Manufacturing and Analytical Services
Insights for Optimizing Your Preclinical Formulation and Drug Product Manufacture
Setting the Stage for Success
In this issue of The Altascientist, we explore critical considerations for formulation development and manufacturing for preclinical testing.
You'll discover strategies employed by our experts to support your projects, as well as a case study.
Topics covered include:
• e-formulation studies
• biopharmaceutical assessments
• steps in preclinical drug product manufacturing
• quality control procedures
• regulatory aspects
• risk management
Ready to discuss your pharmaceutical formulation and manufacturing needs? Send us a message.
Related resources that may interest you:
• Webpage: Comprehensive Drug Development, Manufacturing, and Analytical Testing Services
• Podcast: Key Considerations When Formulating APIs for Preclinical Testing
• eBook: Maximizing Formulations for First-in-Human Trials
Expert Drug Development Tips for Optimal Outcomes―From Start to Finish
Achieve Your Milestones
Altasciences' in-house experts support your drug development and manufacturing needs from API formulation to preclinical and clinical material supply, to market.
Tune in to our podcast, where we explore the challenges pharmaceutical developers face due to manufacturing issues and reveal critical considerations to avoid potential roadblocks.
Listen now!
Tell us how we can help with your drug development journey ― contact us today
Related resources that may interest you:
• Webpage: Altasciences’ Integrated Drug Development, Manufacturing, and Analytical Services
• Infographic: Choosing the Optimal Dosage Form for Your Clinical Trials
• Podcast: Key Considerations When Formulating APIs for Preclinical Testing
Inside the Altascientist: Considerations for Safe and Compliant HPAPI Manufacturing
In recent years, advancements in oncological research have fueled a surge in demand for highly potent active pharmaceutical ingredients (HPAPIs). So much so that the HPAPI market is estimated to reach USD 31.5 billion by 2029.
Thousands of HPAPIs are currently in development that promise lower dose requirements, enhanced efficacy, improved patient compliance, and fewer side effects.
Achieve Enhanced API Formulation Development Using This Technique
Insoluble APIs, Meet Your Match!
Poorly soluble active pharmaceutical ingredients (APIs) made from hydrophobic, amorphous-solid, or crystalline-type materials are highly manageable when you opt for nanomilling ― a complex and game-changing process that pulverizes and stabilizes particles.
Hear more on the topic from Andrew Buis, Senior Formulation Scientist at Altasciences, in this short video.
If you have any questions about nanomilling or need help formulating your APIs, speak with one of our experts today.
You may also be interested in:
• Webpage: Drug Manufacturing and Analytical Testing Services
• Scientific Journal: Achieving Better Solubility and Bioavailability
• Webinar: Development of Nanosuspension Formulations for Poorly Soluble Drugs
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, 2023 – Altasciences is pleased to welcome Angel
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