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Trade Articles

Pharma Manufacturing | July 2024

What USP <665> means for the future of pharma manufacturing

American Pharmaceutical Review | August 2024

Tailored Treatment: Biomarkers and the Path to Precision Medicine Based on a ‘Fit-for Purpose’ Strategy

American Pharmaceutical Review | July 2024

Optimizing ADC Bioassays: LC-MS/MS Blends Speed with Cost-Effectiveness

Contract Pharma | June 2024

Exploring Oligonucleotide Drugs: An Overview of Pharmacokinetic & Bioanalytical Strategies

Drug Discovery and Development | May 2024

Beyond chemotherapy: The rise of precision medicine with radionuclide drug conjugates

Pharmaceutical Outsourcing | February 2024

How a New Rapid EMSA Method is Impacting Plasma Protein Binding in Oligonucleotides

Drug Discovery and Development | December 2023

Integrated bioanalysis strategies in nonclinical early in-vivo PK studies of siRNAs

Drug Discovery and Development | November 2023

Anticipating IND submission: Ensuring your drug is ready for preclinical toxicology studies

Outsourcing Pharma | September 2023

A deep dive with WuXi AppTec into HPAPIs: Risks, regulations, and revolutionary applications

Medical Design Sourcing | July 2023

Bridging bioanalytical gaps: Examining validation methods across species

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Drug Discovery and Development | April 2023

Development challenges and regulatory changes for cell and gene therapies

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ONdrugDelivery | March 2023

Overcoming challenges when developing oligonnucleotides for opthalmic drugs

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Drug Discovery and Development | February 2023

Overcoming the challenges of metabolite identification and profiling for developing oligonucleotides

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Drug Discovery and Development | November 2022

How MetID studies can improve safety and efficacy in PROTAC drugs

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GEN News | November 2022

Bioanalysis Considerations for CAR T-Cell Therapies

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Contract Pharma | October 2022

Comprehensive Bioanalysis of ADCs in DMPK Studies

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OnDrug Delivery | August 2022

Dissecting the Delicate Delivery Process for Ocular Gene Therapy

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American Pharmaceutical Review | August 2022

Antibody-Drug Conjugates (ADCs): Potent Cancer Killers with PK Challenges

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Bioanalysis Zone | June 2022

Utilizing Monoclonal Antibodies to Regulate Checkpoint Proteins & Boost Immune Response

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Drug Discovery & Development | February 2022

5 questions drug developers need to ask when vetting laboratory testing partners

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Pharmaceutical Outsourcing | May 2022

Protein Biomarkers: The Correlation Between Proteins, Health Conditions and Exogenous Products

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Contract Pharma | June 2022

Changes are on the Horizon for Single-use Systems in Pharmaceutical Manufacturing

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American Pharmaceutical Review | December 2021

Improving Preclinical Outcomes: De-Risking Your Drug Development Program

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Contract Pharma | June 2021

Preparing for Preclinical Testing: A Readiness Checklist

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Life Science Leader | May 2021

Improving Submission Quality: Preparing For Regulatory Differences

Drug, Discovery & Development | August 2024

Key toxicology considerations for large molecule therapies

Drug Discovery and Development | July 2024

Preparing for the golden age of small molecule oncology drugs

OutsourcingPharma | June 2024

Examining the Impact of Personalized Medicine on Reproductive Health

MedTech Intelligence | April 2024

From Concept to Market: The Strategic Journey from IND to NDA

American Pharmaceutical Review | February 2024

Embracing the Future: How In Vitro Assays Are Transforming Nonclinical Toxicology

Contract Pharma | January 2024

Stability Testing for Drug Products: Ensuring Safety, Efficacy & Regulatory Compliance

Drug Discovery and Development | November 2023

Unlocking the secrets of cellular immunogenicity: A deep dive in ELISpot assays

Drug Discovery and Development | September 2023

Exploring future cancer therapies: Designing linkers to increase ADC efficacy and reduce toxicity

Pharmaceutical Outsourcing | August 2023

The Role and Challenges of Plasma Protein Binding in Oligonucleotide Drug Development

Drug Discovery and Development | July 2023

Bridging bioanalytical gaps: Examining validation methods across species

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Pharma Manufacturing | March 2023

Streamlining HPAPI development: How to manage highly potent APIs through a preclinical testing process

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ONdrugDelivery | February 2023

Extractables/Leachables Testing Considerations For Single-Use Systems

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Drug Metabolism and Disposition | January 2023

Detection and characterization of in vitro payload-containing catabolites of non-cleavable ADCs by high-resolution mass spectrometry and multiple data-mining tools

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Bioanalysis Zone | November 2022

Bioanalytical considerations for gene and cell therapeutic products

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Drug Discovery and Development | October 2022

Preparing an IND submission: Here is what drug sponsors should anticipate

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Bioanalysis Zone | August 2022

Examining the dominant bioanalytical methods for Oligo development

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Drug Discovery & Development | July 2022

Bioanalytical method development and validation using Quanterix’s Simoa platform

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Drug Discovery & Development | December 2021

The opportunities and challenges inherent in using protein biomarkers for new drug development

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Genetic Engineering and Biotechnology News | November 2021

Using In Vitro–In Vivo Extrapolation to Predict Human Clearance

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Drug Discovery & Development | May 2021

Managing critical reagents through drug development

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Drug Discovery & Development | April 2021

Analyzing FDA guidance on DDI studies for therapeutic proteins

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PharmaManufacturing | March 2021

Winning the drug development relay

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Regulatory Focus | June 2021

The transition to ICH M10 and its impact on global submissions

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AAPS Journal | May 2021

Bioanalysis in the Age of New Drug Modalities