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Regulatory

Bioanalytical Strategies for Evaluating Immunogenicity in Next-Generation AAV Therapies

Bioanalytical Strategies for Evaluating Immunogenicity in Next-Generation AAV Therapies

Next-generation AAV (adeno-associated virus) therapies have recently emerged as a significant area of therapeutic innovation to address complex or inherited diseases. They offer a potential pathway to treat conditions once deemed untreatable through methods like replacement, inactivation, or introduction of new materials. Viral vectors are essential for delivering these advanced therapies, as they efficiently transport therapeutic material into target cells. Once inside the cell, the vector incorporates into the host’s natural machinery, enabling protein expression and facilitating treatment outcomes.

Advancing Oligonucleotide Drug Development with Ligand Binding Assays in the Preclinical Stage

Advancing Oligonucleotide Drug Development with Ligand Binding Assays in the Preclinical Stage

The development of oligonucleotide drugs has seen remarkable progress, driven by innovations in chemical modifications and delivery systems. These advancements have significantly enhanced drug stability, extended half-life, and improved targeting capabilities, increasing therapeutic efficacy and reducing dosage frequency. However, these benefits come with unique challenges in preclinical bioanalysis, particularly in pharmacokinetics (PK), drug metabolism, and tissue distribution studies.

Bioanalysis of GLP-1 Antagonist Drugs by Multiple Analytical Platforms

Bioanalysis of GLP-1 Antagonist Drugs by Multiple Analytical Platforms

Diabetes is classified into Type 1 diabetes mellitus (TIDM) and Type 2 diabetes mellitus (TIIDM) based on whether the patient has a deficiency in insulin secretion. TIDM is, on the one hand, characterized by destroying pancreatic beta cells that secrete insulin, mainly during childhood and adolescence. On the other hand, TIIDM is characterized by an imbalance between insulin levels and insulin sensitivity, resulting in persistent hyperglycemia. TIIDM is primarily found in middle-aged and elderly individuals. Globally, 90% of diabetes patients have TIIDM. Whether it is TIDM or TIIDM, if patients do not treat their hyperglycemia through appropriate medical interventions, they may face a series of severe consequences like blindness, kidney failure, or amputation.

Overcoming nonspecific binding challenges in PK assays

Overcoming nonspecific binding challenges in PK assays

Pharmacokinetic (PK) assays are a crucial stage of drug development. They help ensure the safety and effectiveness of new therapeutics by establishing how drugs are absorbed, distributed, metabolized, and excreted in the body.

Preclinical Strategies for Safety Evaluation of Oligonucleotide Drugs

Preclinical Strategies for Safety Evaluation of Oligonucleotide Drugs

Oligonucleotide drugs (ONs) are synthetic molecules ranging from 12 to 30 nucleotides in length and typically made up of single or double strands of nucleotides. Through Watson-Crick base pairing, these drugs use target messenger RNA (mRNA), which results in the inhibition of gene expression and the prevention of erroneous protein production.

Tackling Development and Regulatory Challenges for Gene Therapies

Tackling Development and Regulatory Challenges for Gene Therapies

Gene therapies have been one of the fastest-growing fields of drug development. These therapies hold the potential to treat cancers and other “undruggable” diseases and could hold the key to saving millions of lives. But they also have unique characteristics that make...

4 Reasons Non-GLP Bioanalysis Matters for DMPK Testing

4 Reasons Non-GLP Bioanalysis Matters for DMPK Testing

DMPK testing helps drug developers investigate how a drug compound is absorbed, distributed, metabolized, and eliminated (ADME) by the body. The earlier these properties can be understood, the better – which is why many drug developers start the process with non-GLP...

Improving PROTAC Drugs with MetID Studies

Improving PROTAC Drugs with MetID Studies

Most drugs undergo some level of transformation once they enter the body. This metabolism process allows a drug's active pharmaceutical ingredient (API) to achieve its desired effect and eliminate it from the body. But metabolism can also be tricky. Metabolizing a...