Are You Looking for Help with Scientific Publications?
Scientific Publication Writing — Let Us Help!
Altasciences’ scientific experts can provide you with strategic guidance and quality writing for your next scientific publication. Our solution includes writing for a wide range of therapeutic areas, for your preclinical to clinical research — as part of a full‑service program completed at our facilities or as a stand-alone offering.
Benefit from:
- Strategic publication guidance and content development for manuscripts, posters, and abstracts
- Expert review and editing of your pre-written publications
- And more!
Have 5 minutes? You may be interested in:
- Comprehensive Research Support Capabilities
- Scientific, Regulatory, and Strategic Guidance
- Full-Time Equivalent Capabilities
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.
FDA and EMA Prefer Terminal Sterilization Over Aseptic Manufacturing ― Find Out Why
Advantages of Terminal Sterilization Over Aseptic Manufacturing
Regulatory agencies such as the FDA and EMA generally prefer terminal sterilization over aseptic manufacturing, as it provides a high level of sterility assurance. It is also less complex, less costly, more easily reproducible than aseptic manufacturing, and offers time savings to pharmaceutical companies.
In this issue of The Altascientist, we discuss:
- Differences between terminal sterilization and aseptic manufacturing
- Sterilization methods for pharmaceutical products
- Validation steps during sterilization
- Method selection
Read to learn how terminal sterilization can benefit your drug product.
Questions? Speak with one of our experts? Contact Us.
Proactive Investors: Emyria's Ultra-Pure CBD Capsule Outperforms TGA-Approved CBD Treatment in Pre-Clinical Animal Trial
Drug Discovery World: Pharmacokinetic Study for Developing Kidney Disease and Injury Therapies
Altasciences Chosen by Respira Technologies, Inc. as Drug Product Manufacturing Partner for the World’s First Inhaled Nicotine Replacement Therapy (NRT)
Laval, Quebec, December 14, 2021 – Altasciences’ pharmaceutical contract manufacturing site in Philadelphia, PA, has been chosen by Respira Technologies, Inc. to manufacture proprietary drug products for the world’s first inhaled smoking cessation therapy. This treatment uses RespiRx™, a vibrating mesh nebulizer (VMN) with a maintenance-free disposable cartridge that reduces and potentially eliminates the risk of patient misuse and non-compliance.
Following a successful Pre-Investigational New Drug (IND) meeting with the Food and Drug Administration (FDA) on November 18, Respira is intending to submit their IND application in 2022 under the 505(b)(2) regulatory pathway.
Respira also plans to create a larger platform approach for active pharmaceutical ingredient (API) delivery, taking advantage of the multi-drug capabilities of their proprietary platform drug delivery system. To date, 91 potential APIs have been identified.
“Our team chooses best-in-class partners, and working with Altasciences has been a great experience overall. Altasciences is playing a big role in advancing Respira’s ambition to secure the FDA’s authorization on a potential breakthrough drug product, and through this collaborative environment, we can change the world of drug development. Altasciences is agile, flexible, and quick, while providing the proven expertise and capability required for cGMP pharma drug product manufacturing. We are thankful for their fast response rate, creativity, and ability to take on the needs of nimble start-ups like Respira,” said Mario Danek, Founder and CEO at Respira Technologies, Inc.
Altasciences leverages deep expertise in formulation, development, and manufacturing, as well as flexible processes and significant investments in state-of-the-art technologies, to support clients in their research and commercial manufacturing requirements.
“We are delighted to be partnering with Respira Technologies, Inc. on this new and exciting technology. Our team has truly enjoyed having the opportunity to work with a world-class organization that quickly makes key decisions to ensure we meet accelerated timelines,” stated Ben Reed, Executive Vice President of Operations at Altasciences.
More information on Respira Technologies, Inc.’s program can be found here.
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization 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.
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
Four Reasons to Choose Altasciences as Your Flow Cytometry Partner
Altasciences offers specialized services in flow cytometry, a highly sensitive system
Start Your Clinical Trials Sooner
Our clinical trial experts set your drug development program up for success by proactively preparing and performing each critical moving part while others are underway. As a single source for early phase drug development solutions, we integrate and synchronize key CRO/CDMO activities, such as clinic-ready manufacturing, bioanalysis, clinical study conduct, and regulatory review, so that you’re always ready for the next step.
Check out how we do this and experience the difference.
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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.