PHARMACEUTICAL CONTRACT MANUFACTURING AND ANALYTICAL SERVICES
Pharmaceutical contract manufacturing services and facilities that simplify your drug programs. We have tested or manufactured almost all available dosage forms on the market, including liquid and powder-filled capsules, nano-milled suspensions, creams, gels, powders, tablets, and terminally sterilized injectables. Our expert pharmaceutical 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.
Pharmaceutical Contract Manufacturing Services
Altasciences’ pharmaceutical contract development manufacturing organization (CDMO) has deep expertise and capabilities across a range of dosage forms. Located in the heart of the United States’ biopharmaceutical sector in Harleysville, Pennsylvania. The training we provide our pharmaceutical contract manufacturing and analysis workforce is second to none, ensuring that our team has the skills to complete your project to the highest standards in the industry. All of our processes are supported by U.S.- and EU- compliant cGMP procedures in conjunction with a robust on-going training program. Our facility and equipment are designed, built, and fully qualified to meet and/or exceed all current regulations and guidance. We are agile, flexible, and always available.
Our 30,000-square-foot GMP facility features an analytical lab, R&D formulations lab, multiple manufacturing suites, including segregated and dedicated potent handling capabilities, and a warehouse.
Our pharmaceutical contract manufacturing expertise includes liquid and powder-filled capsules, nano-milled suspensions, creams, gels, powders, tablets, and terminally sterilized injectables, which are manufactured in our purpose-built facility with state-of-the-art Grade C cleanrooms. We handle APIs/HPAPIs from formulation through commercial scale and offer analytical method development, qualification, and validation for the in-process and finished product, as well as ICH stability storage.
LICENSING AND REGISTRATIONS
- Pennsylvania Dept. of Health Prescription and Non-Prescription Drug and Medical Device Manufacturer, Distributer and Wholesaler
- U.S. Food and Drug Administration Drug Establishment FEI 3007884119/Labeler code 75969
- Analytical DEA License Number RA0396831 for Schedules I - V
- Manufacturer DEA License Number RA0403078 for Schedules I - V
- FDA Food Facility Registration Number 13781101748
- All FDA Inspections have yielded approvable recommendations with no 483s
- EU QP Inspected
Contract formulation development, clinical supply, and commercial manufacturing with multiple dosage solution offerings
Contract HPLC/UPLC method development and validation, raw material, in-process, finished product, and stability testing
Frequently Asked Questions (FAQs) for Pharmaceutical Contract Manufacturing
What is a CDMO?
CDMO stands for Contract Development and Manufacturing Organization. It describes a company that serves pharmaceutical companies on a contract basis to provide comprehensive services from drug development through drug manufacturing. Pharmaceutical contract manufacturing is a key support service that CDMOs provide.
Why do we need pharmaceutical contract manufacturing and analysis?
Critical components of a drug development program include the capacity to manufacture and analyze the product being developed. We offer contract pharmaceutical manufacturing services that include all the necessary processes, conducted under rigorous conditions, to ensure the product is developed according to regulations.
What is pharmaceutical formulation development?
Formulation development studies are a fundamental process performed by pharmaceutical contract manufacturing experts to determine the optimal dosage form, composition and manufacturing route for product development. Reliable formulation development serves to optimize drug delivery performance and product stability.
What is clinical manufacturing?
Clinical manufacturing is a service provided by a CDMO to ensure that sufficient and appropriate drug product is created and tested for clinical trial purposes, and beyond, to commercialization. Pharmaceutical contract manufacturing services offered by Altasciences include GMP clinical supply manufacturing (Phases I-IV), scale-up and engineering batch manufacturing, validation and commercial batch manufacturing, as well as many supporting and complementary services.