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Chemistry manufacturing control (CMC)

Articles  —  27 September Sep 2025

eBOOK: mRNA-LNPs for vaccine and gene therapy indications

Read More about eBOOK: mRNA-LNPs for vaccine and gene therapy indications
Articles  —  24 July Jul 2025

Gene therapy in-use and device compatibility studies

Read More about Gene therapy in-use and device compatibility studies
Articles  —  2 July Jul 2025

Analytical procedure development following ICH Q14: An AQbD approach

Read More about Analytical procedure development following ICH Q14: An AQbD approach
Articles  —  12 September Sep 2024

Why cell line screening is crucial for successul complement-dependent cytotoxicity (CDC) assay development

Read More about Why cell line screening is crucial for successul complement-dependent cytotoxicity (CDC) assay development
Articles  —  12 September Sep 2024

N-Glycan Characterization with LC-MS

Read More about N-Glycan Characterization with LC-MS
Articles  —  12 September Sep 2024

Centralized Analytical Laboratory White Paper

Read More about Centralized Analytical Laboratory White Paper
Articles  —  12 September Sep 2024

Labcorp Biopharmaceutical CMC Stability Services

Read More about Labcorp Biopharmaceutical CMC Stability Services
Articles  —  7 December Dec 2023

Potency assays 101: How to develop a CMC relative potency assay

Read More about Potency assays 101: How to develop a CMC relative potency assay
Articles  —  6 December Dec 2023

A stability screening method for predicting colloidal stability: Diffusion interaction parameter thermal shift assay

Read More about A stability screening method for predicting colloidal stability: Diffusion interaction parameter thermal shift assay
Articles  —  6 December Dec 2023

Identification and quantification of host cell proteins in biopharmaceutical products

Read More about Identification and quantification of host cell proteins in biopharmaceutical products
Articles  —  6 December Dec 2023

Forced degradation of biopharmaceuticals: Protein stress testing

Read More about Forced degradation of biopharmaceuticals: Protein stress testing
Articles  —  16 November Nov 2023

Cell and gene therapy answers: Assessing the critical quality attributes, challenges and importance of CMC

Read More about Cell and gene therapy answers: Assessing the critical quality attributes, challenges and importance of CMC
Articles  —  27 September Sep 2023

ICH Q14 101: Applying AQbD to CMC for Regulatory Success

Read More about ICH Q14 101: Applying AQbD to CMC for Regulatory Success
Articles  —  17 May May 2023

Subunit vaccine formulation: Evaluating the effect of formulation on the uptake of recombinant antigen by dendritic cells

Read More about Subunit vaccine formulation: Evaluating the effect of formulation on the uptake of recombinant antigen by dendritic cells
Articles  —  7 April Apr 2023

mRNA-lipid nanoparticles: Quality control releasing testing and characterization

Read More about mRNA-lipid nanoparticles: Quality control releasing testing and characterization
Articles  —  7 April Apr 2023

20 critical questions: Helping you optimize reference standards for your biopharmaceutical across its development life cycle

Read More about 20 critical questions: Helping you optimize reference standards for your biopharmaceutical across its development life cycle
Articles  —  20 March Mar 2023

Labcorp Drug Development enhanced vaccine delivery model

Read More about Labcorp Drug Development enhanced vaccine delivery model
Articles  —  15 March Mar 2023

Expediting a pediatric vaccine trial through site- and participant-centric practices

Read More about Expediting a pediatric vaccine trial through site- and participant-centric practices
Articles  —  10 October Oct 2022

Designing a high-touch, low-burden pediatric vaccine study with powerful digital solutions

Read More about Designing a high-touch, low-burden pediatric vaccine study with powerful digital solutions
Articles  —  22 September Sep 2022

Characterizing the effector functions of therapeutic antibodies

Read More about Characterizing the effector functions of therapeutic antibodies
Articles  —  19 September Sep 2022

Cell and Gene Therapy - High Quality and Safety from Vein to Vein: CMC Testing for CAR T-Cell Therapies

Read More about Cell and Gene Therapy - High Quality and Safety from Vein to Vein: CMC Testing for CAR T-Cell Therapies
Articles  —  22 December Dec 2021

Cell and Gene Therapy Answers: Assessing the Critical Quality Attributes, Challenges and Importance of CMC

Read More about Cell and Gene Therapy Answers: Assessing the Critical Quality Attributes, Challenges and Importance of CMC
Articles  —  29 January Jan 2021

Potency Assays 101: How to Develop a CMC Relative Potency Assay eBook

Read More about Potency Assays 101: How to Develop a CMC Relative Potency Assay eBook
Articles  —  28 February Feb 2020

ATMP Potency Assay Strategies: Adding Value to Your Asset and Avoiding Delays in Development

Read More about ATMP Potency Assay Strategies: Adding Value to Your Asset and Avoiding Delays in Development