Evolving CMC Analytical Techniques for Biopharmaceuticals
1.0 Abstract
During the (early) preclinical drug development process as well as manufacturing of biopharmaceutical (protein) products, analysis and characterization...
Outsmarting Cancer – From the War on Cancer to the Cancer Moonshot
On May 25, 1961, President John F. Kennedy announced, before a special joint session of congress, the dramatic and...
When Data Integrity Takes Center Stage
1.0 Abstract
Data integrity has become an important issue. To comply with regulations, companies need to optimize data integrity and...
How can Single-use Bioprocessing Technologies Tackle Current Bottlenecks?
Traditional systemic administration of chemotherapeutic agents does not differentiate between healthy and diseased tissue. Antibody-drug conjugates (ADCs) are highly...
The Challenge of cGMP in the Manufacturing of Antibody-drug Conjugates
1.0 Introduction
Antibody-drug Conjugates or ADCs are a new generation of highly hazardous / highly toxic pharmaceutical products used, among...
Big Data in Science: Which Business Model is Suitable?
1.0 Abstract
The first aim of this paper is to define which Big Data business model (in science-based activity) will...
New Learning Makes ADC Development Less Empirical
A few decades ago, the pharmaceutical industry developed and commercialized racemic small molecule drugs. Despite the success achieved with...
Utilization of Breakthrough Therapy Designations for Market Access
In the pharmaceutical marketplace, time-to-market is crucial, with companies seeking viable strategies to help hasten the review process in...
Downstream Processing Considerations for Antibody Variant Therapeutics
Abstract
Novel platforms such as antibody derivatives, peptide based therapies, gene and stem cell based therapies are gaining foothold in...
Addressing Dendritic Cells for Anticancer Immunity
By addressing the body’s own immune system the treatment of several severe diseases, e.g. infectious diseases, has become incredibly successful throughout the last centuries. Thus, it is highly desirable to adopt this concept to other diseases as well. Recently, cancer immunotherapy has become an alternative route to treat malignancies effectively without adverse side effects that are usually caused by classical cytostatics.
