Building Bioprocessing from Data

MIKE MAY | November 20, 2019 | 172 views

First and foremost, by developing your bioprocess with a focus on collecting and analyzing all of the data attendant to that process, you can go back and audit what you’ve done in a high resolution manner. You should also realize that the data is going to include some very subtle and nuanced things. In manufacturing a cell product, for instance, you’re going to want to dive deep into the starting material analytics—everything from genomics to transcriptomics and secretomics, etc. If you generate this huge dataset and then analyze it, you’ll be able to figure out what subtle differences between, for example, the starting material genome or the starting material transcriptome actually impacts and influences what you get in the end product.

Spotlight

MetaStar, Inc.

MetaStar is a quality improvement organization with 45 years of experience working alongside those in the health care system to improve the quality of health care for all patients. Our health care improvement and consulting services address the need for system-wide innovation and consistent, evidence-based approaches across all settings of care. All of our work is guided by our mission, to effect positive change in health and health care. We work with communities, providers, and insurers to transform care with a vision of optimal health for all. MetaStar is an independent nonprofit based in Madison and represents Wisconsin in the Lake Superior Quality Innovation Network.

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Medical

Top 10 biotech IPOs in 2019

Article | July 14, 2022

The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Here’s the long answer: In the words of Renaissance Capital, the IPO market had “a mostly good year.” The total number of deals fell to 159 from 192 the year before, but technology and healthcare companies were standout performers. The latter—which include biotech, medtech and diagnostics companies—led the pack, making up 43% of all IPOs in 2019. By Renaissance’s count, seven companies went public at valuations exceeding $1 billion, up from five the year before

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Medical

Cell Out? Lysate-Based Expression an Option for Personalized Meds

Article | August 16, 2022

Cell-free expression (CFE) is the practice of making a protein without using a living cell. In contrast with cell line-based methods, production is achieved using a fluid containing biological components extracted from a cell, i.e., a lysate. CFE offers potential advantages for biopharma according to Philip Probert, PhD, a senior scientist at the Centre for Process Innovation in the U.K.

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Research

Closing bacterial genomes from the human gut microbiome using long-read sequencing

Article | July 11, 2022

In our lab, we focus on the impact of the gut microbiome on human health and disease. To evaluate this relationship, it’s important to understand the particular functions that different bacteria have. As bacteria are able to exchange, duplicate, and rearrange their genes in ways that directly affect their phenotypes, complete bacterial genomes assembled directly from human samples are essential to understand the strain variation and potential functions of the bacteria we host. Advances in the microbiome space have allowed for the de novo assembly of microbial genomes directly from metagenomes via short-read sequencing, assembly of reads into contigs, and binning of contigs into putative genome drafts. This is advantageous because it allows us to discover microbes without culturing them, directly from human samples and without reference databases. In the past year, there have been a number of tour de force efforts to broadly characterize the human gut microbiota through the creation of such metagenome-assembled genomes (MAGs)[1–4]. These works have produced hundreds of thousands of microbial genomes that vastly increase our understanding of the human gut. However, challenges in the assembly of short reads has limited our ability to correctly assemble repeated genomic elements and place them into genomic context. Thus, existing MAGs are often fragmented and do not include mobile genetic elements, 16S rRNA sequences, and other elements that are repeated or have high identity within and across bacterial genomes.

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Selexis Cell Line Development Strategies

Article | February 11, 2020

In today’s biotechnology landscape, to be competitive, meet regulations, and achieve market demands, “we must apply Bioprocessing 4.0,” said Igor Fisch, PhD, CEO, Selexis. In fact, in the last decade, “Selexis has evolved from cloning by limiting dilution to automated cell selection to nanofluidic chips and from monoclonality assessment by statistical calculation to proprietary bioinformatic analysis,” he added. Single-use processing systems are an expanding part of the biomanufacturing world; as such, they are a major component of Bioprocessing 4.0. “At Selexis, we use single use throughout our cell line development workflow. Currently, we have incorporated single-use automated bioprocessing systems such as ambr® and the Beacon® optofluidic platform for accelerated cell line development. By using these systems and optimizing our parameters, we were able to achieve high titers in shake flasks. Additionally, the Beacon systems integrate miniaturized cell culture with high-throughput liquid handling automation and cell imaging. This allows us to control, adjust, and monitor programs at the same time,” noted Fisch.

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Spotlight

MetaStar, Inc.

MetaStar is a quality improvement organization with 45 years of experience working alongside those in the health care system to improve the quality of health care for all patients. Our health care improvement and consulting services address the need for system-wide innovation and consistent, evidence-based approaches across all settings of care. All of our work is guided by our mission, to effect positive change in health and health care. We work with communities, providers, and insurers to transform care with a vision of optimal health for all. MetaStar is an independent nonprofit based in Madison and represents Wisconsin in the Lake Superior Quality Innovation Network.

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Advances in Cell Culture Media Formulation and Development

Genengnews | July 10, 2019

For decades commercial and academic scientists have sought reliable serum-free media. As far back as the 1960s a number of options were available for the cultivation of some cell lines. Now, after years of effort, many of the shortcomings of these early formulations have been resolved, and researchers have a number of highly successful alternatives available. For CHO bioproduction in a fed-batch process, there are two media and feed systems that we recommend. The first, the EX-CELL. Advanced CHO Fed Batch System, is optimized for fed-batch processes. The second, Cellvento. 4CHO medium and 4Feed, are unique in that the feed contains a modified form of tyrosine, which allows high concentrations of this amino acid at neutral pH. Both systems contain only chemically defined components and are animal- component free. These two media systems display high titers, protein quality, and scalability when operating in a fed-batch mode. However, if the bioproduction process is perfusion, then the nutritional needs of the cell line will be different and a medium optimized for that mode of production is essential.

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Cobra Biologics and Symbiosis Complete Viral Vector Collaboration

Genengnews | July 10, 2019

Cobra Biologics, a CDMO focused on viral vector drug substance production, and Symbiosis Pharmaceutical Services, a CMO specializing in the sterile manufacture of injectable viral vector drug products, reported the successful completion of their collaboration to develop synergistic capabilities. Intended to accelerate the clinical and commercial production of viral vectors, which represent part of the burgeoning Advanced Therapeutics Medicinal Product (ATMP) drug development space and the growth of personalized medicine, the 18-month joint project saw a combined investment of £4.8m including significant support from a grant received under the U.K. government’s Innovate UK Health and Life Sciences Program. The collaboration significantly increases both companies’ existing commercial capacity and simplifies the supply chain process for the manufacture of viral vectors for use in gene therapy and immunotherapy, said Peter Coleman, CEO of Cobra. By aligning the technical expertise and manufacturing capabilities of Cobra and Symbiosis, the complexity, time, and risk of viral vector manufacturing projects will be greatly reduced meaning that customer companies developing viral vector ATMPs can derive their own competitive value from accelerating their progression along the drug development critical path, he added.

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Advances in Cell Culture Media Formulation and Development

Genengnews | July 10, 2019

For decades commercial and academic scientists have sought reliable serum-free media. As far back as the 1960s a number of options were available for the cultivation of some cell lines. Now, after years of effort, many of the shortcomings of these early formulations have been resolved, and researchers have a number of highly successful alternatives available. For CHO bioproduction in a fed-batch process, there are two media and feed systems that we recommend. The first, the EX-CELL. Advanced CHO Fed Batch System, is optimized for fed-batch processes. The second, Cellvento. 4CHO medium and 4Feed, are unique in that the feed contains a modified form of tyrosine, which allows high concentrations of this amino acid at neutral pH. Both systems contain only chemically defined components and are animal- component free. These two media systems display high titers, protein quality, and scalability when operating in a fed-batch mode. However, if the bioproduction process is perfusion, then the nutritional needs of the cell line will be different and a medium optimized for that mode of production is essential.

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Cobra Biologics and Symbiosis Complete Viral Vector Collaboration

Genengnews | July 10, 2019

Cobra Biologics, a CDMO focused on viral vector drug substance production, and Symbiosis Pharmaceutical Services, a CMO specializing in the sterile manufacture of injectable viral vector drug products, reported the successful completion of their collaboration to develop synergistic capabilities. Intended to accelerate the clinical and commercial production of viral vectors, which represent part of the burgeoning Advanced Therapeutics Medicinal Product (ATMP) drug development space and the growth of personalized medicine, the 18-month joint project saw a combined investment of £4.8m including significant support from a grant received under the U.K. government’s Innovate UK Health and Life Sciences Program. The collaboration significantly increases both companies’ existing commercial capacity and simplifies the supply chain process for the manufacture of viral vectors for use in gene therapy and immunotherapy, said Peter Coleman, CEO of Cobra. By aligning the technical expertise and manufacturing capabilities of Cobra and Symbiosis, the complexity, time, and risk of viral vector manufacturing projects will be greatly reduced meaning that customer companies developing viral vector ATMPs can derive their own competitive value from accelerating their progression along the drug development critical path, he added.

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