Pharmaceutical CDMO and Contract Manufacturing Services
Altasciences' mission is to provide contract development and manufacturing services that simplify the logistics of your drug development programs, saving you time and money, and accelerating speed to market.
Our fully qualified, FDA-inspected manufacturing facility features an analytical lab, R&D formulations lab, multiple manufacturing suites, and a cGMP warehouse, all on a single campus. We are also equipped with segregated Grade C cleanrooms for potent handling capabilities, where we handle APIs/highly potent APIs from formulation through commercial scale.
Connect with our seasoned CDMO experts to explore how our pharmaceutical manufacturing solutions can align with your drug development needs.
OUR PHARMACEUTICAL CDMO SOLUTIONS
Our team offers drug development, manufacturing, and analytical services, including formulation development, Phase I through large scale commercial manufacturing, and ICH stability storage and testing, to pharmaceutical and biotech companies worldwide. We also provide analytical method development, qualification, and validation, as well as finished product and release testing. Using advanced manufacturing processes, we have formulated, tested, and/or manufactured nearly every currently available pharmaceutical dosage form on the market, including tablets, liquid- and powder-filled capsules, over-encapsulated capsules, nanomilled suspensions, creams, gels, powders, and terminally sterilized injectables.
YEARS OF COMBINED EXPERIENCE
ON-TIME DELIVERY
LICENCE FOR SCHEDULE I-V
DRUG PRODUCT Manufacturing
Our contract development and manufacturing solutions include:
- formulation development and manufacturing of your drug substance, from early stages through commercialization
- Cost-effective, flexible optimization experience from small prototype batches to commercial scale
- In-house research and development and analytical testing to drive formulation success
- Receipt, storage, manufacturing, release, and distribution capabilities
- Phase I, II, and III clinical supply, up to large scale pharmaceutical manufacturing
- 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
- Package design capabilities
- Primary and secondary packaging
- Clinical packaging
- Bottle and blister packaging
- Turnkey pharmaceutical contract manufacturing solutions of high quality products
- Additional client support services through facility expansions, including dedicated space and equipment, as required to meet project demands
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FORMULATION DEVELOPMENTFORMULATION DEVELOPMENTFormulation development of active pharmaceutical ingredients is essential for achieving therapeutic efficacy and ensuring patient safety in upcoming clinical trials. -
TABLET MANUFACTURINGTABLET MANUFACTURINGUsing cutting-edge equipment and methodologies, our manufacturing specialists ensure the successful development of your tablets— from small- to commercial-scale batches. -
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 development and manufacturing services, 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)
Stability Testing
- 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)
- Gas chromatography (GC)
- Dissolution and disintegration
- Moisture analysis (gravimetric and Karl Fischer [KF] titration)
- Melting point determination
- Residue on ignition
- Spectroscopy (ultraviolet/visible [UV/VIS] and infrared [FTIR])
- Total organic carbon (TOC)
- Viscosity
- Particle size analysis
- HORIBA analyzer
- AccuSizer® (USP<788>)
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APIs, Excipients, and Packaging ComponentsAPIs, Excipients, 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. -
Pharmaceutical Product Release TestingPharmaceutical Product Release 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. -
ICH Stability Storage and TestingICH 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.
INTEGRATED CRO/CDMO SERVICES FOR RIGOROUS AND FASTER DRUG DEVELOPMENT
We can significantly accelerate your drug development timeline and provide you with a seamless transition from one drug development phase to the next, with our fully integrated CRO/CDMO services—all centralized and managed right here at Altasciences.
Once we have formulated your drug product, our preclinical team will evaluate their safety profile. Concurrently with these safety assessments, we develop a reproducible and scalable manufacturing process, detailing the appropriate equipment and establishing relevant parameters.
Once safety testing is completed and before clinical trials are initiated, our regulatory team will compile your preclinical data, clinical trial protocols, and information about the manufacturing process to be included in your Investigational New Drug (IND) application.
If the results of the clinical trials we then conduct are positive, our experts will scale up and optimize the manufacturing process to prepare your drug product for commercialization.
Because we have a holistic view of your program, we can anticipate and resolve any situation that might impact your project, thus reducing complexities, mitigating risks, condensing timelines, and enabling cost savings.
For additional information on our analytical lab and testing solutions, consult the following resources:
- Fact Sheet: Pharmaceutical Analytical Services Fact Sheet
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.