Stability Testing & Storage

OVERVIEW

Catalent Benefits      Catalent Services       Catalent Capabilities

Catalent offers release testing, stability testing, stability storage and consulting services in a state-of-the-art facility with comprehensive expertise in the areas of pharmaceutical, biopharmaceutical and combination products. Catalent’s stability services focus on the delivery of quality stability data to support every stage of the product development lifecycle. Our stability studies support all phases of drug development.

• Early development stability
• Excipient compatibility (binary or trial formulations)
• Material compatibility
• Clinical stability
• Predictive stability
• Comparator stability
• Registration stability
• In-use stability
• Commercial stability
• Thermal cycling, freeze-thaw and shipping studies

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CATALENT BENEFITS

Our experienced stability staff can design stability protocols to fit your product development needs, execute your stability study and deliver to you stability data in the format of

• We design the protocol based on a clear understanding of the critical quality attributes of the API or drug product, the clinical phase, the intended market and packaging information.  The use of bracketing or matrixing can be incorporated into the protocol design when appropriate.
• Our execution has the project critical milestones in mind.  Rush testing is available to support critical decisions or regulatory filings.
• Stability results can be issued in your choice of forms as: certificate of analysis at each time point, in an accumulated summary table or entered directly into the customer’s LIMS systems.
• Stability data trending and expiration dating can be done as part of the complete stability package.
• We also offer testing for stability samples stored at other facilities and we provide storage for contingency and retain samples.

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CATALENT SERVICES

We offer a wide range of analytical services:

• Protocol Designs
• Long-Term Stability Testing
• Accelerated Stability Testing
• Drug Substance Stability Testing
• Commercial Product Stability Testing
• Comparator Stability Testing
• Formulation Evaluation Stability Testing
• Statistical Analysis and Data Trending
• Forced Degradation Studies
• Photostability
• Temperature Cycling

We can accommodate a wide range of dosage forms including:

• IR and ER Tablets
• Soft and hard capsules
• Injectable solutions
• Lyophilized products
• Oral solutions and suspensions
• Over-encapsulated comparator products
• Combination products (implants, stents, intra uterus rings, intra vaginal rings)
• Ophthalmics
• Inhalation products (DPI and nasal products)

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CATALENT CAPABILITIES

• Storage conditions
  • Approximately 70,000 cubic feet of storage area over a broad range of storage conditions.
  • Each stability chamber operating independently with its own temperature and, where applicable, humidity controls
  • All storage chambers continuously monitored by a Kaye Monitoring System and a hardwired security system
  • Temperature and humidity setpoint windows at 2 degrees C and 5% RH, respectively
  • All storage chambers fully operational on full generator backup within 6 seconds of power failure
  • Available storage conditions include:
• Photostability
  • Light exposure/temperature control
• Chamber qualifications
  • Kaye Monitoring System (out-of-range alarms and notification)
  • Full generator backup
  • Backup water system
• Types of sample storage
  • Drug product
  • Drug substance
  • Placebo
  • Comparator drug product
  • Controlled drugs
• Available storage conditions