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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.

We provide proof of concept, R&D, clinical and commercial pharmaceutical manufacturing that includes liquid-filled capsules, band/sealing technologies, powder and over-encapsulated capsules, topical formulations, and clinical and blister packaging which are manufactured in our purpose-built facility with ISO 7 and 8 cleanrooms.

FACILITY

Our 30,000-square-foot facility features:

  • 9,500-sq.-ft. warehouse
  • 3,300-sq.-ft. Pharmaceutical contract manufacturing area
  • 2,500-sq.-ft. segregated ISO7/8 manufacturing area (capable of handling potent compounds)
  • 1,500-sq.-ft. R&D formulations lab
  • 3,000-sq.-ft. analytical lab.

We have manufactured and/or tested nearly every currently available pharmaceutical dosage form.

PHARMACEUTICAL CONTRACT MANUFACTURING SERVICES

Product Development and Manufacturing Capabilities
  • Formulation and development
  • Process optimization
  • GMP clinical supply manufacturing (Phases I-IV)
  • Scale-up and engineering batch manufacturing
  • Validation batch manufacturing
  • Commercial batch manufacturing
Controlled Substance Manufacturing Capabilities
  • DEA Manufacturing License (Schedules I-V)
Additional Client Support Services
Facility expansion capabilities, including dedicated space and equipment, as required to meet project demands.
  • Man-in-plant
  • Perform supplier audits
Dosage Type and Process Capabilities
  • Liquid-filled hard shell capsules
  • Capsule banding
  • Particle size reduction (wet milling/nano-milling)
  • Powder blending
  • Powder-filled capsules
  • Over-encapsulation
  • Injectable vial filling (pre-sterilized)
  • Solutions and suspensions
  • Gels and creams
  • Clinical packaging (bottles and blisters)
  • Potent product handling

ANALYTICAL SERVICES

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)
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)
Drug Product Release Testing (cont’d)
  • Spectroscopy (Ultraviolet/Visible [UV/VIS] and Infrared [FTIR])
  • Total Organic Carbon (TOC)
  • Viscosity
  • Particle size analysis
    • Malvern
    • Horiba
    • AccuSizer (USP<788>)
Stability Testing
  • ICH environment stability chambers
Controlled Substance Testing
  • DEA Analytical License (Schedules I-V)

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.

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Working as a flexible, attentive extension of your team, we offer all you need to move your molecule forward.