Manufacturing and Analytical Services
Case Study―Evaluating Milling Conditions for Scaling Up a Nanosuspension Drug Product
Mastering the Art of Formulation
Your Formulations, Brewed to Perfection.
Pharmaceutical formulation is one of the most critical steps in early phase drug development. The successful formulation of your active pharmaceutical ingredient (API) will ensure a smooth transition to preclinical testing and clinical trials, and eventually to market.
Our experts have vast experience formulating both simple and complex formulations, using techniques such as nanomilling to successfully formulate even the most challenging, insoluble, or highly potent APIs―ensuring you have your preclinical and clinical study material on time.
Here's a glimpse of our scientists working their magic!
Do you have an API that needs to be formulated? Contact us to get started.
Related Resources:
Ophthalmic End-to-End Drug Development Solutions
Tackling Formulation and Early Development Challenges of CNS Drugs
Avoid Roadblocks in CNS Drug Development
Development of drugs to treat central nervous system (CNS) disorders presents a unique set of challenges, including active pharmaceutical ingredients (APIs) with low solubility, poor bioavailability, or highly potent characteristics.
Altasciences is equipped to handle the formulation, as well as the preclinical, clinical, and commercial development of CNS drugs. Our FDA-registered and inspected cGMP manufacturing and analytical facilities are equipped with:
- DEA manufacturing and analytical license for drug Schedules I to V
- Segregated Grade C and D cleanrooms for the handling of highly potent APIs
- In-house R&D and formulation laboratories for drug product release and ICH stability testing
- Method development for low concentration formulations often used for psychedelics
- cGMP warehouse, including narcotic vaults and cold storage
Our scientific team has expertise with liquid-filled capsules, often the preferred dosage form for CNS drugs. We are also highly skilled in complex formulations and testing of controlled substances, including cannabidiols.
Get in touch to discuss how we can rapidly formulate and advance your CNS drug product to market.
Related Resources
- Webpage: Full Range of Manufacturing and Analytical Solutions
- Video: Handling of Highly Potent APIs and Controlled Substances
- Webpage: An Integrated Solution for Your First-In-Human 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.
This is Where the Magic Happens
Discover Our R&D and Formulation Laboratories and Services
Analytical testing plays a pivotal role in all phases of pharmaceutical development. No matter how complex your molecule is, our scientists formulate it and use robust analytical instrumentation and processes to ensure the quality of your in-process or finished drug product, and rapidly advance it to the next phase of development.
Our analytical services include:
- Method development, qualification, and validation
- Drug product release testing
- On-site ICH stability storage and testing
- Controlled substance testing (DEA manufacturing and analytical license, Schedules I-V)
- Excipients and active pharmaceutical ingredients (APIs)
- Packaging components
Take a virtual tour of our R&D and formulation laboratories to see where the magic happens!
Want to benefit from our services? Book a consult today.
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.
Optimizing Drug Formulations for Successful First-in-Human Clinical Trials
Ensure a Smooth Transition from Formulation to Clinical Trials
Altasciences supports your formulation and drug development needs for preclinical safety testing, from discovery through first-in-human (FIH) clinical trials, for all dosage forms, such as oral liquids, powders, capsules, and injectables.
Our integrated approach combines formulation development, cGMP manufacturing and release testing, as well as clinical testing functions/workflows. One of the biggest benefits of this seamless offering is that our clinical trial teams work closely with the scientists involved in the formulation and manufacturing process, and are able to evaluate and optimize new formulations in the clinic, based on real-time human data. This collaboration and data sharing between our teams leads to shorter timelines, less risk, reduced costs, and improved flexibility.
Learn more about our expertise with both simple and complex formulation development, including those with highly potent APIs and solubility/bioavailability challenges.
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Questions? Speak with one of our experts.
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 Real Reason Why Sponsors Choose Liquid-Filled Capsules Over Tablets in Drug Development
Applications Of Liquid-Filled Hard‑Shell Capsules In Drug Development
Often selected for drugs with poor solubility/bioavailability, liquid-filled hard-shell capsules (LFHCs) have various applications and specific benefits over other solid oral dosage forms in different phases of pharmaceutical development.
In this issue of The Altascientist, you will find:
- Applications of LFHCs
- Advantages of LFHCs over other solid oral dosage forms
- The process for developing an LFHC formulation
- The role of excipients
- CASE STUDY: The Rapid Development of an LFHC Formulation of Cannabidiol
Contact us to optimize your drug development by using liquid-filled capsules.
Got a few more minutes? Check these out.
- Infographic: Top 5 benefits of liquid-filled capsules over tablets
- Quick Chat: Advantages of using liquid-filled capsules as a dosage form 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.
Six Reasons to Choose Altasciences as Your CDMO Partner
Whether you are embarking on Preclinical safety testing, Phase I clinical trials, or need manufacturing services f
Still Using Tablets in Your Clinical Trials? Consider Changing to a Better Option.
Accelerate Your Clinical Trials With This Dosage Form
With tablets presenting numerous drawbacks, liquid-filled capsules (LFCs) are becoming the optimal choice for clinical trials. Their benefits include:
- Ease of scalability from preclinical to clinical to commercial volumes
- Quick dose adjustments
- Faster dissolution and absorption
- Less required stability studies
LFCs are most suitable for drugs with complex formulations, low-dose requirements, poor solubility, or highly potent active pharmaceutical ingredients (APIs). Clients with such drug profiles substantially accelerated their drug development process using LFCs for early phase clinical trials, resulting in reduced costs.
Where Do We Come In?
Altasciences’ state-of-the-art cGMP manufacturing and analytical facility in Philadelphia has a team of experienced scientists to support you through your entire drug development process, from pre-formulation to clinical trials and beyond. Our advanced equipment includes cutting-edge liquid-filling, binding, and sealing machines, ensuring an impressive 97% right-first-time (RFT) batch release success rate.
Consult our resources for further details on how you can benefit from using LFCs in your clinical trials.
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Ready to accelerate your drug development? Speak with one of our experts.
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.