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
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
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.