Join Dr. Anahita Keyhani for a discussion on proactive, effective, and efficient bioanalytical project management, and the positive impact it can have on your drug development program.
 
Topics covered include:

• The framework for successful bioanalytical support at various phases and for different types of studies
• Bioanalytical critical control points (operational, logistical, technical, and scientific) to proactively manage for successful project progression
• Bioanalytical communication flow and key stakeholders for different types of studies

Watch the webinar

You may also be interested in the following:

• Fact Sheet: Clinical Sample Kits
• Webpages: Bioanalytical Services
• Webinar: Critical Sample Handling Processes for Preclinical and Clinical 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.

Regulated bioanalytical development for the analysis of antisense oligonucleotides (ASOs) is showing promise in therapeutic applications for a number of diseases.  

From preclinical to clinical, Altasciences has significant expertise in supporting robust and sensitive bioanalytical assays that minimize interference, for accurate quantification of ASOs in complex biological tissues.

In the last couple of years, our bioanalytical scientific experts have developed close to 100 assays of various matrices, supported close to 100 preclinical and clinical studies at various stages, and analyzed over 15,000 samples in oligonucleotide quantitation.

Speak with an expert today to ensure you are provided with the best bioanalytical techniques for your ASO drug development program.

Speak with an expert today

You may also be interested in the following:

• The Altascientist: Antisense Oligonucleotides
• Webinars:
  • Assessing Cognition and Driving Ability in Clinical Pharmacology Studies
  • Quantitation of Passive Immunotherapeutic Agents for COVID-19 by LC-MS
• Webpages:
  • Preclinical Solutions
  • Clinical 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.

Altasciences’ offers scalable flow cytometry solutions, and leverages extensive knowledge to help ensure a smooth transition from preclinical to clinical studies. We provide you with:

• Dedicated flow cytometry scientists available to you early in the process to help determine the most appropriate strategy for non-GLP, GLP, and GCP testing
• Extensive knowledge with exploratory and GLP studies from panel development to validation
• Design and development of receptor occupancy (RO) assays
• Strategically located laboratories in both the U.S. and Canada.
• State-of-the-art instrumentation
• Rapid turnaround between sample collection and analysis

Altasciences has the same instrumentation in its U.S. preclinical site and Canadian site, which allows assay transfer for easy transition from preclinical to clinical studies.

Download flow cytometry fact sheet

Speak to a flow scientist for guidance on your assay development or validation strategy.

You may also be interested in the following:

• Webpage: Therapeutic Areas of Clinical Research
• Fact Sheet: First-in-Human Trials Capabilities
• The Altascientist: Facing Bioanalytical Challenges

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.

As an alternative to traditional venipuncture, blood microsampling represents a less invasive and simplified collection technique, resulting in numerous benefits for preclinical and clinical studies alike.

Microsampling in safety testing supports Altasciences’ commitment to the 3Rs: replace, reduce, and refine experimental animal use. It also provides other advantages, such as:

• Accelerated animal recovery due to rapid blood collection
• Direct correlation of study findings with PD and toxicological effects given the use of main study animals 
• Less variability in PK profiles when derived from individual animals versus composite profiling  
• Collection of additional PK/TK timepoints
• Biomarkers and metabolites detection that aids interpretation of toxicological effect 
• Reduced animal numbers saves on costs and time

Speak with one of our microsampling experts today.

You may also be interested in the following:

• Webpages:
  • Microsampling Benefits
  • Preclinical Services
• Videos:
  • Altasciences’ Animal Welfare Program
  • Your Road to Proactive Drug Development with Altasciences

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.

A generic molecule with a different route of administration, format, strength, or indication from the original reference product requires re-approval for market authorization, partly based on data from the original medicine, and partly on data from new clinical trials on the modified version.

Consult The Altascientist for a review of the requirements for such approval, including a case study outlining three key studies we conducted for a 505(b)(2):

Altasciences ensures a seamless process for your 505(b)(2) or Hybrid medicine submissions, with integrated manufacturing, bioanalysis and comprehensive research support services that can expedite your clinical trials.

Speak with our experts.

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.

You may also be interested in the following:

• Video (3 minutes): Fully Integrated Drug Development Solutions
• Fact Sheet: Multiple Award-Winning CRO
• On-Demand Webinar: Patient Centricity and the Evolving Role of Microsampling

Altasciences’ analytical laboratory services teams support a full range of pharmaceutical and nutritional supplement testing capabilities, as stand-alone or as part of an integrated service offering, including:

• APIs, excipients, and packaging components
• Drug product release and stability testing
• Analytical method development, qualification, and validation
• On-site ICH stability storage and testing

Join our Executive Vice President of Operations, Ben Reed, on an exclusive virtual tour of our state-of-the-art analytical laboratory, and learn about the advanced equipment and techniques used by our scientists to ensure the quality and success of your drug development program.

Want a more in-depth virtual or in-person tour of our 64,000-square-foot manufacturing facility? Request one here.

Questions? Speak with an expert.

You may also be interested in the following:

• Webpage:  Pharmaceutical Contract Manufacturing and Analytical Services
• Fact Sheet: Pharmaceutical Analytical Services
• Webpage: Bioanalytical Services

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.

Trying to select the right bioanalytical platform for your molecule isn’t obvious. Altasciences’ team of scientific experts can help expedite your research goals by proactively advising the best pathway for your unique molecule.

Download this list of key considerations
for selecting the right bioanalytical platform.

You may also be interested in the following:

• Fact Sheets:
  • Ligand Binding Assays Capabilities
  • Bioanalysis of Small Molecules Using Mass Spectrometry
• The Altascientist: Microsampling in Drug Development
• Webinar: Quantitation of Passive Immunotherapeutic Agents for COVID-19 by LC-MS

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.

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:
  • Bioanalytical Services
  • Proactive Drug Development
• 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 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.

Contact our Experts

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.

We are your one-stop solution for all your bioanalytical needs. We offer fully integrated bioanalytical laboratories that support our facilities and clinical sites. Most importantly, we ensure the success of your projects by anticipating challenges throughout the process with:

• A team of industry recognized, subject matter experts specialized in both small and large molecules
• 25+ years of regulatory experience
• Strategically located facilities situated in proximity to preclinical and clinical sites 
• A history of successful regulatory inspections
• Industry leading experience with GLP and GCP regulatory processes
• In-depth knowledge and experience with preclinical, first-in-human SAD/MAD, and Phase III bioanalytical study management and timelines

Partner with Altasciences today.

You may also be interested in the following:

• Factsheets:
  • Bioanalysis of Small Molecules Using Mass Spectrometry 
  • Bioanalysis Ligand Binding Assays
• Video: Bioanalysis Services
• Webinar: Transitioning Novel Scientific Workflows to Routine Bioanalysis

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.