Analytical Testing in Pharmaceutical Development

Analytical testing plays a pivotal role in all phases of pharmaceutical development and is one of the most outsourced services among drug developers today. 

At Altasciences, we use the latest instrumentation to support your drug development and manufacturing, no matter how complex or challenging your molecule is. Our robust analytical procedures ensure the quality of your raw, in-process, or finished product, and provide method development and validation to meet the ever-evolving requirements of regulatory agencies worldwide.

We provide you with:

• Method development, qualification, and validation
• On-site ICH stability testing and storage
• Controlled substance testing
• Excipient and active pharmaceutical ingredients (APIs)
• Drug product release and stability testing

Discover our full array of analytical solutions, or speak with one of our experts to get started.

Let’s chat.

You may also be interested in:

• A virtual tour of our analytical laboratories 
• Our full range of manufacturing and analytical solutions

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.

The importance of working with a drug development and manufacturing consultant

In this podcast with Dr. Daniel E. Levy, we uncover the key considerations when putting together your drug development and manufacturing program, the importance of securing a drug development and manufacturing expert, and the most important things to look for in an integrated CRO/CDMO partner.

Listen to the podcast!

You may also be interested in the following:

WEBINAR ― Join Altasciences and Prince Terminal Sterilization for a complimentary webinar to find out why the FDA and EMA recommend terminal sterilization over aseptic manufacturing, and its many advantages for your drug products. 

REGISTER NOW

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. Our experts in pharmaceutical contract manufacturing and analytical testing are ready to support you for formulation, method development and validation, clinical trial supply, and commercial batch manufacturing. We have tested or manufactured almost all available dosage forms on the market, including liquid- and powder-filled capsules, nano-milled suspensions, creams, gels, and terminally sterilized injectables.

Manufacturing and Handling Highly Potent APIs and Controlled Substances

With more highly potent APIs (HPAPIs) coming through the R&D pipeline than ever before, it has become increasingly important to partner with the right CDMO to rapidly formulate and manufacture your HPAPIs for preclinical, clinical, and commercial development. 

In this Quick Chat video with Ben Reed, learn how Altasciences, a fully integrated CRO/CDMO, handles the most challenging drug substances, from early phase development to commercialization, including:

• Industry-leading technologies used for formulation, containment, and sterilization
• Seamless shipping and handling of your HPAPIs and controlled substances
• Safety procedures and protocols

Watch it now!

Have questions? Speak with our experts.

You may also be interested in the following:

• Webpage: Pharmaceutical Contract Manufacturing and Analytical Services
• Webinar: The Development of Nanosuspension Formulations for Poorly Soluble Drugs
• 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.

Advantage of Liquid-Filled Capsules in Drug Development

Choosing the right dosage form for your API can be the key to accelerating your drug development timeline.

Liquid-filled, hard-shell capsules offer countless benefits over tablets and other solid oral dosage forms, in all phases of drug development ― especially for highly potent or challenging APIs.

View the infographic to learn more!

Have questions? Speak with one of our experts.

You may also be interested in:

• Webpage: Full Range of Manufacturing and Analytical Services
• Video: Quick Chat on Liquid-Filled Capsules with Ben Reed, General Manager, CDMO
• Webinar: The Development of Nanosuspension Formulations for Poorly Soluble Drugs

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.

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:

Speak with a scientist

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.

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.

Listen now!

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.

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.

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.