Manufacturing and Analytical Services
Seamless Bioanalytical Transition from Preclinical to Clinical, and Beyond
Seamless Bioanalytical Transition
Altasciences’ scientists move in unison with you, collaboratively, accurately, and efficiently, from preclinical to clinical, and beyond. Our team of over 260 bioanalytical scientific veterans is strategically located across North America, and has experience with a wide spectrum of biological matrices in both animal and humans.
Driven by your assay requirements, our program support includes LC-MS/MS, LBA OR HYBRID LBA/LC-MS/MS ASSAY platforms for:
|
|
Have 5 minutes? You may also be interested in the following:
- Assay List — Over 685 Assays covering 650 Molecules
- The Altascientist — Validation of Immunogenicity Assays
- Webinar — Development of a Cell-Based Assay for Dual Purposes: to Support Drug Potency and Immunogenicity Characterization
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.
How Novel Data-Driven Treatments Are Improving Patient Care
PODCAST — How Novel Data-Driven Treatments Are Improving Patient Care
Special guest Dr. Michael Winlo, Managing Director at Emyria, joins us for a very insightful conversation about their unique programs and new patient care models. Emyria is a biotech company that brings together patients, clinicians, researchers, and medical innovators to develop data-driven, novel treatments for patients in need, including cannibidiol formulations.
Have 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.
One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs
Overcoming Challenges in the Formulation and Development of Controlled Substances
Partnering for the Development of Psychedelics, Cannabidiol (CBD), and Other Scheduled Drugs
Altasciences can help develop and commercialize first- and second-generation novel therapeutics for the treatment of mental health, addiction, and CNS disorders. We are a recognized CNS center of excellence, specializing in the formulation, development, analysis, testing, and manufacturing of controlled substances for clinical trial supply all the way through to commercialization.
When partnering with us, you benefit from our state-of-the-art facilities and advanced expertise, including:
- DEA license for drug Schedules I-V for manufacturing and analytical services
- FDA-registered and inspected facilities, including cGMP manufacturing suites, segregated Grade C/D clean rooms, warehouses, and cold storage
- cGMP-compliant analytical laboratory for drug product release and ICH stability testing
- Expertise with small molecule APIs, simple and complex formulations of highly potent compounds, and controlled substances
- Experience with formulation development and optimization of cannabinoids
- Experience developing methods for low concentration formulations often used for psychedelics
- Experience with all aspects of drug product characterization
- Clinical supply and commercial manufacturing, packaging, and shipping
- Regulatory and technical guidance and support
Get in touch with our experts today to discuss your project’s needs.
Got a few more minutes? You may also be interested in the following:
- Webpage: Pharmaceutical Contract Manufacturing and Analytical Services
- Webinar: The Many Facets of Early Phase Evaluation of Psychedelics in Psychiatry
- E-Book: The Benefits of Liquid-Filled Capsules in Pharmaceutical Development
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.
Nanomilling ― For Better Solubility and Improved Bioavailability
40% of marketed drugs and 90% of active pharmaceutical ingredients (APIs) are poorly water-soluble, BCS Class II or IV. Nanomilling is a proven technique that can overcome solubility challenges and ensure your molecules are developed successfully into life-saving therapies.
In our latest issue of The Altascientist, learn about:
- Solubility classifications (consult the checklist to see if your API qualifies)
- How nanomilling works
- The advantages of nanomilling
- Maximizing formulations
- A case study
Download your copy today, or listen to the audio recording.
Questions? Speak with our experts.
A Solution to Drive Your Drug Development Forward
Nonclinical and Clinical Research Services — Phase I to IV
Whether you are looking for a full-service solution or a stand-alone offering, Altasciences will help guide you along the way. We are accustomed to managing complex projects with different partners, and have robust communication and operational processes in place to ensure efficient integration.
We offer a range of services for early phase and late phase studies, including:
- Program Management
- Clinical Monitoring
- Scientific Publication Development and Review
- Protocol Development and Medical Writing
- PK/PD Analysis and Interpretation
- Data Management
- Biostatistics and Statistical Analysis
- Support Services for Non-Clinical Studies
Have 5 minutes? You may be interested in this:
- Clinical Trial Services
- Podcast — Choosing the Right CRO for Your Clinical Trial Monitoring
- Blog — Five Things You Need to Know About Partnering with an Integrated CRO/CDMO
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.
Manufacturing Solutions for Your Ophthalmic Products
Ophthalmic Drug Delivery
Altasciences’ CDMO experts can support your ophthalmic drug development program for a wide range of ocular diseases. We take you seamlessly from the clinic to market, with high-quality formulation development and manufacturing of various dosage forms, including liquids, gels, and injectables.
Altasciences’ specialties include:
- All small molecule ophthalmic products, including potent compounds and controlled substances
- GMP/GLP-compliant, FDA-registered facility, with DEA License for Schedules I-V
- Class C manufacturing suites for development and clinical/commercial batches
- Flexible filling options, including vials, tubes, multi-dose bottles, cartridges, pre-filled syringes, droppers, and custom containers
- Terminal sterilization of your ophthalmic drug products
- Scale options from small batches up to 400L
- Milling capabilities for micro and nanosuspension products
- Analytical support for method development, validation, and ICH stability testing
- High-performance, mucoadhesive topical excipients
- Bioadhesive, monograph-compliant topical excipients
- Packaging of your ophthalmic therapeutics
- Regulatory, scientific, and operational guidance
Book a consult with one of our experts to learn more about our solutions and how we can support your program.
You may also be interested in the following:
- Fact Sheet: Comprehensive Services for Ophthalmic Drug Development
- Webpage: Pharmaceutical Contract Manufacturing and Analytical Service
Did you miss our webinar titled “The Development of Nanosuspension Formulations for Poorly Soluble Drugs”? View it ON-DEMAND!
Experts in Complex and Customized Formulations
Over 80% of drugs will fail during clinical development due to formulation challenges. Having developed, tested, and manufactured almost every type of dosage form on the market, Altasciences has the expertise to customize our services to your API’s needs, taking it through its entire lifecycle and ensuring its successful delivery ― from prototype formulation development, to scale-up and ICH stability, to clinical manufacturing and commercial supply.
Our scientists tailor your drug compound to ensure optimal solubility and bioavailability. In addition, we have extensive experience handling complex and highly potent products. Finally, our state-of the art technology and banding equipment make us leaders in the development of hard-shell, liquid-filled capsules ― a dosage form often required for poorly soluble, highly potent or low dose APIs.
Partner with us today to reduce your development timelines and risk of product failure.
You may also be interested in the following:
Looking to Outsource Your Drug Development and Manufacturing?
Your Drug Development and Manufacturing Partner ― Altasciences at a Glance
Altasciences can support your drug formulation, development, and manufacturing needs, from formulation through to commercialization.
We excel in the full range of drug development and manufacturing solutions, including:
- Handling complex formulations and highly potent compounds (HPAPIs)
- Custom formulation development
- Manufacturing of liquid-filled, hard-shell capsules
- Nanomilling – to resolve solubility and bioavailability challenges
- Terminal sterilization
In addition, our integrated CRO/CDMO end-to-end solutions can reduce your drug development program timeline by up to 40% ― from discovery to preclinical to clinical proof of concept, and beyond.
Partner with us today.
Got a few more minutes?
| See our full range of drug development and manufacturing solutions. | Take a tour of our manufacturing facility and analytical laboratories. |
Did you miss our webinar titled “The Development of Nanosuspension Formulations for Poorly Soluble Drugs”? View it ON-DEMAND!