Brochure
29 Mar 2022
The Altascientist - Terminal Sterilization of Pharmaceutical Products
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Altasciences
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US
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2015On CPHI since
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3Certificates
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1000 - 4999Employees
Company types
Other Content from Altasciences (30)
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News Altasciences acquires Sinclair Research and continues to expand pre-clinical platform
Laval, Quebec, January 4, 2022 – Altasciences, an integrated CRO/CDMO offering pharmaceutical and biotechnology companies a seamless solution to early-stage drug development from lead candidate selection to clinical proof of concept, announced today the completed acquisition of Sinclair Research, a preclinical CRO located in the Midwest. Complementing existing locations on the East and West Coast, the new site will facilitate even greater access to Altasciences’ preclinical services across the U.S. -
Brochure Altasciences Manufacturing and Analytical Services
We provide proof of concept, R&D, clinical and commercial manufacturing, that includes liquid-filled capsules, band/sealing technologies, powder and over-encapsulated capsules, topical formulations, and clinical and blister packaging, manufactured in our purpose-built facility that includes state-of-the-art ISO 7 and ISO 8 cleanrooms. -
Brochure Altasciences Liquid-Filled Capsule
Getting your drug to the clinic - FAST -
Brochure The Altascientist - Maximizing Drug Formulation for First-in-Human Trials
Altasciences Scientific Journal -
Brochure Bioanalytical Services
From Discovery to Preclinical to Phase IV — Method Development, Validation, and Sample Analysis -
Brochure Clinical Solutions
Expertise in all clinical pharmacology studies required for regulatory submission across a wide range of therapeutic areas -
Brochure First in Human
Our experts in the design and conduct of first-in-human studies work closely with you to meet your objectives and milestones. We ensure participant safety with stringent risk mitigation plans, customized based on molecule target and available data. -
Brochure Integrated Drug Development Services
Integrated Drug Development Services -
Brochure Integrated Research Services
Integrated Research Services -
Brochure NDA-Enabling Studies
NDA-Enabling Studies -
Brochure Preclinical IND-enabling Insert Biologics
Preclinical IND-enabling Insert Biologics -
Brochure PHARMACEUTICAL CONTRACT MANUFACTURING SERVICES
PHARMACEUTICAL CONTRACT MANUFACTURING SERVICES -
Brochure Preclinical IND-enabling Insert Small Molecule
Small Molecule Safety Assessment -
Brochure Proactive Drug Development
Proactive Drug Development -
Brochure Special and Patient Populations
Special and Patient Populations -
Whitepaper Utilizing Nano Particulate Formulations In The Delivery Of Poorly Soluble Drugs
White Paper Nanomilling -
Whitepaper Applications of Liquid-Filled Capsules for Challenging APIs in Pharmaceutical Manufacturing
Whitepaper Liquid-Filled Capsules -
Video Altasciences' Pharmaceutical Manufacturing and Analytical Services at a Glance
Altasciences’ pharmaceutical contract development manufacturing organization (CDMO) has deep expertise and capabilities across a range of dosage forms.
All of our processes are supported by U.S.- and EU-compliant cGMP procedures, in conjunction with a robust, on-going training program. Our facility and equipment are designed, built, and fully qualified to meet and/or exceed all current regulations and guidance. We are agile, flexible, and always available. Analytical services include development and validation of methodologies, and a range of product-release testing.
Our GMP facility features an analytical lab, R&D formulations lab, multiple manufacturing suites, including segregated and dedicated potent handling capabilities, and a warehouse.
Our pharmaceutical contract manufacturing expertise includes liquid and powder-filled capsules, nanomilled suspensions, creams, gels, powders, and terminally sterilized injectables, which are manufactured in our purpose-built facility with state-of-the-art Grade C cleanrooms. We handle APIs/HPAPIs from formulation through commercial scale and offer analytical method development, qualification, and validation for the in-process and finished product, as well as ICH stability storage.
Altasciences is an integrated drug development solution company, offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to their preclinical and clinical study needs. From lead candidate selection to proof of concept, we offer one-stop integrated formulation, preclinical and clinical manufacturing and analytical services. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements.
Altasciences… helping sponsors get better drugs to the people who need them, faster.
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Video Altasciences — Manufacturing and Analytical Services
At Altasciences, our experts in pharmaceutical contract manufacturing are ready to support you in formulation, validation, commercial batches, and controlled substances. We have tested or manufactured almost all available dosage forms on the market, including liquid- and powder-filled capsules, nanomilled suspensions, creams, gels, tablets, and terminally sterilized injectables. Analytical services include development and validation of methodologies, and a range of product-release testing.
Altasciences is an integrated drug development solution company, offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to their preclinical and clinical study needs. From lead candidate selection to proof of concept, we offer one-stop integrated formulation, preclinical and clinical manufacturing and analytical services. Our full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements.
We help sponsors get better drugs to the people who need them, faster.
Learn more about our manufacturing and analytical solutions: https://www.altasciences.com/manufacturing-and-analytical-services
To discover our full range of integrated solutions, visit: https://www.altasciences.com
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Video Step Inside Altasciences' Manufacturing and Analytical Services Facility
A sneak peek at what awaits you inside our manufacturing analytical services facility in Philadelphia.
Located in Philadelphia, Altasciences' 64,000-square-foot CDMO facility is built to help you with proof of concept, R&D, and clinical and commercial manufacturing. Our state-of-the-art facility features:
• 9,500-sq.-ft. warehouse
• 3,300-sq.-ft. manufacturing area
• 2,500-sq.-ft. segregated ISO7/8 manufacturing area
• 1,500-sq.-ft. R&D formulations lab
• 3,000-sq.-ft. analytical lab
• ISO 7 and ISO 8 cleanrooms
• cGMP client-dedicated manufacturing suites
• 8,750-sq.-ft. warehouse
We have tested or manufactured almost all available dosage forms on the market, including liquid- and powder-filled capsules, nanomilled suspensions, creams, gels, tablets, and terminally sterilized injectables. Analytical services include development and validation of methodologies.
Altasciences is an integrated drug development solution company, offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to their preclinical and clinical study needs. From lead candidate selection to proof of concept, we offer one-stop integrated formulation, preclinical and clinical manufacturing and analytical services. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements.
Altasciences… helping sponsors get better drugs to the people who need them, faster.
Discover our manufacturing and analytical services.
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Video Impossible is Not an Option | Altasciences
Drug development is about transforming the impossible into possibilities, the possibilities into reality. And when we partner together to build a healthier world, anything is possible.
Altasciences is an integrated drug development solution company, offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to their preclinical and clinical study needs. From lead candidate selection to proof of concept, we offer one-stop integrated formulation, preclinical and clinical manufacturing and analytical services. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements.
Altasciences… helping sponsors get better drugs to the people who need them, faster. Visit our website to learn more: https://www.altasciences.com/
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Video Partnering Together for Early Phase Drug Development | Altasciences
Together, anything is possible.
Altasciences is an integrated drug development solution company, offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to their preclinical and clinical study needs. From lead candidate selection to proof of concept, we offer one-stop integrated formulation, preclinical and clinical manufacturing and analytical services. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements.
Altasciences… helping sponsors get better drugs to the people who need them, faster. Visit our website to learn more: https://www.altasciences.com/
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Video Just Imagine... Easier, Proactive Drug Development
Imagine the possibilities of partnering with a single CRO/CDMO partner for your early phase drug development... With Altasciences, you don't have to imagine — we deliver.
Altasciences is an integrated drug development solution company, offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to their preclinical and clinical study needs. From lead candidate selection to proof of concept, we offer one-stop integrated formulation, preclinical and clinical manufacturing and analytical services. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements.
Altasciences… helping sponsors get better drugs to the people who need them, faster. Visit our website to learn more: https://www.altasciences.com/
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Video A.T.L.A.S. — Your Custom Roadmap to Drug Development with Altasciences
A.T.L.A.S. from Altasciences makes outsourcing the early phases of drug development easier and faster for you.
A custom plan for your unique drug development process, A.T.L.A.S. streamlines your project’s moving parts across all phases, across all of our sites, by using a centralized scheduling system and a proprietary communication tool to actively track and manage your study information, results, timelines, clinical sites, study personnel, and milestones. Each department works in unison towards your goals, seamlessly transitioning your molecule from one phase to the next, from lead candidate selection to clinical proof of concept, and beyond.
We start building your drug development plan at the proposal stage. From there, your dedicated, cross-functional project manager and interdisciplinary work with you to design a personalized roadmap for your unique situation. Structured around your milestones, we coordinate the phases of your project, accelerate decision-making, and optimize R&D timelines with parallel processing to save you up to 40% in time.
Altasciences is an award-winning, integrated drug development solution company, offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to their preclinical and clinical study needs. From lead candidate selection to proof of concept, we offer one-stop integrated formulation, preclinical and clinical manufacturing and analytical services. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements. Altasciences… helping sponsors get better drugs to the people who need them, faster. Visit our website to learn more: https://www.altasciences.com/
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