MANUFACTURING AND ANALYTICAL SERVICES
We have tested or manufactured almost all available dosage forms on the market. Our contract manufacturing team is ready to support you for validation, commercial batches, or controlled substances. Analytical services include development and validation of methodologies, and a range of product-release testing.
Altasciences’ CDMO provides contract manufacturing and analytical services to the pharmaceutical industry, including formulation development, Phase I through commercial manufacturing, and ICH stability testing.
All manufacturing processes are performed in our purpose-built facility where we have tested or manufactured almost all available dosage forms on the market, including liquid, powder-filled and over-encapsulated capsules, nano-milled suspensions, creams, gels, powders, and terminally sterilized injectables. We handle APIs/HPAPIs from discovery to commercialization, and offer you expert and efficient pharmaceutical contract manufacturing and analysis.
Under one operational structure, and with a dedicated single Program Manager for each project, Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions to offer an integrated/synchronized approach to CRO and CDMO services. From lead candidate selection to clinical Phase II, we integrate bioanalytical assay development and validation, nonclinical safety evaluation, formulation development, clinic-ready manufacturing, on-demand clinical pharmacy, and clinical testing to proof of concept.
Consult our Fact Sheet, watch our video or visit our Resource Library.
OUR FACILITY
30,000-sq.-ft. facility
- 30,000-sq.-ft. facility
- 9,500-sq.-ft. warehouse
- 3,300-sq.-ft. manufacturing area
- 2,500-sq.-ft. segregated ISO7/8 manufacturing area (capable of handling potent compounds)
- 1,500-sq.-ft. R&D formulation lab
- 3,000-sq.-ft. analytical lab
OUR MANUFACTURING SERVICE OFFERING
Product Development and Manufacturing Capabilities
- Formulation and development
- Process optimization
- GMP clinical supply manufacturing (Phases I to IV)
- Scale-up and engineering batch manufacturing
- Validation batch manufacturing
- Commercial batch manufacturing
- Dosage ytpe and process capabilities
Controlled Substance Manufacturing and Testing Capabilities
- DEA Manufacturing License (Schedules I to V)
Development and Validation of Critical Methodologies
- Cleaning methods for the detection of API on manufacturing equipment
- API methods for assay/related substance
- Finished dosage products (assay/degradation, dissolution)
- Stability testing
ICH Environment Stability Chambers
- Controlled substance testing
Dosage Type and Process Capabilities
- High-performance liquid chromatography (HPLC) and ultra performance liquid chromatography (UPLC)
- Dissolution and disintegration
- Moisture analysis (Gravimetric and Karl Fischer [KF] Titratron)
- Spectroscopy (Ultraviolet/Visible [UV/ VIS] and Infrared [FTIR])
- Total Organic Carbon (TOC)
- Viscosity
- Particle Size Analysis
- Malvern
- Horiba
- AccuSizer (USP<788>)
Additional Client Support Services
Facility expansion capabilities, including dedicated space and equipment, as required to meet project demands.
- Man-in-plant
- Perform supplier audits
RESOURCE LIBRARY
- Webinar: Overcoming the Challenges of Manufacturing and Clinical Trials presented by Ben W. Reed, BS, Vice President, Manufacturing; Kevin Kirkcaldy, B.Pharm., MBA, Pharm.D., Pharmacy Manager; Dennis A. DiBiagio, BS, RPH, Vice President, Business Development; Todd Janssen, RPH, Pharmacy Director; and Ingrid Holmes, Vice President, Global Clinical Operations
- Podcast: Altasciences’ Manufacturing Solutions presented by Ben W. Reed, BS, Vice President, Manufacturing and Steve L. Schweibenz, President, Manufacturing
- Podcast: High-Potency Manufacturing Solutions presented by Ben W. Reed, BS, Vice President, Manufacturing and Shawn Connaghan, VP, Quality Assurance
- Podcast: Liquid-Filled Capsules Solutions presented by Ben W. Reed, BS, Vice President, Manufacturing and Scott Myslinski, Manufacturing Manager
- Podcast: Consultant Series: Securing VC Funding and Drug Manufacturing Consulting with Theresa Johnk, CEO, BioPharma Connections
For more information on our manufacturing and analytical services, visit our website today.