FEATURED ARTICLES

• Accelerating Bulk Harvest Testing Using A CHO Animal Origin Free Virus Panel

  Here, we describe the design and performance of a degenerate PCR-based approach to broad virus screening that can be used in testing bulk harvest material derived from CHO cells.

• Determining RNA Integrity And Purity By Capillary Gel Electrophoresis

  To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.

• Lipid Nanoparticle Compositional Analysis By UHPLC-CAD

  Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.

• Establishing Analytical Methods For mRNA-Based Therapies

  Here, we provide a detailed description of assays for sequence identification and LNP composition, two CQAs of mRNA-LNP products, that support the development of safe and effective mRNA therapies.

• Orthogonal Methods To Understand And Define CQAs Of AAV Therapies

  An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.

• Next Generation Sequencing For Adventitious Agent Detection In Cell Banks

  NGS-based methods for agnostic broad range detection are suitable options to augment or replace current virus testing methodology. Explore a NGS AAT method for cell line characterization and more.

• Transition To Closed Processing Systems

  Learn about one facility's transition to closed processes for the expansion of suspension CHO and Sf9 cells and how the closed system compares to traditional processing.

• Taking Charge Of Your Stability Program

  Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.

• Higher Order Structure Of Proteins By Circular Dichroism Spectroscopy

  Learn more about the analytical development for mAbs and recombinant proteins

• COVID-19 Impact To Biological Drug Products Safety

  Review currently available literature and our recommended COVID-19 virus detection test methods and susceptibility of common biological host cells to infection.

• Quantitation Of Retrovirus-Like Particles (RVLPs) In CHO Derived Products

  Review key methods which are applied to ensure safety of such recombinant proteins, with a focus on alternate and superior methods to the standard transmission electron microscopy (TEM) method.

• Regulatory Considerations For Alternative Microbial Methods

  We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.

• Designing Successful Viral Clearance Studies

  We review studies that involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step, and measuring the remaining virus.

• Blazar® Platform: Rodent Virus Panel From The BioReliance® Portfolio

  Did you know about the alternative rapid method for in vivo MAP/HAP/RAP testing? Download our tech note Blazar® Platform: Rodent Virus Panel From The BioReliance® Portfolio to learn more about our novel degenerate PCR assay designed for the detection of a broad range of adventitious agents.

• Blazar Platform: Rodent Virus Panel

  By amplifying multiple targets within a conserved region of the viral family genome, Blazar detects a much broader range of adventitious viruses as compared to traditional polymerase chain reaction methods.

• Not Everyone Loves Surprises: Know Your ADC’s CQAs

  Combatting the challenges of developing and manufacturing antibody-drug conjugates (ADCs) requires robust product characterization throughout all phases of development.

• Cell Based Potency Assay In Functional Characterization Of mAbs

  Because characterization and comparison of originator and biosimilar candidate mAbs is challenging due to their complex and variable structures, a range of analytical techniques should be employed.

• Early Product Characterization De-Risks Biologics Development

  The relationship between physicochemical profile and biological activity — and how this relationship affects clinical performance — is key to informed decisions, accelerated development, and risk reduction.

• Meeting Stability Testing Expectations In A Complex Pharma Landscape

  What was once a check-the-box procedure in standard stability testing now requires a deeper understanding of the molecule, its behavior, and what effect it has on the patient.

• Accelerate CHO Cell Characterization With The Blazar® Rodent Panel

  The Blazar Rodent Panel allows biopharma to move away from traditional in vivo antibody production assays when characterizing cell banks of rodent origin used in the production of biologicals.