Emerging Therapeutics

eBook: Bispecifics — Fulfilling the Promise Through Science and Engineering

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With nine products already on the market, bispecific antibodies (bsAbs) are the most commercially advanced of all antibody-derivative biopharmaceuticals. But that isn’t to say that they face no obstacles to success. Indeed, as BPI’s senior technical editor finds in her review of recent literature and conference proceedings, the details of production and processing still confound many bsAb developers. With dozens of molecular formats in progress — and more arising all the time — the prospects for a platform process are…

Using Regulatory T Cells for Treatment of Type 1 Diabetes, Part 2: Drug Development and the Transition to Clinical Trials

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In the April 2023 issue of BPI, Leonardo Ferreira discussed the biology of type 1 diabetes and how he has worked toward developing a cure for that disease at his laboratory at the Medical University of South Carolina using chimeric antigen receptor (CAR) T regulatory cells (Tregs) (1). He spoke about industry-wide advances in developing Treg technology and how lessons learned during preclinical trials can be applied in human trials. He also discussed what the industry needs to develop Treg…

Using Regulatory T Cells for Treatment of Type 1 Diabetes, Part 1

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During the January 2023 Advanced Therapies Week in Miami, FL, Leonardo Ferreira, an assistant professor from the Medical University of South Carolina, spoke about his team’s work in developing chimeric antigen receptor (CAR) regulatory T cells (Tregs) as living therapeutics for type 1 diabetes. Ferreira has focused on type 1 diabetes since 2016, when he undertook postdoctoral work at the University of California at San Francisco under Qizhi Tang and Jeff Bluestone before continuing his research at his own laboratory…

April 20, 2023

Leveraging Material-Binding Recombinant Proteins: A Novel Approach to Tissue Regeneration

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In March 2023, I took the opportunity to speak with Luis Alvarez about the founding of Theradaptive. The company specializes in engineering recombinant proteins, with an initial focus on developing therapeutics for regeneration of soft, vascular, and bone tissue. “Theradaptive grew out of my thinking about combat injuries,” Alvarez told me. Before earning a doctoral degree in biomedical engineering from the Massachusetts Institute of Technology and working as cofounding deputy director of the US Department of Defense’s regenerative medicine program,…

April 20, 2023

Using Synthetic Biology To Develop Novel Biotherapeutics

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A multidisciplinary area of research, synthetic biology involves the use of genetic engineering to create new biological parts, devices, and systems, with potential applications in industries such as healthcare, agriculture, energy, and environmental science. As early as the 1960s, researchers combined advanced techniques in precision genetic engineering with rational drug development and explored approaches in synthetic biology to support development of innovative drug products. Later research shed new light on how molecular networks regulate cellular function and how gene expression…

December 12, 2022

Cell-Free Synthesis of Highly Potent Recombinant Neurotoxins: A Process Economic Feasibility Study

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Since its inception four decades ago, cell-free synthesis (CFS) has been used to produce biomolecules such as RNA, DNA, peptides, and proteins (1). However, most of these applications have been in early stage research and small-scale proof-of-concept studies, with rare examples of large-scale production. The slow industrial uptake of CFS has been attributed to low productivity, which suggests an uneconomical path to large-scale manufacture. Typically, a CFS platform includes a genetic template (encoding the product of interest), chemical additives (nucleotides…

December 6, 2022

Optimizing and Intensifying ADC Aggregate Removal: A DoE Approach to Membrane Chromatography and Rapid Cycling

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Antibody–drug conjugates (ADCs) represent a growing therapeutic segment of the oncology field. Five such treatments received market approval from the US Food and Drug Administration (FDA) between 2008 and 2018, whereas three were approved in 2019 and two each were approved in 2020 and 2021 (1). This disruptive technology combines highly potent small-molecule payloads with monoclonal antibodies (MAbs) to improve their specificity as cancer treatment. The antibodies deliver those toxic compounds directly to cancer cells but not to healthy cells,…

October 20, 2022

eBook: MSC-Derived Extracellular Vesicles Challenges in Production, Scale-Up, and Characterization

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The discovery of extracellular vesicles (EVs) as an intercellular communication medium has led to explorations of their therapeutic potential. EVs constitute a heterogeneous mixture of several different vesicle populations that may be similar in size but different in content, or vice versa. The vesicles can contain RNAs and proteins as well as DNAs and lipids as biological cargoes. Those cargoes can exist either intraluminally within EVs or on their surface, adding complexity to analytical considerations. EVs are classified into subpopulations…

August 29, 2022

BioProcess Insider Interview: Brian Finrow, Lumen Biosciences

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Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Brian Finrow, Co-founder & CEO, Lumen Biosciences. Although Chinese hamster ovary (CHO) cells remain the biopharmaceutical industry’s preferred expression system for antibody production, companies such as Lumen Biosciences are seeking out alternative hosts. Finrow cautioned that CHO cells sometimes complicate efforts to develop scalable and cost-effective manufacturing processes. For gastrointestinal (GI) indications such as Clostridium difficile infection and Crohn’s disease, spirulina, a biomass composed of cyanobacteria and their cellular by-products, could…

August 24, 2022

Delivering on the Promise of Bispecifics: State-of-the-Art Bispecific Antibody Development

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Bispecific antibodies (bsAbs) have transformed the field of immunotherapy. However, moving these life-changing therapeutics from the bench to the clinic can be time-consuming and costly. Further, challenges such as aggregation, degradation, fragmentation, and denaturation may ultimately hinder a program from advancing to the clinic. Partnering with a CDMO with relevant experience and technologies can be critical for safely and cost-effectively manufacturing bispecific antibodies. With Selexis’s cell line technology and KBI Biopharma’s manufacturing and analytics, we lead the industry in technologies…

June 22, 2022