Pharmaceutical Development, Manufacturing, and Analytical CDMO
Altasciences' mission is to provide contract manufacturing services that simplify the logistics of your drug development programs, saving you time and money, and getting your products to market fast.
Our fully qualified, FDA-inspected facility features an analytical lab, R&D formulations lab, multiple manufacturing suites, and a warehouse. We are also equipped with segregated and dedicated Grade C cleanrooms for potent handling capabilities, where we handle APIs/HPAPIs from formulation through commercial scale.
All our CDMO pharmaceutical manufacturing operations take place on a single campus with analytical, manufacturing, and cGMP warehouse capacity.
OUR CDMO PHARMACEUTICAL SOLUTIONS
Our team offers drug development, manufacturing, and analytical services, including formulation development, Phase I through commercial manufacturing, and ICH stability storage and testing. We also provide analytical method development, qualification, and validation, as well as finished product and release testing. We have formulated, tested, and/or manufactured nearly every currently available pharmaceutical dosage form on the market, including liquid- and powder-filled capsules, over-encapsulated capsules, nanomilled suspensions, creams, gels, powders, and terminally sterilized injectables.
YEARS OF COMBINED EXPERIENCE
LICENCE FOR SCHEDULE I-V
Our product development and manufacturing capabilities include:
- Formulation development and manufacture for your API, from discovery through commercialization
- Cost-effective, flexible optimization experience from small prototype batches to commercial scale
- In-house analytical testing to drive and support formulation success
- Receipt, storage, manufacturing, release, and distribution capabilities
- Phase I, II, and III clinical supply and commercial pharmaceutical manufacturing services
- DEA License for Schedule I-V, including pallet positions for Schedule III-V, and vaults for Schedule I‑II
- Environmental monitoring system
- Continuous monitoring of temperature, humidity, and pressure with real-time notification
- Clinical packaging
- Bottle and blister packaging capabilities
- Turnkey pharmaceutical contract manufacturing solutions
- Package design capabilities
- Primary and secondary packaging
- Additional client support services through facility expansion capabilities, including dedicated space and equipment, as required to meet project demands
- Liquid-filled capsulesLiquid-filled capsulesLiquid-filled, two-piece capsules present pharmaceutical and nutritional supplement scientists with a tool to effectively formulate poorly soluble drugs and supplements, while reducing development time and costs.
- Powder-Filled CapsulesPowder-Filled CapsulesFrom formulation development, to clinical studies and commercialization, we ensure a successful path to market.
- Over-Encapsulation/Blinded Study MaterialsOver-Encapsulation/Blinded Study MaterialsOver-encapsulation involves the blinding of a solid dosage form, such as a capsule or tablet into a capsule shell.
- Potent Handling CapabilitiesPotent Handling CapabilitiesThe safe manufacturing of products containing potent active pharmaceutical ingredients (APIs) requires both hardware and software that adequately protect personnel and the environment, including the facility.
- Wet Nano Milling and Liquid Vial FillingWet Nano Milling and Liquid Vial FillingWith the latest, state-of-the-art equipment train, including a Netzsch DeltaVita 15-300 mill for the wet milling of API to reduce particles to nano size, come to us for your vial filling needs.
- Terminal SterilizationTerminal SterilizationInjectable drugs must meet high standards of quality, purity, and sterility. Our Grade C suites allow us to develop injectable drug products that can be terminally sterilized after manufacture.
- Other ManufacturingOther ManufacturingOur team has developed formulations, designed equipment trains, validated processes, developed and validated analytical methods, and obtained regulatory approvals for nearly every pharmaceutical dosage form.
For additional information on our drug manufacturing solutions, consult the following resources:
Analytical Lab and Testing
Altasciences offers contract HPLC/UPLC method development and validation, raw material, in-process, finished product, and stability testing for your drug development programs. We take pride in the development of robust and rugged analytical procedures to ensure the quality of your products, and qualification and validation of analytical procedures to meet both your requirements and those of regulatory agencies worldwide.
Our analytical lab and testing service offering includes:
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)
- ICH environment stability chambers
Controlled Substance Testing
- DEA Analytical License (Schedules I-V)
Excipient and Active Pharmaceutical Ingredients (APIs)
- Compendial method verification and validation studies
- Monograph release testing per the USP, EP, BP, and JP
Drug Product Release Testing
- High-performance liquid chromatography (HPLC) and ultra performance liquid chromatography (UPLC)
- Dissolution and disintegration
- Moisture analysis (Gravimetric and Karl Fischer [KF] titration)
- Spectroscopy (Ultraviolet/Visible [UV/VIS] and Infrared [FTIR])
- Total Organic Carbon (TOC)
- Particle Size Analysis
- AccuSizer (USP<788>)
- API, Excipient, and Packaging ComponentsAPI, Excipient, and Packaging ComponentsWe provide all necessary United States Pharmacopeia/National Formulary (USP/NF) and European Pharmacopeia (EP) testing for materials received, with a rapid release from our analytical department.
- Drug Product Release and Stability TestingDrug Product Release and Stability TestingWe offer a full array of small molecule analytical techniques to evaluate your API and drug products.
- Method Development, Qualification, and ValidationMethod Development, Qualification, and ValidationWe have the necessary equipment and experience to perform validations of analytical methods in any formulation, valuable to reduce the development time required to get you to a validated method.
- On-Site, ICH Stability Storage and TestingOn-Site, ICH Stability Storage and TestingEquipped with state-of-the-art analytical laboratories and on-site, ICH-compliant stability chambers, our laboratory is ready to handle all your needs.
Pharmaceutical Contract Manufacturing - FAQs
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. Contract pharmaceutical manufacturing services typically 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.