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Podcast: Industry veteran moves to Lykan Bioscience, and this time its personal!

In the latest episode of the BioProcess Insider Expression Platform, we explore the evolution of cell and gene therapy production with new COO of Lykan Bioscience, Patrick Lucy. From Repligen, to Lonza, to Pfenex, Patrick Lucy has had an illustrious career. His latest career move is to Lykan Bioscience, a Massachusetts-based contract Manufacturing Services Organization (MSO) and provider of end-to-end solution for cell-based therapies, where he took on the role of chief operating officer (COO) in January. In this podcast,…

eBook: Biomarkers — Improving Clinical Studies to Enhance Commercial Success for Biologics

The biopharmaceutical industry continues to invest heavily in technologies for identification of predictive biomarkers. Drug developers want not only to find quantitative evidence that their therapies will work as designed, but also to anticipate which patient populations will respond positively to those regimens. Doing that could streamline clinical trials, accelerate approvals, and ultimately improve patient outcomes. Advances in next-generation sequencing and increases in computational capability now are facilitating biomarker inquiries, especially in the realm of immunooncology. However, predictive biomarkers remain…

Manufacture and Regulation of Cell, Gene, and Tissue Therapies, Part 1: Chemistry, Manufacturing, and Control Challenges

Cell, gene, and tissue (CGT) therapies and other advanced-therapy medicinal products (ATMPs) have made tremendous progress over the past decade. They are different from other biologics and small molecules because of their inherent complexity and variability. Although many unknowns remain about the development of these products, their clinical success has enabled the CGT therapy and ATMP fields to advance rapidly. We are seeing an increase in the number of marketing authorization applications (MAAs) filed in the European Union and new…

Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 2: Process Modeling and Analytics

Part 1 of this article focused on the first two sessions of a CASSS chemistry, manufacturing, and controls (CMC) forum entitled “Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies,” which took place on 16–17 July 2018 in Gaithersburg, MD. Those sessions focused on upstream and downstream process technologies and strategies (1). Part 2 highlights the final two conference sessions on process modeling, control, and analytics. Process Modeling and Control The third conference session was “Modeling and Control Strategies.” Advancements in…

Innovations in the Manufacturing of Cell and Gene Therapies

Advancements in next-generation cell and gene therapies are fulfilling the promise of personalized medicine and attempting to cure and heal patients. Multiple approved products have been launched in global markets and the number of clinical trials continues to grow. Developing innovative advanced therapies is one of the biopharmaceutical industry’s greatest opportunities to dramatically improve patients’ lives. WuXi Advanced Therapies is a contract testing, development, and manufacturing organization (CTDMO) that has launched several innovative world-class platforms. It offers integrated platforms to…

Drug Formulations Are Changing:
New Sterile Filtration Challenges in the Changing Landscape of Drug Formulations

Read about the challenges of sterile filtration of high concentration mAbs, liposomes, and lentiviral vectors, and how to solve them in this Special Report. Development of new, complex drug formulations has given us therapeutics with properties that are markedly different from traditional drug types. High viscosity or low surface tension formulations or large viral vector molecules can mean that sterile filtration processes, which are optimized for traditional drug types, are not as efficient for the new, complex formulations. Premature filter…

G-Protein–Coupled Receptors: Promising Targets for Antibody–Drug Conjugates

G-protein–coupled receptors (GPCRs) are a large and diverse family of seven-transmembrane–domain proteins expressed on the surface of human cells. These molecules respond to external stimuli by initiating signal-transduction pathways that affect the expression of a large family of genes — which, in turn, regulate a range of vital physiological processes and functions. Figure 1 illustrates the general pathways of GPCRs. Without these proteins, humans simply could not survive: Without β-adrenergic receptors, we could not regulate our blood sugar, for example;…

From Target to Hit: The WuXi HitS Platform

Alex Satz, senior director, DEL strategy and operations, WuXi AppTec Satz talked about WuXi AppTec’s launch of the HitS (Hit Success) business unit, designed to serve client needs in early stage drug discovery. WuXi’s goals are to provide more and higher-quality hit molecules against targets of interest and to help set the stage for follow-up medical-chemistry optimization. The unit works with all protein target classes, including solubilized membrane proteins and challenging protein complexes. A core strength of the HitS business…