Manufacturing and Analytical Services

  • Manufacturing and Analytical Services
  • Quickly Advance Your Highly Potent API From Concept to Commercialization

     

    Approximately 25 % of drugs in development worldwide are classified as highly potent active pharmaceutical ingredients (HPAPIs), and present substantial challenges and safety concerns to the pharmaceutical manufacturing industry.

    At Altasciences, handling and developing HPAPIs into finished drug product, such as anti-cancer compounds and narcotics, is one of our core strengths. Our unique expertise, segregated grade C/D clean rooms, safety procedures, and advanced technology allow us to take your potent compounds from concept to commercial scale manufacturing, safely.

    Learn more about our HPAPI handling and manufacturing capabilities here.

    Need help with your HPAPI?

    CHAT WITH AN EXPERT

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

    Let’s Talk Integrated Clinical and CDMO Solutions

     

    Quality and Excellence with Integrated Clinical and CDMO Solutions

    Shawn Connaghan, Executive Vice President of Administration and Quality Management, Manufacturing, discusses how Altasciences’ integrated manufacturing and clinical solutions can benefit your drug development program. 

    Topics covered:

    • Advantages of integrated manufacturing and clinical solutions
    • Quick project start-up
    • Maintaining high-quality standards
    • Adapting to sponsors’ unique needs

    WATCH NOW

    Quick Chat with Shawn Connaghan, Executive Vice President of Administration and Quality Management

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    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

    How Nano Milling Saved Our Client’s Poorly Soluble Compound

     

    Case Study: Nano Milling from Screening to Scale-Up

    Have you ever had a challenging API with poor water solubility and bioavailability, and didn’t know how to improve the formulation? Our client did, and they came to us for help!

    Download our case study to learn how Altasciences determined the suitability of nano milling to increase the drug’s dissolution rate and bioavailability, making sure our client had it ready on time for their first-in-human clinical trial.

    READ CASE STUDY

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    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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. 
     

    Expert Support for Your IND/CTA Requirements

    Partnering with Altasciences for your IND/CTA needs will ensure that your application to regulatory agencies moves forward as smoothly and efficiently as possible. To reach your milestones on time, we recommend setting up a meeting to consult with us at least six months before your required submission date.

    Contact our experts today.

    Altasciences can help you compile the key information necessary to approve your application request, including:

    • Animal pharmacology and toxicology studies to assess safety
    • Manufacturing processes to ensure consistent batches of the study drug
    • Clinical protocols and investigator information to assess tolerance and risk

    For a more detailed discussion of the regulatory planning process, consult our Preclinical Assessment Planning Guide.

    Altasciences’ Proactive Drug Development platform transforms the traditional outsourcing paradigm by providing you with expertly designed, customized roadmaps that seamlessly bring you from lead candidate selection to clinical proof of concept, and beyond.

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    Are You Using the Right Dosage Form for Your API?

     

    Applications of Liquid-Filled Capsules for Challenging APIs in Pharmaceutical Manufacturing

    Liquid-filled, hard-shell capsules (LFCs) offer significant benefits for APIs that present formulation or manufacturing challenges. They are also an attractive option for sustained release products, line extensions, and brand differentiation. Their use is beneficial throughout the different phases of drug development, from preclinical to commercialization.

    Download our white paper to learn more on the process of liquid-filled capsule manufacturing, and to find out if LFCs are the right choice for your API.

    DOWNLOAD WHITE PAPER

    You may also be interested in the following:

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

    Applications of Liquid-Filled Capsules for Challenging APIs in Pharmaceutical Manufacturing

    Nanomilling from Screening to Scale-up

    Tailored Analytical Solutions for Fast Entry into Clinical Trials

     

    Choosing the Right Partner for Your Formulation Needs

    Altasciences’ extensive formulation and manufacturing services, integrated with our early phase drug development offering, spans across the full drug development pathway, from discovery through commercialization. Our scientists have decades of expertise with both simple and complex dosage forms, and a successful track record of formulating molecules and developing the drug products required to support early phase clinical trials.
     
    Discover our full range of analytical services, including: 

    • Drug product release and stability testing
    • Method development, qualification, and validation 
    • On-site, ICH stability storage and testing

    Get a head start on your project ― speak with one of our scientists.
     
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    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

    Which Dosage Form Gets Your Drug to Market Faster?

     

    Liquid-Filled Capsules ― Getting Your Drug to Market, Fast

    Altasciences has developed and manufactured practically every dosage form on the market, and our experts agree that liquid-filled, two-piece, hard-shell capsules (LFCs) offer several advantages over other solid dosage forms, such as ease of scalability and manufacturing, faster absorption, simpler packaging, and excellent product stability.

    With LFCs, scientists can effectively formulate poorly soluble drugs, while reducing development time and costs.

    Watch our Executive Vice President of Operations, Ben Reed, explain in more detail.

    QUICK CHATS — The Benefits of Liquide-Filled Capsule Dosage Form

    Are liquid-filled capsules suitable for your API? Speak with an expert to find out.

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    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

    Your CDMO Partner, from Discovery to Commercialization 

     

    Whether for a single study or a full drug development program, Altasciences can support you. We offer contract manufacturing and analytical services, including formulation development, Phase I through commercial manufacturing, and ICH stability testing.

    Our integrated and synchronized approach to CRO and CDMO services, all under one organizational structure, can save you 25% to 40% in drug development time. 
     
    Watch our Executive Vice President of Operations, Ben Reed, discuss our expertise in more detail.

    QUICK CHATS — Why Partner with Altasciences for Drug Development & Manufacturing

    Questions? Speak with an expert!

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