Manufacturing and Analytical Services

  • Manufacturing and Analytical Services
  • Formulate Your Drug Compound for Optimal Preclinical and Clinical Study Outcomes

     

    Choose Excellence. Choose Success.

    A well-designed formulation in preclinical studies ensures accurate dosing, stability, and safety of drug candidates, and provides essential data for regulatory submissions―contributing directly to the translational success of the drug compound from the preclinical to the clinical phase.

    To successfully formulate your simple and complex APIs, our 64,000-sq.-ft., cGMP manufacturing facility in Philadelphia is equipped with cutting-edge equipment and processes that allow our scientists to provide:

          •   optimal drug solubility and bioavailability;
          •   dose accuracy and uniformity;
          •   PK/PD parameters;
          •   data on stability and shelf life; and
          •   optimal dosage form and route of administration.

    Don't leave the formulation of your drug compound to chance.

    Speak with one of our experts today to discuss your project, and let's bring your drug candidate one step closer to market.

     

     

    Related resources that may interest you:

    •   Webpage: Comprehensive Manufacturing and Analytical Testing Services
    •   Scientific Journal: Critical Considerations in High Potency Manufacturing
    •   Infographic: Choosing the Optimal Dosage Form for Your API



     

    Get Improved Bioavailability and Stability With This Dosage Form

    The choice of dosage form in drug development depends on various factors, such as the properties of the API, the therapeutic goals, and regulatory considerations. Taking those factors into account, liquid-filled, hard-shell capsules (LFHCs) offer several advantages compared to other traditional solid oral dosage forms, such as:

    •    improved solubility and bioavailability
    •    enhanced stability
    •    customizable release profiles
    •    flexibility of formulation
    •    faster onset of action
    •    potential for combination therapies
    •    improved patient compliance in clinical trials

    To learn more about the application of LFHCs in drug development, and how they can accelerate your timeline, consult the resources below.

    eBook: The Applications of Liquid-Filled Capsules in Pharmaceutical Development
    Interview: Benefits of Using Liquid-Filled Capsules in Clinical Trials
    Case Study: Rapid Development of a Liquid-filled, Hard-Shell Capsule Formulation of Cannabidiol


    To find out if your compound is suitable for LFHCs, speak with one of our experts today.
      

    Infographic―Discover the Optimal Dosage Form for Your Molecule

     

    A Quick Guide 

    We’ve received a lot of questions about drug formulation and development over the years, but these are the most common:

    •    What’s the best dosage form for my molecule? 
    •    Which will yield data from clinical trials faster? 
    •    Which will safely get my product to market fastest?

    The answer to all is “It depends on your molecule!”. Take a look at this infographic for help determining whether tablets or liquid-filled, hard-shell capsules are most suitable for your specific molecule, and let’s plan the next step.   

    Have questions? Speak with one of our experts.

    Related resources that may interest you:
    eBook: Applications of Liquid-Filled Capsules in Drug Development
    Podcast: Ensuring the Successful Manufacture of Clinical Trial Supply
    Webpage: Comprehensive Manufacturing and Analytical Testing Solutions

    Choosing the Optimal Dosage Form for Your Molecule

    Angel Reyes Joins Altasciences as General Manager of CDMO Services

    Laval, Québec, Friday, October 6, 2023Altasciences is pleased to welcome AngelAngel Reyes Reyes as General Manager, Contract Development and Manufacturing Organization (CDMO) Services. 

    Angel joins Altasciences having previously been the Director of Operations at Catalent. He brings to Altasciences over a decade of experience in management and supervisory roles for manufacturing operations and supply chains, having demonstrated an impeccable standard in ensuring adherence to compliance and cGMP policies.

    Angel graduated with a bachelor’s degree in chemistry from the University of Eastern Kentucky and began his career as an analyst before stepping into the role of Pharmaceutical Scientist, where he was responsible for the manufacturing and preparation of commercial solid dosage forms. 

    “Angel’s scientific knowledge and wealth of experience gained over years in managing manufacturing operations, combined with his ability to find innovative solutions and improve day-to-day operations, makes him a valuable addition to the CDMO team. I am confident he will have a significant impact on the organization,” said Ben Reed, Executive General Manager, CDMO Services, Altasciences. 

    As General Manager, Angel is responsible for overseeing day-to-day operations in analytical and manufacturing services, and managing client relations.
     

    About Altasciences
    Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. To learn more about Altasciences, visit altasciences.com.
     
    Julie-Ann Cabana
    Altasciences
    +1 514 601-9763
    jcabana@altasciences.com  
     

    Critical Considerations for the Manufacture of Highly Potent Compounds

     

    The demand for highly potent active pharmaceutical ingredients (HPAPIs) has been increasing over the past decade, mainly driven by oncology research.

    In this issue, we examine the intricacies of manufacturing HPAPIs and associated drug products, including a review of the relevant guidance, classification systems, and safety processes. We also explore how CDMO facilities, equipment, and procedures for HPAPIs should be adapted to ensure safety, compliance with GMP regulations, and the successful manufacture of your product.

    READ THE ISSUE

    Related resources that may interest you:

    Webpage: High Potency Manufacturing Services
    Webinar: Nanosuspension Formulations for Poorly Soluble Drugs
    Interview: Handling Your Highly Potent APIs and Controlled Substances
     

    Manufacturing With a Highly Potent API for an Ophthalmic Indication

    Altasciences' Facilities: Moving in Unison

    Getting to the Heart of Science with Amber malloy

    Amber Malloy, Analytical Associate III, Altasciences
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