
Phone: 905-403-0477
Fax: 905-403-8744
Website: alphoraresearch.com

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