High Potency Drug Manufacturing Solutions for Your Program
Altasciences’ CDMO facility is equipped to manufacture and handle highly potent compounds.
- Scalable, segregated, flexible, GMP high potency/Grade C and D clean rooms with dedicated air handling for potent compounds
- State-of-the-art equipment for safe, effective manufacture of your potent materials, from clinical through commercialization
- Formulation and product development
- Multiple dose capabilities
Listen to the podcast to learn more on how Altasciences handles and manufactures highly potent pharmaceutical ingredients, the equipment used, and the rigorous processes in place to ensure your program's success, safely.
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| Ben Reed Executive Vice President, Operations Altasciences breed@altasciences.com |
Shawn J. Connaghan Vice President, Quality Assurance Altasciences sconnaghan@altasciences.com |
Do you have questions? Speak with an expert.
You may also be interested in the following:
- Webpage: Overview of our Pharmaceutical Contract Manufacturing Services
- Video: Altasciences’ Manufacturing & Analytical Solutions
- Video: Benefits of Liquid-Filled Capsule Manufacturing
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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 Brain on Drugs ― a Discussion with Neuroscientist Dr. Denise Milovan
This on-demand webinar focuses on the importance of including biologic and cognitive pharmacodynamic markers in your early phase clinical trials.
Presenters Dr. Beatrice Setnik and Dr. Denise Milovan unpack:
- Strategic information collected through targeted cognitive markers
- How cognitive endpoints guide the design of clinical trials
- Specialty studies to help make informed clinical development decisions
- Why include biomarkers in early phase trials, including neurology and inflammation
To learn more about our CNS-driven solutions, speak with our experts.
You may also be interested in the following:
- Webinar: The Many Facets of Early Phase Evaluation of Psychedelics in Psychiatry
- The Altascientist: Maximizing Drug Formulation for First-in-Human Trials
- Webpage: Human Abuse Potential Capabilities
- Fact Sheet: Bioanalytical Services
- Video: Altasciences ― Fully Integrated Drug Development Solutions
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
Take a Virtual Tour of our State‑of‑the‑Art Bioanalytical Laboratories
From Discovery to Preclinical to Phase IV, Altasciences’ Laboratory Sciences team of over 260 scientific experts specialized in bioanalysis, ligand binding assays (LBA), mass spectrometry, immunology, biomarkers, and PCR, operates in three strategic locations in proximity to our preclinical and clinical sites. We aim to provide top quality data for TK, PK, and PD determinations to support your preclinical and clinical studies.
Our LC-MS/MS and LBA laboratories feature:
- Capacity to analyze over 60,000 study samples per month
- Designated containment level 2 areas for risk group 2 pathogens
- State-of-the-art instrumentation
- SCC GLP accreditation
- On-site 24/7 security
Catch a glimpse of the facility here.
Request a full virtual tour of our bioanalytical laboratories or contact us for more information.
You may also be interested in the following:
- Webpages:
- Podcast: Three Laboratories ― One Vision, with Dr. Lynne Le Sauteur
- The Altascientist: Microsampling ― Applications, Benefits and Considerations
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
Have you Considered Microsampling for your ANDA Submission?
Have you seen the recent FDA guidance confirming the possibility of using microsampling for PK sampling in ANDA trials? Please refer to Section 3c, page 11 of the guidance entitled Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.
Altasciences’ leadership and expertise in the field of microsampling is unparalleled, including preclinical collection, clinical collection and self-sampling, and bioanalytical method development using a variety of microsampling techniques and devices.
You may also be interested in the following:
- The Altascientist Scientific Journal: Microsampling
- Fact Sheet: Microsampling in Early Phase Drug Development
- Blog: Leveraging the Benefits of Microsampling for Safety and Convenience
- Video (two minutes): Microsampling
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.
Options and Opportunities for Safety Pharmacology Studies
Help guide the safe performance of clinical trials through design and conduct using thorough data from safety pharmacology studies.
Read The Altascientist Issue 13 – Safety Pharmacology Guidelines and Practices
Efficiencies in time and resources, as well as certain analytical advantages, can be realized by:
- combining safety pharmacology studies (i.e., cardiovascular and respiratory) where appropriate
- including safety pharmacology endpoints in general toxicity studies
You may also be interested in the following:
- Brochure: Safety Pharmacology Capabilities
- Podcast: Altasciences’ Scientific Experts Discuss Safety Pharmacology (10 mins.)
- ICH Guidance for Industry S7A Safety Pharmacology Studies for Human Pharmaceuticals
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.
Take a Virtual Tour of our State‑of‑the‑Art Clinical Laboratories
With over 25 years’ experience in clinical pharmacology, our experts provide comprehensive drug development solutions to get your molecule to clinical proof of concept. Our experienced team can guide you in the design and conduct of your studies in a wide range of therapeutic areas, including small molecules, biologics, 505(b)(2) and hybrid applications.
Combined, our clinical pharmacology units total 130,000 square feet and feature:
- Over 500 beds
- 10 on-site driving simulators
- On-site pharmacies
- Long-term stay facilities
- Upscale amenities for participants
- Outpatient and return units
- Participant screening facilities
- 24/7 security
Catch a glimpse of the facility here.
Request a full virtual tour of our clinical facilities or contact us for more information.
You may also be interested in the following:
- Webpages:
- Webinar: The Strategic Use of Cognitive Measures and Biomarkers in Early-Phase CNS Drug Studies
- The Altascientist: Central Nervous System Active Drugs ― Complex Considerations
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
Altasciences Named Best Mid-Size Early Phase CRO (North America) and Leading Providers of Preclinical Safety Testing Services by GHP News at the 2021 Biotechnology Awards
Don’t Miss it ― a Regulatory Discussion with our Experts
Complimentary Webinar — Clinical Trials in Support of a U.S. Drug Submission
Did you know that first-in-human (FIH) clinical trials conducted in Canada can accelerate regulatory approvals from the EMA and the U.S. FDA?
For an overview of foreign health authority requirements for approval to conduct a FIH clinical trial, including a comparison of Health Canada’s and the EMA’s Clinical Trial Authorization (CTA) processes and the U.S. FDA’s Investigational New Drug (IND) submission process, watch this complimentary webinar.
Topics covered include:
- Ensuring timely FIH clinical trials when planning your early phase drug development strategy
- Utilizing foreign clinical trials for U.S. FDA drug submissions and approvals
- Differences in the quality and nonclinical data submission requirements to gain EMA, FDA, and Health Canada approval to conduct FIH trials
Contact us to discuss the additional benefits of conducting FIH trials in Canada.
You may also be interested in the following:
- Webpage: Scientific, Regulatory, and Strategic Guidance
- Fact sheet: Clinical Sample Collection Kits
- Fact sheet: First-in-Human (FIH) Studies
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.
Take a Virtual Tour of our State‑of‑the‑Art Preclinical Facility
With over 25 years’ experience conducting safety assessment, Altasciences’ preclinical facility in Seattle offers a wide array of solutions, including IND/CTA and NDA-enabling safety assessment, as well as laboratory services for both small and large molecules.
In this 210,000-square-foot, purpose-built facility, Altasciences can thoroughly assess the safety of your molecules with a full range of in vivo GLP and non-GLP preclinical evaluation studies in both rodent and non-rodent species. We’ve conducted over 2,400 safety studies at this site, which features:
- 140 custom-design animal rooms, including European housing
- 4,500 sq.-ft. archive facility
- Capacity to house ~3,000 NHPs, ~500 Canines, ~100 Swine, ~12,000 Rodents, ~800 Rabbits
- AAALAC accreditation
- USDA registration
- OLAW assurance
- BSL-2 certification
Catch a glimpse of the facility here.
Request a full virtual tour of our Seattle site or contact us for more information on our newest preclinical site in Scranton.
You may also be interested in the following:
- Webpage: Preclinical Drug Development Solutions
- Podcast: Science, 3Rs, and Animal Welfare with Dr. Megan R. LaFollette from 3RNA
- Webinar: Comparison of the U.S. FDA and Health Canada CTA submission Process to Support First-in-Human Phase I Studies
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.