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Successful Strategies in the Development and Technology Transfer of...
Abstract: Effective introduction of a monoclonal antibody or antibody-drug conjugate into clinical trials and final commercialization requires a defined path toward an efficient, robust manufacturing...
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Challenges and Strategies for the Downstream Processing of BiSpecific...
Abstract The overall trend in the biotherapeutics arena includes transitioning towards molecules that have higher value, potency, and thus smaller production volumes. Antibody Drug Conjugates (ADCs)...
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The Clinical Landscape of Antibody-drug Conjugates
Abstract Introduction: Antibody drug conjugates (ADCs) are a class of therapeutics that combine the selective targeting properties of monoclonal antibodies (mAbs) with potent cell killing activities of...
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Addressing Dendritic Cells for Anticancer Immunity
1.0 Commentary 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...
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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 the market for several reasons, including the need for better...
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Editorial: 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 the United States. Manufacturers must meet the requirements...
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Editorial: 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 racemic drugs, the risk associated with the use of an...
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Big Data in Science: Which Business Model is Suitable?
1.o Abstract The first aim of this paper is to define which Big Data business model (in science-based activity) will be able to provide IT services to biotechnology and life sciences companies, as well...
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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 other things, in the targeted treatment of cancer. Most of...
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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 the underlying strategies involved in compliance and accountability....
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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 are crucial in gaining a better...
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Drugs and Drug Hunters
All products of the creative process are a reflection of the individual makeup of the inventors. A painting by Mark Rothko looks like a Rothko painting. A symphony by Wolfgang Amadeus Mozart does not...
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Antibody-Drug Conjugates: Manufacturing Challenges and Trends
Antibody-drug conjugates (ADCs), a form of Immuno-conjugate or bio-conjugate, are an emerging class of medicines designed for high-specificity targeting and destruction of cancer cells. The mechanism...
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Trial of High Efficiency TFF Capsule Prototype for ADC Purification
Antibody-drug conjugates (ADCs) are an emerging class of highly targeted cancer therapies in which a monoclonal antibody is chemically conjugated to a cytotoxic drug (payload). These complex...
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Environmental Risk Assessment and New Drug Development
1.0 Abstract In our globalized world, human pharmaceutical residues and traces of other (chemical) down-the-drain contaminants have become an environmental concern. Following the detection of...
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Challenges in Environmental Testing of Multi-component Substances
1.0 Abstract An Environmental Risk Assessment or ERA needs to clearly identify hazard and exposure to evaluate risk. Having good analytical chemistry methods is essential in measuring environmental...
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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 the market for several reasons, including the need for better...
View ArticleClik here to view.
Editorial: 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 the United States. Manufacturers must meet the requirements...
View ArticleClik here to view.
Challenges in Environmental Testing of Multi-component Substances
1.0 Abstract An Environmental Risk Assessment or ERA needs to clearly identify hazard and exposure to evaluate risk. Having good analytical chemistry methods is essential in measuring environmental...
View ArticleClik here to view.
Environmental Risk Assessment and New Drug Development
1.0 Abstract In our globalized world, human pharmaceutical residues and traces of other (chemical) down-the-drain contaminants have become an environmental concern. Following the detection of...
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