USA/Canada

Eurofins CDMO Alphora Inc.

Eurofins CDMO Alphora Inc., operating as part of the Eurofins CDMO network of companies provides Active Pharmaceutical Ingredient (API) and DP (Drug product) technology development services for the scale-up of complex small molecules with pharmaceutical and biotechnology applications, including high potency compounds.

These FDA inspected and approved Contract Development Manufacturing Organization (CDMO) facilities include GMP Kilo Laboratories, GMP Plant operations, Organic and Analytical Laboratories, and supporting Quality Control and Quality Assurance/Compliance functions. A separate suite is used for the handling of highly potent compounds. Most recently a new Solid State Research & Development (SSRD) and Pre-formulation and Formulation Laboratories have come online as part of a new Drug Product Operations suite for a total of 88,500+ ft² across 4 locations operating as a contiguous site.

An additional campus-style building is under construction to provide additional support and capacity for an active pipeline of projects.

Founded in 2003, Eurofins CDMO Alphora Inc.  has established a key management team with over 275 years of combined experience, driving a highly talented team with notable success in developing and successfully implementing API technologies for hundreds of pre-clinical and clinical compounds.

Services: 

• Process Development
• DoE and QbD
• Analytical Validation and Development
• Stability Testing
• Gram to Kilogram synthesis
• GMP and non-GMP
• High Potency
• Fast Track services
• Flow Chemistry
• Solid State Research & Development
• Drug Product Operations (Pre-Formulation & Formulation)
• Regulatory Support services (ANDA, DMF)

Eurofins Advantar

Eurofins Advantar provides analytical and formulation development expertise with respect to virtually all dosage forms and API’s ranging from small molecules (organic and inorganic) to peptides, proteins, DNAs and RNAs. Our GLP and cGMP-compliant lab services encompass Toxicology Test Article preparation and testing, Pre-formulation, Formulation Development, Analytical Method Development & Validation, QC release and stability, Clinical Trial Material Labeling/Packaging/Logistics and Regulatory/Technical Consultancy. Eurofins Advantar has also added 1,500 ft² of non-sterile manufacturing capabilities.

• Formulation Development & Optimization
• Analytical Development & Validation
• GMP Manufacturing (Sterile and non-sterile)
• QC Release and Stability Testing
• Clinical Trial Material Labeling, Packaging, and Logistics
• Technical & Regulatory Consultancy
• Early Phase Development Solutions

Accreditations/Certifications/Registrations:

• FDA audited
• GLP

Eurofins BioPharma Product Testing Columbia, Inc.

Eurofins BioPharma Product Testing Columbia (formerly known as EAG Laboratories) offers the pharmaceutical industry an analytically focused CRO with deep experience in method development, program design and complex study execution. A true development CRO, we deliver comprehensive CMC analytical support including multi-disciplinary, multi-technique analytical method development and validation, complete stability program management and in-depth extractables and leachables expertise—plus in-house custom synthesis and cGMP radiolabeling services. Eurofins BioPharma Product Testing Columbia also offers specialized materials testing to support supply chain and packaging initiatives, and the full range of environmental fate, metabolism and toxicology studies required to evaluate a pharmaceutical’s potential environmental impact. 

TECHNICAL SERVICES

• Method development and validation (drug and drug product)
• Stability testing and storage
• Protein characterization
• Bioassays and cell-based potency assays
• Dose formulation testing
• Extractables and leachables programs
• Container/closure qualification
• Impurity isolation, ID and characterization
• Reference standard synthesis, characterization and storage
• QC/release testing
• Custom synthesis and radiolabeling (including cGMP)
• Environmental risk assessments
• Specialized materials testing and failure analysis