Bioanalysis
A Multi-Peptide Hybrid LC-MS/MS Assay for the Determination of CTI-1601 in Monkey Tissues Provides Insight into its Disposition and Processing
Understanding Vaccines and Immunization
Your Immune System is your Body’s Defense Against Infection
You may already know that vaccines wor
Quantitation of a PEGylated Human Parathyroid Hormone (1-34) Analog in Rat Plasma Using a Hybrid Immunoaffinity Bottom-Up LC-MS/MS Assay
The Application of Light-Absorbing Photostabilizers for the Determination of Protoporphyrin IX in Human Plasma by LC-MS/MS
Overcoming Recovery Challenges in Hemolyzed Samples for the Determination of Propafenone and 5-Hydroxy Propafenone by LC-MS/MS
Method Development for the Detection of Exicure’s AST-008 in Human Plasma
A Lesson in Adaptability for the Determination of Rifampin
ISSUE NO. 8 — Bioanalytical Challenges Encountered when Developing ADA Assays
Following the approval in 1986 of Orthoclone OKT3, the first therapeutic monoclonal antibody product, a class of new protein-based therapeutic drugs was introduced and became the dominant product class within the biopharmaceutical market.
Today, several monoclonal antibodies have been approved for the treatment of a variety of diseases, ranging from those that target orphan disease indications with a small patient population, to those that target much larger patient populations and demographics, such as for oncology, asthma, and rheumatoid arthritis.
In Issue 8 of The Altascientist, we explore the role of anti-drug antibodies (ADAs) in therapeutic development, their impact on efficacy, and detection strategies, including:
- Challenges encountered in ADA assays
- Cell-based or non-cell-based assays to measure neutralization
- How Altasciences can help
ISSUE NO. 4 — Key Considerations for Biosimilar Clinical Pharmacology Studies
Biologics have become the fastest-growing class of therapeutic compounds, with seven of the top-10 selling drugs in 2023 being biologics, each exceeding sales of $10 billion USD. In 2022, biosimilars accounted for 13.7% of all spending on biologics, compared with the 8.9% in 2021.
Biologics have provided treatment options for people who suffer from some of the most serious medical conditions, such as cancer and genetic disorders.
A biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original medicine. It enters the market subsequent to the patent expiration of a previously authorized version of a biologic. A biosimilar is approved only after showing that it is “highly similar” to an approved biological product, known as the reference product, in terms of structure, purity, potency, safety, pharmacokinetics, and in many cases, efficacy, with allowable minor differences.
In Issue 4 of The Altascientist, learn about the growing interest of biosimilars, and key considerations in pharmacokinetic (PK) studies, as well as:
- The rise of the biosimilar market
- The regulatory landscape
- How Altasciences puts biosimilars to the test
- Altasciences’ expertise in bioanalysis
- Key considerations for biosimilar clinical pharmacology studies
- Ensuring the continued success of biosimilar programs
Considerations and Study Challenges for Biosimilars
Early awareness of study challenges is crucial in running a successful early-phase biosimilar development program, and certain considerations must be taken into account before beginning a study.
Selective Quantitation of 1,3-Propanediol in Dog Plasma Using Differential Ion Mobility Spectrometry