Manufacturing and Analytical Services
How We Formulate Complex APIs Others Can’t
How We Succeed When Others Can’t
Andrew Buis, Senior Formulation Scientist at Altasciences, explains how we succeed in developing the most complex formulations when others fail, and even customize them based on specific client needs.
Points of discussion include:
- Our facility design, equipment, and experience
- What our recent 35,000-sq.-ft. expansion means for clients
- How we develop customized formulations
- How we formulated APIs for clients when others failed
Got 5 more minutes? Check out:
- Video: Manufacturing and Handling Highly Potent APIs and Controlled Substances
- Webpage: Altasciences’ Drug Development, Manufacturing, and Analytical Solutions
- Scientific Paper: Benefits of Liquid-Filled Capsules Versus Tablets in Pharmaceutical Development
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.
Test Your Knowledge of Liquid-Filled Capsules
Thanks to updated screening methods and bioavailability enhancements, poorly soluble molecules comprise 70% to 80% of the small molecule products entering the drug development pipeline today. Since poorly soluble drugs are difficult to formulate as tablets, formulation scientists are looking to two-piece, liquid-filled hard-shell capsules as a solution.
FDA Says Use Terminal Sterilization Over Aseptic Manufacturing. Find Out Why.
Terminal sterilization is the most effective way to reduce the chances of microbial contamination and provides a higher level of sterility assurance to finished drug products. It is also less complex, less costly, and more easily reproducible than aseptic manufacturing.
Discover the full range of benefits by viewing the webinar on-demand.
Topics include:
- Differences between aseptic processing and terminal sterilization
- Common misconceptions about terminal sterilization
- Preferences and expectations of regulatory agencies
- How to evaluate your product’s compatibility
Case study also included!
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.
Things You Never Knew ― Benefits of Working With a Drug Development Consultant
The importance of working with a drug development and manufacturing consultant
In this podcast with Dr. Daniel E. Levy, we uncover the key considerations when putting together your drug development and manufacturing program, the importance of securing a drug development and manufacturing expert, and the most important things to look for in an integrated CRO/CDMO partner.
Listen to the podcast!
You may also be interested in the following:
WEBINAR ― Join Altasciences and Prince Terminal Sterilization for a complimentary webinar to find out why the FDA and EMA recommend terminal sterilization over aseptic manufacturing, and its many advantages for your drug 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. Our experts in pharmaceutical contract manufacturing and analytical testing are ready to support you for formulation, method development and validation, clinical trial supply, and commercial batch manufacturing. We have tested or manufactured almost all available dosage forms on the market, including liquid- and powder-filled capsules, nano-milled suspensions, creams, gels, and terminally sterilized injectables.
CASE STUDY ― The Rapid Development of CBD Formulations From Scratch for a New OTC Product
Altasciences has become the go-to partner for pharmaceutical companies striving to develop safe and effective cannabidiol (CBD) products to address unmet medical needs. With our integrated early phase drug development solutions, we can quickly undertake formulation development and clinical manufacturing of next generation formulations with challenging APIs and controlled substances, such as CBD.
In this latest case study, our client (Emyria) presented the challenge of developing several oral formulation candidates for CBD from scratch for a new over-the-counter (OTC) product. Learn how we completed the entire project in just over three months!
You may also be interested in:
- Web page: Our Full Range of Manufacturing and Analytical Solutions
- Podcast: High Potency Manufacturing Solutions
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.
Rapid Development of a Liquid-filled, Hard-Shell Capsule Formulation of Cannabidiol
The Importance of Customized Analytical Solutions for Your Molecules
Analytical Testing in Pharmaceutical Development
Analytical testing plays a pivotal role in all phases of pharmaceutical development and is one of the most outsourced services among drug developers today.
At Altasciences, we use the latest instrumentation to support your drug development and manufacturing, no matter how complex or challenging your molecule is. Our robust analytical procedures ensure the quality of your raw, in-process, or finished product, and provide method development and validation to meet the ever-evolving requirements of regulatory agencies worldwide.
We provide you with:
- Method development, qualification, and validation
- On-site ICH stability testing and storage
- Controlled substance testing
- Excipient and active pharmaceutical ingredients (APIs)
- Drug product release and stability testing
Discover our full array of analytical solutions, or speak with one of our experts to get started.
You may also be interested in:
- A virtual tour of our analytical laboratories
- Our full range of manufacturing and analytical solutions
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.
The Value in Working With a Consultant in Your Drug Development Journey
The importance of working with a drug development and manufacturing consultant
In this podcast with Dr. Daniel E. Levy, we uncover the key considerations when putting together your drug development and manufacturing program, the importance of securing a drug development and manufacturing expert, and the most important things to look for in an integrated CRO/CDMO partner.
Listen to the podcast!
You may also be interested in the following:
WEBINAR ― Join Altasciences and Prince Terminal Sterilization for a complimentary webinar to find out why the FDA and EMA recommend terminal sterilization over aseptic manufacturing, and its many advantages for your drug 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. Our experts in pharmaceutical contract manufacturing and analytical testing are ready to support you for formulation, method development and validation, clinical trial supply, and commercial batch manufacturing. We have tested or manufactured almost all available dosage forms on the market, including liquid- and powder-filled capsules, nano-milled suspensions, creams, gels, and terminally sterilized injectables.
The Advantages of Liquid-Filled Capsules Over Tablets in All Phases of Drug Development
Getting a Handle on Highly Potent APIs and Controlled Substances
Manufacturing and Handling Highly Potent APIs and Controlled Substances
With more highly potent APIs (HPAPIs) coming through the R&D pipeline than ever before, it has become increasingly important to partner with the right CDMO to rapidly formulate and manufacture your HPAPIs for preclinical, clinical, and commercial development.
In this Quick Chat video with Ben Reed, learn how Altasciences, a fully integrated CRO/CDMO, handles the most challenging drug substances, from early phase development to commercialization, including:
- Industry-leading technologies used for formulation, containment, and sterilization
- Seamless shipping and handling of your HPAPIs and controlled substances
- Safety procedures and protocols
Have questions? Speak with our experts.
You may also be interested in the following:
- Webpage: Pharmaceutical Contract Manufacturing and Analytical Services
- Webinar: The Development of Nanosuspension Formulations for Poorly Soluble Drugs
- E-Book: The Benefits of Liquid-Filled Capsules in Pharmaceutical Development
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.