Manufacturing and Analytical Services
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.
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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
Embarking on a Career in Drug Development
Getting to the Heart of Science with Amber malloy
ISSUE NO. 35 — Critical Considerations for the Safe and Compliant Manufacture of Highly Potent Drugs
Cost-Effective Sterilization Method
Regulatory agencies, including the FDA and EMA, prefer terminal sterilization over aseptic manufacturing, as it is less complex, less costly, and easily reproducible―providing a higher level of sterility assurance and patient safety. Sterilization also takes place after formulation, once the product has been filled into the primary packaging, making it the optimal choice.
Learn more about our expertise and find out if terminal sterilization is suitable for your product.
Questions? Speak with one of our experts.
Related resources that may interest you:
Webinar: Advantages of Terminal Sterilization Over Aseptic Manufacturing
Scientific Journal: Terminal Sterilization of Pharmaceutical products
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.
You have questions; we have answers.
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VIRTUAL TOUR: Discover our In-House R&D and Formulation Laboratories
Enhance Your Outcomes With Our Analytical Services
Altasciences’ in-house R&D and formulation laboratories offer an extensive array of analytical solutions to support sponsors’ drug development and manufacturing programs.
Our services include:
• HPLC/UPLC testing
• Method development and validation
• ICH stability storage and testing
• APIs, excipients, and packaging components
• Drug product release testing, including controlled substances
Take a virtual tour of our laboratories, or consult with one of our experts to discuss your study needs.
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.
Insights―Successful Manufacturing of Clinical Trial Supply
Discover the Secrets to Clinical Trial Success
As an integrated CRO/CDMO, Altasciences’ Clinical and CDMO teams work in tandem to manufacture the optimal dosage in preparation for first-in-human clinical trials.
In this latest podcast, our formulation and pharmacy experts share their secrets for successfully completing clinical trials and resolving issues that could impact your drug development program’s timeline.
Speak with our experts for all your pharmaceutical development and manufacturing needs in support of your upcoming clinical trials.
Related resources that may interest you:
• Webpage: Altasciences’ Manufacturing and Analytical Services
• Scientific Journal: Maximizing Formulations for First-in-Human Trials
• Infographic: Benefits of Using Liquid-Filled Capsules in Clinical Trials
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.
Custom Dosage Form Solutions for All Study Phases
Versatile Dosage Forms―From Formulation to Market
For decades now, our U.S.-based cGMP manufacturing and analytical testing facility has been moving molecules from benchtop to market. Following formulation, we manufacture the dosage form you require for your nonclinical and clinical studies, as well as your commercial batches.
Dosage forms we manufacture and package include tablets, liquid-filled hard-shell capsules, powder-filled capsules, over-encapsulation, injectables, liquids and suspensions, creams, and gels.
Consult with our experts to discover how we can fulfill your manufacturing needs.
Resources that may interest you:
• Infographic: Benefits of Liquid-Filled Capsules as a Dosage Form
• Quick Chat: What Our Facility Expansions Mean For You
• Webpage: Altasciences’ Comprehensive Drug Manufacturing and Analytical Testing Services