Newsletter | June 8, 2023

06.08.23 -- Ensure Protein Stability Through Biophysical Characterization

Achieving A Successful Drug Product Technology Transfer

Technology transfer is a challenging and multifaceted endeavor, with multiple variables that must be carefully considered. Get insights on key considerations for a successful process transfer for manufacturing a drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

Biologics Drug Product: Formulation, Tech Transfer, Delivery Strategies

As the biologics industry continues to grow, it's important to understand your products’ characteristics and formulation aiding in successful tech transfers and life cycle management transitions. Review key considerations for formulation screening of therapeutic proteins and how consistency, planning, and communication are essential for a successful biologic product tech transfer.

Characterizing A Therapeutic mAb, Associated Antigen-Binding Fragments

Determining size homogeneity of a mAb in solution is important for comparability and characterization. For this study, an IgG1 antibody was cleaved into antigen-binding fragments followed by Protein A purification. Learn about the results from the study and characterization of size and distribution of the intact mAb and enzymatic fragments.

Advancements In ADCs Using SMARTag Technology

Find a one-step toolkit to develop optimized ADCs and bioconjugates. SMARTag technology enables site-specific, controlled drug-protein conjugation and uses only naturally occurring modifications to proteins requiring minimal cell-line engineering.