Newsletter | December 9, 2021

12.09.21 -- Immunosafety, IND Submissions, Complex Biotherapeutics, & Bispecific Antibodies

 
What Can You Do To Overcome Immunogenicity And Immunotoxicity Assessment Challenges?
 

In addition to threatening the safety of patients, drug candidates that fail because of immunosafety issues also cost drug developers significant losses in time and money. Assessing immunogenicity and immunotoxicity potential at the earliest possible stage is critical.

IND Submissions In China: What's Different From Other Regions?
 

This is a new era for many companies, as the number of regulatory submissions to China is increasing. This webinar provides an overview of the China regulations with a specific focus on data and regional requirements for clinical trial applications.

Early Developability And Analytical Toolbox For The Production Of Multichain Biotherapeutics
 

In recent years, the number of biotherapeutic molecules requiring more complex assemblies has greatly increased. These multichain molecules typically require a more agile approach to early developability and method development.

Immunogenicity Assessment: Support For Regulatory Submission And Feedback By Applying State-Of-The-Art In Silico And In Vitro Tools
 

Assessing your drug candidate’s immunogenicity potential is essential in preclinical development. To support your regulatory filing, you need to generate reliable, high quality data. Watch our presentation where we share our experience in assessing immunogenicity for regulatory submission.

Development And Manufacture Of Biopharmaceuticals Produced In Microbial Systems
 

Explore the trends in new molecular formats, one of the current drivers of renewed interest in fermentation technologies, and some of their challenges, along with considerations for an early process development strategy to plan a program with the end goal in mind.

Trends, Challenges, And Opportunities In Bispecific Antibodies
 

Hear about trends in bispecific research and development, the hurdles and opportunities they present, and how young companies can optimize their development approach.

CEO Perspectives: Individual Journeys To Advance Molecules
Video: A Successful Small Biotech-CDMO Relationship

Simon Westbrook had an idea for a complex fusion chimera protein he believed could interrupt the neurotrophin pathway and have a profound impact on chronic pain and joint degeneration in osteoarthritis patients. He formed Levicept to develop this idea, and, being a true virtual company, he needed a CDMO.

Read the full case study
 
Video: A Small Biotech With Two Complex Bispecific Antibody Candidates

Surrozen is a small biotech developing novel and complex bispecific antibodies that target activation of the WNT pathway to take advantage of its regenerative potential. Although the WNT pathway has been studied for decades, Surrozen is aiming to develop the first therapeutics that intervene in this pathway and only in diseased tissue.

Read the full case study
 
Video: A Small Biotech Develops A Monoclonal Antibody For Oncology Treatment

Corvus, a small biotech developing precision medicines, primarily for oncology patients, was seeking to develop a monoclonal antibody called CPI06, now known as Mupadolimab. This inhibits the production of adenosine in the tumor microenvironment and has an agonistic effect on B cells.

Read the full case study