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.
Cancer Treatments, Clinical Trials, and the Motivation to Innovate
Getting to the Heart of Science with Michelle Newby
At the heart of science are stories—stories of courage, challenges, successes, lessons, and people. These stories motivate us in the pursuit of knowledge and breathe life into the work we do as researchers. They remind us of the immense benefits of drug development.
Don’t Delay Your Study Due to NHP Supply
Altasciences Ensures Nonhuman Primate Availability
Several preclinical CROs are expecting an impact on study start dates due to nonhuman primate (NHP) supply constraints. NOT Altasciences. We ensure NHP availability! We have the capacity at our four preclinical sites to start your studies six to eight weeks following contracting, thanks to our steady supply of NHPs.
SCHEDULE YOUR NHP STUDIES TODAY
At Altasciences, we remove the stress of sourcing research animals so that you can start your studies when you need to, with:
- Dedicated and diversified cynomolgus monkey supply agreements in place to allow for faster start-up timelines;
- A continuously maintained and backfilled population of hundreds of naïve NHPs at our preclinical facilities.
You can schedule newly contracted NHP studies to start immediately.
Have five minutes? Discover our extensive site capabilities:
- Webpage: Full Range of Preclinical Drug Development Solutions
- Fact Sheet: Preclinical Services Capabilities
- The Altascientist: Planning Your Preclinical Assessment
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.
Design and Validation of a Bioanalytical Method to Support a Clinical Pharmacokinetic Study Involving the Use of Multiple Lots of the Biological Therapeutic Drug
Top 10 Life Science Resources
There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below!
Top Nonclinical Scientific Resources
- The Altascientist Issue 32: A Changing Paradigm for Non-rodent Species in Nonclinical Safety Studies
Though historically used predominantly in dermal and wound healing research, an increasing body of evidence supports the use of miniature swine as a viable non-rodent option for your nonclinical safety studies. Discover the unique advantages of this large animal model alternative. Read or listen.
- Webinar: Gene and Cell Therapy: Enhanced CNS and Ocular Delivery in Nonhuman Primates
With the new modalities, early drug discovery may require more specialized and focused delivery options for animal disease models. Using recent case studies, Dr. Makori and Dr. Menodza share essential approaches and techniques to help you accurately administer drugs to an organ of interest. Watch it now.
Top Clinical Scientific Resources
The Altascientist Issue 31: The Advantages of Conducting Early Phase Clinical Research in Canada
Is conducting early phase clinical studies in Canada the right solution for you? There are several reasons why choosing Canada for your clinical trials can be beneficial. The FDA’s Investigational New Drug (IND) submissions can be put on hold for an undefined period during the application period and, as such, Canada’s clinical trial applications (CTA) can save you time and cut down costs.Read this issue of The Altascientist to discover the other ways your clinical trials could benefit. Read or listen.
- Ask an Altascientist: Q&A With Lisa Sanford on First-in-Human Trials
Do you need an IND before beginning a first-in-human trial within Canada? Altasciences’ expert Lisa Sanford is here to answer that question. Watch the Q&A.
Top Bioanalytical Resources
- Poster Presentation: Application of Mitra Microsampling for the Quantitative Bioanalysis of Antisense Oligonucleotides (ASOs)
Using research conducted at Altasciences, Dr. Chen discusses how the use of volumetric absorptive microsampling (VAMS) has recently emerged as an alternative to venous sampling, and provides insight into the first application of VAMS with the Neoteryx microsampling device. Watch the presentation.
- Podcast: Coupling Hybridization LC-MS Workflows With Microsampling for the Analysis of Antisense Oligonucleotides
Altasciences’ bioanalytical experts Dr. Chen and Jeff Plomley share with you their insights on workflows for the quantitative bioanalysis of antisense oligonucleotide (ASO) therapeutics. Find out how these breakthrough novel LC-MS-based strategies can be applied to your nonclinical studies. Listen here.
Top Manufacturing and Analytical Resources
- Ask an Altascientist: What Our Recent CDMO Facility Expansions Mean for You
Altasciences is constantly looking for ways to improve your drug development and manufacturing needs. In this video, Ben Reed, General Manager of CDMO services, explains how doubling the square footage of our CDMO campus has increased cGMP manufacturing bandwidth—and how your projects will benefit. Watch the video.
- Podcast: Tips to Ensure Successful Formulation for Nonclinical Safety Testing
Do you find yourself facing challenges during formulation development stages for nonclinical testing? In this podcast, our drug formulation and safety assessment experts share tips on how you can avoid and mitigate those challenges to facilitate your IND applications. Listen here.
Top CRO Research Support Services
- Video: Accelerate Your Data With our Co-located Clinic and Lab
Did you know that our Canadian clinical facility is only a 15-minute drive from our bioanalytical lab? Get a look into our workflow, and see how our operations are optimized to collect, process, and transport your samples for expedited go/no-go decision-making. Watch it now.
- Video: Inside Look at Ophthalmic Early Clinical Research with Dr. William Foster
At Altasciences, we have a fully integrated ophthalmology department, led by an experienced team of specialists. In this video, Dr. Foster explains how our state-of-the-art equipment and processes make us the perfect partner for your ophthalmic clinical trials. Watch it now.
Recent Regulatory Guidances and Updates
- FDA: Final Guidance Revision – Use of Whole Slide Imaging in Nonclinical Toxicology Studies
- FDA: Guidance Draft – Psychedelic Drugs: Considerations for Clinical Investigations
- FDA: Guidance Draft – E6(R3) Good Clinical Practice (GCP)
- FDA: Guidance Draft – Decentralized Clinical Trials for Drugs, Biological Products, and Devices
- FDA: Guidance Revision – Clinical Drug Interactions Studies With Combined Oral Contraceptives
Want to see more? Visit our Resource Center
Clinical Trials Arena: CRO Altasciences Works With Alzamend for Phase IIa Trial in Alzheimer's
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
An Overview of Health Canada's CTA Process
Watch this podcast in which Altasciences' regulatory experts share key insights on Health Canada's Clinical Trial Application (CTA) regulatory submission process, including answers to your most common questions.
Altasciences’ Canadian clinical facility consists of seven Phase I units. We conduct over 100 trials every year in Canada, and support the full range of first-in-human studies, specialty studies, and therapeutic areas, such as ophthalmology, CNS, and substance abuse.
Take five minutes to explore these insightful resources: