Manufacturing and Analytical Services

  • Manufacturing and Analytical Services
  • This is Where the Magic Happens

     

    Discover Our R&D and Formulation Laboratories and Services

    Analytical testing plays a pivotal role in all phases of pharmaceutical development. No matter how complex your molecule is, our scientists formulate it and use robust analytical instrumentation and processes to ensure the quality of your in-process or finished drug product, and rapidly advance it to the next phase of development.

    Our analytical services include:

    • Method development, qualification, and validation
    • Drug product release testing
    • On-site ICH stability storage and testing
    • Controlled substance testing (DEA manufacturing and analytical license, Schedules I-V)
    • Excipients and active pharmaceutical ingredients (APIs)
    • Packaging components

    Take a virtual tour of our R&D and formulation laboratories to see where the magic happens!

    Manufacturing Facility Tour

    Want to benefit from our services? Book a consult today.

    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.

     

    Optimizing Drug Formulations for Successful First-in-Human Clinical Trials

     

    Ensure a Smooth Transition from Formulation to Clinical Trials

    Altasciences supports your formulation and drug development needs for preclinical safety testing, from discovery through first-in-human (FIH) clinical trials, for all dosage forms, such as oral liquids, powders, capsules, and injectables.

    Our integrated approach combines formulation development, cGMP manufacturing and release testing, as well as clinical testing functions/workflows. One of the biggest benefits of this seamless offering is that our clinical trial teams work closely with the scientists involved in the formulation and manufacturing process, and are able to evaluate and optimize new formulations in the clinic, based on real-time human data. This collaboration and data sharing between our teams leads to shorter timelines, less risk, reduced costs, and improved flexibility.

    Learn more about our expertise with both simple and complex formulation development, including those with highly potent APIs and solubility/bioavailability challenges. 

    Scientific Journal Q&A Video

    Altascientist issue 17 - First-in-Human

    Video - Quick Chat with Andrew Buis

     

    Questions? Speak with one of our experts.

    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 Real Reason Why Sponsors Choose Liquid-Filled Capsules Over Tablets in Drug Development

     

    Applications Of Liquid-Filled Hard‑Shell Capsules In Drug Development

    Often selected for drugs with poor solubility/bioavailability, liquid-filled hard-shell capsules (LFHCs) have various applications and specific benefits over other solid oral dosage forms in different phases of pharmaceutical development.

    In this issue of The Altascientist, you will find:

    • Applications of LFHCs 
    • Advantages of LFHCs over other solid oral dosage forms
    • The process for developing an LFHC formulation 
    • The role of excipients 
    • CASE STUDY: The Rapid Development of an LFHC Formulation of Cannabidiol

    The Altascientist issue 28 - Liquid-Filled Capsules

    Contact us to optimize your drug development by using liquid-filled capsules.

    Got a few more minutes? Check these out. 


    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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    Whether you are embarking on Preclinical safety testing, Phase I clinical trials, or need manufacturing services f

    Still Using Tablets in Your Clinical Trials? Consider Changing to a Better Option.

     

    Accelerate Your Clinical Trials With This Dosage Form

    With tablets presenting numerous drawbacks, liquid-filled capsules (LFCs) are becoming the optimal choice for clinical trials. Their benefits include:

    • Ease of scalability from preclinical to clinical to commercial volumes
    • Quick dose adjustments
    • Faster dissolution and absorption
    • Less required stability studies 

    LFCs are most suitable for drugs with complex formulations, low-dose requirements, poor solubility, or highly potent active pharmaceutical ingredients (APIs). Clients with such drug profiles substantially accelerated their drug development process using LFCs for early phase clinical trials, resulting in reduced costs.

    Where Do We Come In?

    Altasciences’ state-of-the-art cGMP manufacturing and analytical facility in Philadelphia has a team of experienced scientists to support you through your entire drug development process, from pre-formulation to clinical trials and beyond. Our advanced equipment includes cutting-edge liquid-filling, binding, and sealing machines, ensuring an impressive 97% right-first-time (RFT) batch release success rate.

    Consult our resources for further details on how you can benefit from using LFCs in your clinical trials.

    eBooklet (PDF) Infographic (PDF) Quick Chat (Video) Client Case Study (PDF)
    eBooklet (PDF) infographic (PDF) Quick Chat (video) Client Case Study (PDF)

    Ready to accelerate your drug development? Speak with one of our experts.

    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.

    Case Study―Product Manufacturing and Analytical Testing for an Ocular Client

    Reduce Your Drug Development Costs and Delays

     

    Benefit from Partnering with a Single CRO/CDMO Partner―From Formulation to Preclinical to Clinical

    The drug development journey often involves working with different CRO and CDMO partners. But there’s a simpler, more efficient solution!

    Altasciences’ fully integrated, end-to-end offering means seamless transition from prototype formulation through preclinical testing, to early phase clinical trials, and manufacturing. This reduces complex handoffs, communication errors, and delays.

    Discover how we support you through each phase of your drug development.

    Video - Manufacturing & Analytical Services

    Contact us to get started.

    Related pages:

    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.

    Formulation to Clinic―Navigating the Complexities of Ophthalmic Drug Development

     

    Helping You Navigate the Complexities of Ophthalmic Drug Development

    Ophthalmic drug development comes with a unique set of challenges and complexities. To maximize your chance of success, it is best to rely on a drug development partner with regulatory knowledge, scientific and technical expertise, and a thorough understanding of the market in this growing therapeutic area.

    Altasciences’ clients benefit from working with a single CRO/CDMO partner, from prototype formulation through preclinical testing, to early phase clinical trials, and manufacturing. This could mean up to 40% in both time and cost savings.

    Learn about the key considerations and critical steps in each phase of ophthalmic drug development, including case studies, in this issue of The Altascientist

    The Altascientist issue 27 - Ophthalmic

    Have questions? Speak with one of our experts.

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    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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