Manufacturing and Analytical Services

  • Manufacturing and Analytical Services
  • Thanks to updated screening methods and bioavailability enhancements, poorly soluble molecules comprise 70% to 80% of the small molecule products entering the drug development pipeline today. Since poorly soluble drugs are difficult to formulate as tablets, formulation scientists are looking to two-piece, liquid-filled hard-shell capsules as a solution.

    FDA Says Use Terminal Sterilization Over Aseptic Manufacturing. Find Out Why.

     

    Terminal sterilization is the most effective way to reduce the chances of microbial contamination and provides a higher level of sterility assurance to finished drug products. It is also less complex, less costly, and more easily reproducible than aseptic manufacturing.

    Discover the full range of benefits by viewing the webinar on-demand.

    Topics include:

    • Differences between aseptic processing and terminal sterilization
    • Common misconceptions about terminal sterilization
    • Preferences and expectations of regulatory agencies
    • How to evaluate your product’s compatibility

    Case study also included!

    VIEW WEBINAR

    Webinar - Advantages of Terminal Sterilization Over Aseptic Manufacturing

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.​​​​

    Things You Never Knew ― Benefits of Working With a Drug Development Consultant

     

    The importance of working with a drug development and manufacturing consultant

    In this podcast with Dr. Daniel E. Levy, we uncover the key considerations when putting together your drug development and manufacturing program, the importance of securing a drug development and manufacturing expert, and the most important things to look for in an integrated CRO/CDMO partner.

    Listen to the podcast!

    Podcast - The Importance of a CDMO Consultant

     

    You may also be interested in the following:

    WEBINAR ― Join Altasciences and Prince Terminal Sterilization for a complimentary webinar to find out why the FDA and EMA recommend terminal sterilization over aseptic manufacturing, and its many advantages for your drug products.

    REGISTER NOW

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond. Our experts in pharmaceutical contract manufacturing and analytical testing are ready to support you for formulation, method development and validation, clinical trial supply, and commercial batch manufacturing. We have tested or manufactured almost all available dosage forms on the market, including liquid- and powder-filled capsules, nano-milled suspensions, creams, gels, and terminally sterilized injectables.

    CASE STUDY ― The Rapid Development of CBD Formulations From Scratch for a New OTC Product

     

    Case Study - CannabidiolAltasciences has become the go-to partner for pharmaceutical companies striving to develop safe and effective cannabidiol (CBD) products to address unmet medical needs. With our integrated early phase drug development solutions, we can quickly undertake formulation development and clinical manufacturing of next generation formulations with challenging APIs and controlled substances, such as CBD.

    In this latest case study, our client (Emyria) presented the challenge of developing several oral formulation candidates for CBD from scratch for a new over-the-counter (OTC) product. Learn how we completed the entire project in just over three months!

    DOWNLOAD NOW

    You may also be interested in: 

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    Rapid Development of a Liquid-filled, Hard-Shell Capsule Formulation of Cannabidiol

    The Importance of Customized Analytical Solutions for Your Molecules

     

    Analytical Testing in Pharmaceutical Development

    Analytical testing plays a pivotal role in all phases of pharmaceutical development and is one of the most outsourced services among drug developers today. 

    At Altasciences, we use the latest instrumentation to support your drug development and manufacturing, no matter how complex or challenging your molecule is. Our robust analytical procedures ensure the quality of your raw, in-process, or finished product, and provide method development and validation to meet the ever-evolving requirements of regulatory agencies worldwide.

    We provide you with:

    • Method development, qualification, and validation
    • On-site ICH stability testing and storage
    • Controlled substance testing
    • Excipient and active pharmaceutical ingredients (APIs)
    • Drug product release and stability testing

    Discover our full array of analytical solutions, or speak with one of our experts to get started.

    Let’s chat.

    You may also be interested in:

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    The Value in Working With a Consultant in Your Drug Development Journey

     

    The importance of working with a drug development and manufacturing consultant

    In this podcast with Dr. Daniel E. Levy, we uncover the key considerations when putting together your drug development and manufacturing program, the importance of securing a drug development and manufacturing expert, and the most important things to look for in an integrated CRO/CDMO partner.

    Listen to the podcast!

    Podcast - The Importance of a CDMO Consultant

    You may also be interested in the following:

    WEBINAR ― Join Altasciences and Prince Terminal Sterilization for a complimentary webinar to find out why the FDA and EMA recommend terminal sterilization over aseptic manufacturing, and its many advantages for your drug products. 

    REGISTER NOW

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond. Our experts in pharmaceutical contract manufacturing and analytical testing are ready to support you for formulation, method development and validation, clinical trial supply, and commercial batch manufacturing. We have tested or manufactured almost all available dosage forms on the market, including liquid- and powder-filled capsules, nano-milled suspensions, creams, gels, and terminally sterilized injectables.

    The Advantages of Liquid-Filled Capsules Over Tablets in All Phases of Drug Development

    Getting a Handle on Highly Potent APIs and Controlled Substances

     

    Manufacturing and Handling Highly Potent APIs and Controlled Substances

    With more highly potent APIs (HPAPIs) coming through the R&D pipeline than ever before, it has become increasingly important to partner with the right CDMO to rapidly formulate and manufacture your HPAPIs for preclinical, clinical, and commercial development. 

    In this Quick Chat video with Ben Reed, learn how Altasciences, a fully integrated CRO/CDMO, handles the most challenging drug substances, from early phase development to commercialization, including:

    • Industry-leading technologies used for formulation, containment, and sterilization
    • Seamless shipping and handling of your HPAPIs and controlled substances
    • Safety procedures and protocols

    Watch it now!

    Video - Quick Chat - Manufacturing and Handling You Highly Potent APIs and Controlled Substances

    Have questions? Speak with our experts.

    You may also be interested in the following:


    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    Top 5 Ways Liquid-Filled Capsules Accelerate Your Drug Development

     

    Advantage of Liquid-Filled Capsules in Drug Development

    Choosing the right dosage form for your API can be the key to accelerating your drug development timeline.

    Liquid-filled, hard-shell capsules offer countless benefits over tablets and other solid oral dosage forms, in all phases of drug development ― especially for highly potent or challenging APIs.

    View the infographic to learn more!

    The Benefits of Liquid-Filled Capsules (LFCs)

    Have questions? Speak with one of our experts.

    You may also be interested in:


    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

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