Considerations for the Development of a Liquid Biopsy Assay for Cancer

HONEY REDDI | March 26, 2019 | 54 views

For a liquid biopsy test, one needs to obtain DNA from the blood that is representative of the cancer. Cells shed from a growing tumour into the blood stream; circulating tumour cells (CTCs) can be isolated and used to extract DNA for the purposes of testing. A much easier way is to isolate the DNA that is released when these cells lyse to obtain cell free DNA (cfDNA). Both CTCs and cfDNA have been demonstrated to be equally viable for a liquid biopsy assay addressing these points, which brings us to the next question of what should we be looking for as we develop the content to be evaluated?

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Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines.

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Top 10 biotech IPOs in 2019

Article | July 20, 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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MEDTECH

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

Article | July 12, 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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MEDICAL

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

Article | August 16, 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

Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines.

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INDUSTRIAL IMPACT, MEDICAL

Kymanox Announces Acquisition of Anteris Medical and Anteris Helvetia

Kymanox | February 06, 2023

Kymanox, a leading life science-focused professional services firm, recently announced the acquisition of anteris medical GmbH and anteris helvetia AG (collectively anteris). Anteris specializes in assisting the commercialization and development of medical equipment, combination and in-vitro diagnostic products. This acquisition enables both firms to achieve their common organizational goal of geographic expansion while enhancing their service capabilities by offering clients a greater range of highly specialized services. Customers who bring essential biologics, such as pharmaceuticals, cell and gene therapies (C>s) and biosimilars, medical devices, and drug/device combos to global markets will benefit significantly from the combined service offerings and office locations of the combined firms. In addition, by merging the technological, scientific, and regulatory expertise of both organizations, customers will actually benefit from this synergy to ensure FDA, EMA, Notified Bodies, and other health authorities' compliance and submission excellence. Anteris, with its offices in Holzkirchen, Germany, and Küssnacht a.R., Switzerland, offers resource-efficient and innovative solutions for end-to-end development, technical documentation, and compliance to the life science and medical device sectors. Members of Anteris' technical, quality, and regulatory teams have decades of collective expertise in combination product and device development, with a focus on biosimilar development and registration, MDR, EU, CE marking, 510(k) submissions, and quality systems regulations across all key markets. About Kymanox Founded in 2004, Kymanox is a life science professional services firm that provides scientific, engineering, project management, quality, human factors, testing/CQV, QC, and regulatory assistance to firms in the biotechnology, pharmaceutical, medical device, and combination product sectors. It assists in getting products from the bench to the patient and distinguishes itself by providing a wide variety of technical services and products as well as comprehensive project implementation. The company offers its services to clients worldwide from its headquarters in Raleigh (RTP), North Carolina, as well as offices throughout the United States.

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MEDTECH, MEDICAL

Magenta to Explore Strategic Options and Maximize Shareholder Value

Magenta Therapeutics | February 03, 2023

On February 2, 2023, Magenta Therapeutics, a clinical-stage biotech firm focused on enhancing stem cell transplantation, announced that it has completed a business evaluation, including a review of its programs, resources, and capabilities. Magenta has decided to cease further program development and conduct a complete examination of strategic alternatives aimed at maximizing shareholder value. Magenta will investigate potential strategic options, including, but not limited to, merger, an acquisition, business combination, or other transaction, as part of this review process. There can be no certainty that this review process will result in Magenta seeking a deal or that any such deal if pursued, will be completed on favorable terms. Magenta has not established a deadline for completing this review process and intends to speak further only if and when the Board of Directors has approved a clear course of action, the review process is completed, or another disclosure is considered to be appropriate. About Magenta Therapeutics Founded in 2016, Magenta Therapeutics is a clinical-stage biotechnology firm that develops therapies to help more patients with blood cancers, genetic diseases, and autoimmune diseases benefit from the curative power of stem cell transplant. Magenta is revolutionizing immunological reset for more patients by combining leadership in stem cell biology and biotherapeutics research with clinical and regulatory expertise, a new business model and vast networks in the stem cell transplant community.

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CELL AND GENE THERAPY, INDUSTRIAL IMPACT

Scientist.com Announces the Launch of Compliance Mobile App for iOS

Scientist.com | February 02, 2023

On February 1, 2023, Scientist.com, the biopharma industry's largest R&D marketplace, announced the release of a new iOS mobile app. The app provides a new, easy-to-use, on-the-go experience for purchase request approvals and compliance. In addition, iPhone users receive untethered notifications for accepting, delegating, and clarifying requests without needing to use their computers. The result is speedier approvals and fewer delays in scientific discovery. Scientist.com has spent the past fourteen years developing a digital marketplace that allows scientists to devote more time to science and less time to paperwork. The platform enables researchers to test more ideas in less time and at a lesser cost. It digitizes a company's complete research activities, automatically tracking purchases, contract management, payment processing, and generating business intelligence reports. Scientist.com Founder and CTO Chris Petersen commented, "One of the major barriers to drug discovery is the time it takes to ensure all compliance measures are met for a given research project, and understandably so." He added, "Our goal in building the Compliance Mobile App is to put compliance in the pocket of approvers, therefore minimizing the time it takes for researchers to move through the R&D process." (Source – Business Wire) Registered users of the Scientist.com platform can now get the Compliance Mobile App free from the Apple App Store About Scientist.com Founded in 2007, Scientist.com is the world's largest medical research marketplace. Its digital research platform combines a custom-built, cloud-native technology stack with a white-glove customer and scientific support, helping pharmaceutical scientists discover life-saving drugs in less time and at a lower cost. As a result, Scientist.com is accelerating and lowering the cost of medical research by connecting scientists and allowing them to exchange ideas and transact online effortlessly. The company now has a presence in enterprise marketplaces for 20 of the world's top 30 pharmaceutical firms, 80 biotechnology enterprises, and the National Institutes of Health in the United States (NIH).

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INDUSTRIAL IMPACT, MEDICAL

Kymanox Announces Acquisition of Anteris Medical and Anteris Helvetia

Kymanox | February 06, 2023

Kymanox, a leading life science-focused professional services firm, recently announced the acquisition of anteris medical GmbH and anteris helvetia AG (collectively anteris). Anteris specializes in assisting the commercialization and development of medical equipment, combination and in-vitro diagnostic products. This acquisition enables both firms to achieve their common organizational goal of geographic expansion while enhancing their service capabilities by offering clients a greater range of highly specialized services. Customers who bring essential biologics, such as pharmaceuticals, cell and gene therapies (C>s) and biosimilars, medical devices, and drug/device combos to global markets will benefit significantly from the combined service offerings and office locations of the combined firms. In addition, by merging the technological, scientific, and regulatory expertise of both organizations, customers will actually benefit from this synergy to ensure FDA, EMA, Notified Bodies, and other health authorities' compliance and submission excellence. Anteris, with its offices in Holzkirchen, Germany, and Küssnacht a.R., Switzerland, offers resource-efficient and innovative solutions for end-to-end development, technical documentation, and compliance to the life science and medical device sectors. Members of Anteris' technical, quality, and regulatory teams have decades of collective expertise in combination product and device development, with a focus on biosimilar development and registration, MDR, EU, CE marking, 510(k) submissions, and quality systems regulations across all key markets. About Kymanox Founded in 2004, Kymanox is a life science professional services firm that provides scientific, engineering, project management, quality, human factors, testing/CQV, QC, and regulatory assistance to firms in the biotechnology, pharmaceutical, medical device, and combination product sectors. It assists in getting products from the bench to the patient and distinguishes itself by providing a wide variety of technical services and products as well as comprehensive project implementation. The company offers its services to clients worldwide from its headquarters in Raleigh (RTP), North Carolina, as well as offices throughout the United States.

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MEDTECH, MEDICAL

Magenta to Explore Strategic Options and Maximize Shareholder Value

Magenta Therapeutics | February 03, 2023

On February 2, 2023, Magenta Therapeutics, a clinical-stage biotech firm focused on enhancing stem cell transplantation, announced that it has completed a business evaluation, including a review of its programs, resources, and capabilities. Magenta has decided to cease further program development and conduct a complete examination of strategic alternatives aimed at maximizing shareholder value. Magenta will investigate potential strategic options, including, but not limited to, merger, an acquisition, business combination, or other transaction, as part of this review process. There can be no certainty that this review process will result in Magenta seeking a deal or that any such deal if pursued, will be completed on favorable terms. Magenta has not established a deadline for completing this review process and intends to speak further only if and when the Board of Directors has approved a clear course of action, the review process is completed, or another disclosure is considered to be appropriate. About Magenta Therapeutics Founded in 2016, Magenta Therapeutics is a clinical-stage biotechnology firm that develops therapies to help more patients with blood cancers, genetic diseases, and autoimmune diseases benefit from the curative power of stem cell transplant. Magenta is revolutionizing immunological reset for more patients by combining leadership in stem cell biology and biotherapeutics research with clinical and regulatory expertise, a new business model and vast networks in the stem cell transplant community.

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CELL AND GENE THERAPY, INDUSTRIAL IMPACT

Scientist.com Announces the Launch of Compliance Mobile App for iOS

Scientist.com | February 02, 2023

On February 1, 2023, Scientist.com, the biopharma industry's largest R&D marketplace, announced the release of a new iOS mobile app. The app provides a new, easy-to-use, on-the-go experience for purchase request approvals and compliance. In addition, iPhone users receive untethered notifications for accepting, delegating, and clarifying requests without needing to use their computers. The result is speedier approvals and fewer delays in scientific discovery. Scientist.com has spent the past fourteen years developing a digital marketplace that allows scientists to devote more time to science and less time to paperwork. The platform enables researchers to test more ideas in less time and at a lesser cost. It digitizes a company's complete research activities, automatically tracking purchases, contract management, payment processing, and generating business intelligence reports. Scientist.com Founder and CTO Chris Petersen commented, "One of the major barriers to drug discovery is the time it takes to ensure all compliance measures are met for a given research project, and understandably so." He added, "Our goal in building the Compliance Mobile App is to put compliance in the pocket of approvers, therefore minimizing the time it takes for researchers to move through the R&D process." (Source – Business Wire) Registered users of the Scientist.com platform can now get the Compliance Mobile App free from the Apple App Store About Scientist.com Founded in 2007, Scientist.com is the world's largest medical research marketplace. Its digital research platform combines a custom-built, cloud-native technology stack with a white-glove customer and scientific support, helping pharmaceutical scientists discover life-saving drugs in less time and at a lower cost. As a result, Scientist.com is accelerating and lowering the cost of medical research by connecting scientists and allowing them to exchange ideas and transact online effortlessly. The company now has a presence in enterprise marketplaces for 20 of the world's top 30 pharmaceutical firms, 80 biotechnology enterprises, and the National Institutes of Health in the United States (NIH).

Read More

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