Pharmaceutical CDMO And Contract Manufacturing Services

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 experts to explore how our pharmaceutical manufacturing solutions can align with your drug development needs.

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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.

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

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)

• Dissolution and disintegration
• Moisture analysis (Gravimetric and Karl Fischer [KF] titration)
• Spectroscopy (Ultraviolet/Visible [UV/VIS] and Infrared [FTIR])
• Total Organic Carbon (TOC)
• Viscosity
• Particle Size Analysis
  • Malvern
  • Horiba
  • AccuSizer (USP<788>)

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.