In this issue, we describe the numerous benefits of incorporating a stable isotope labelled internal standard for quantitative liquid chromatography-mass spectrometry, and detail recent advances in MS technology. Several case studies are presented, which exemplify novel bioanalytical workflows that are required to meet the challenges faced in both non-clinical and clinical development, across a variety of drug classes.

- 0:42 Introduction
- 5:33 The Case for Stable Isotope Labelled Internal Standards for LCMS Quantitation
- 8:34 Recent Innovations in Mass Spectrometry
- 15:38 Case Study: Dried Blood Microsampling
- 17:14 Case Study: Anti-Epileptic Drug Panel
- 19:17 Case Study: COVID-19 Neutralizing Monoclonal Antibody
- 21:16 Case Study: Differential Mobility Spectrometry (DMS)
- 23:49 Case Study: Bioequivalence 
- 26:22 Case Study: Oligonucleotides
- 33:57 Conclusion

Click here to download a readable, PDF version of Issue 13: https://www.altasciences.com/sites/default/files/2022-12/The-Altascientist-issue-30-LCMS.pdf

About Altasciences:

Altasciences is an integrated drug development solution company 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.

Issue 30 — The Evolution and Advancement of LCMS in Drug Development

The different parts of the nervous system (or CNS for short), including the brain and spinal cord, and the peripheral nervous system, are important drug targets for many serious diseases affecting human health. As the body’s processing center, the CNS is responsible for all functions of our bodies, including thoughts, emotions, memories, and behaviors. Unsurprisingly, drugs working on the CNS are subject to stringent regulatory requirements, and specialized safety assessments are often mandated. To confirm CNS activity without safety concerns, dedicated nonclinical and early phase clinical studies, with relevant endpoints and biomarkers, and supporting bioanalysis, are needed; and drug manufacturing must be carefully managed via rigorous handling and production processes. 

Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely sharing of data at every step of the drug development plan, and facilitate agile, flexible decision-making and planning.

CHAPTERS:
- 1:22 — Introduction
- 3:53 — Preclinical Safety and Toxicity Testing of CNS-Active Molecules
- 12:28 — Preclinical Case Study
- 15:11 — Manufacturing CNS-Active Drugs for Trials and Commercialization 
- 21:48 — CDMO Case Study 
- 24:39 — Maximizing Early Phase Clinical Trials of CNS-Active Drugs
- 34:02 — Clinical Case Study
- 36:27 — Bioanalysis for CNS Drug Development (Preclinical to Phase IV)
- 42:26 Altasciences' CNS Center of Excellence

Issue 33 — CNS Drug Development: Integrated Solutions Lessen Complexity

In this episode, podcast host Dr. Dwight Stoll talks with Dr. Emanuella Gionfriddo, associate professor in the Department of Chemistry at the University of Toledo, Ohio. Dr. Gionfriddo is an expert in bioanalysis and analyte extraction technologies, and works on both the development of new technologies, and the application of those technologies to contemporary analytical challenges. In their conversation, they discuss the origins of Dr. Gionfriddo’s interest in science, and several recent papers, including topics including extraction of neurotoxins from water, markers of hydraulic fracturing activity in wastewater, and development of thin-film extraction for improved performance of DNA amplification assays. Finally, Dr. Gionfriddo shares several pieces of advice for young and aspiring scientists.

Ep. 14: The more diverse is your toolbox, the more analytical problems you can solve

In this issue, we will review the applications of PCR analysis for your gene therapy programs, and present two case studies.

Click to read this audiobook: https://www.altasciences.com/sites/default/files/2023-10/the-altascientist-issue-37-pcr_4.pdf 

Gene therapy continues to accelerate through preclinical and clinical research arenas. These programs are developed with targeted and personalized medicines in mind. The goal of gene therapy is to safely deliver and incorporate a genetic alteration to restore or repair the protein of a missing or faulty gene. Preclinical assessments of gene therapies consider the general absorption, distribution, metabolism, and excretion of the drug, as well as data from tailored assessments to evaluate delivery and cell incorporation. 

Gene therapies require, by design and definition, DNA and/or RNA delivery and analysis. While most ongoing research involves gene therapies being delivered in vivo via adeno-associated viral (AAV) vectors, new in vivo delivery mechanisms are on the rise, such as other types of delivery vectors including lipid nanoparticles.

CHAPTESR: 
- 0:05 — About Issue 37
- 1:20 — Introduction to qPCR, dPCR, and RT-PCR 
- 5:58 — Utility of qPCR, ddPCR, and RT-PCR 
- 8:19 — PCR Applications 
- 10:01 — Advantages and Applications 
- 17:45 — Case Study 1 
- 20:20 — Case Study 2 
- 22:47 — Conclusion

About Altasciences:

Altasciences is an integrated drug development solution company 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.

Issue 37 — Quantitative PCR and Droplet Digital: Analysis for Your Gene Therapy Programs

Current and future development of glucagon-like peptide-1 receptor agonists, more commonly referred to as GLP-1 RAs, or simply as GLP-1s, involves complexities not only in formulation but in all areas of early-phase drug development. Developing and refining preclinical models for early efficacy signals, developing and validating the bioanalytical assays necessary for quantitation, and designing the clinical studies that deliver the most robust data in this innovative therapeutic area are all key elements of a drug development program.

In this audiobook, we review the requirements for successful GLP-1 drug development, from the perspective of preclinical studies, clinical trials, manufacturing, and bioanalysis. Exclusive case studies are also presented.

Issue 42 — Managing the Complexities of Glucagon -like Peptide-1 Receptor Agonist Drug Development

Analytically Speaking, the podcast from LCGC and Spectroscopy magazines, addresses important issues in separation science and analytical spectroscopy. Topics include new analytical techniques, methods, and approaches; the latest trends; advances in instrument and software technology; practical solutions for specific applications; recent papers in the scientific literature and their applicability; challenges and solutions for data analysis and interpretation; analytical chemistry theory and fundamentals (from advanced research to tutorials and troubleshooting); and more. Our regular hosts are Dwight Stoll, PhD, a professor of chemistry at Gustavus Adolphus College in St. Peter, Minnesota, and Jerry Workman, PhD, a spectroscopist, noted author, and currently the Senior Technical Editor of Spectroscopy and LCGC. Dwight covers separation science and Jerry addresses spectroscopy related topics.

As an end-to-end CRO/CDMO, we have expert knowledge in all early stages of drug development, and we’re sharing that knowledge with you in The Altascientist: The Audiobook. 

Each issue is a deep dive into a specific area of early-phase drug development, providing insider tips, considerations, and case studies. 


Altasciences is a drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

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