Setting New Standards for CRO/CDMO Industry

Traditionally, U.S. life sciences contract organizations have focused on either research (CRO) or development and manufacturing (CDMO). Founded in 2009, LakePharma is defying tradition and has evolved into the first U.S.-based, full-scale CRDMO to provide an integrated suite of end-to-end services for the biologics development community.

Spotlight

MacroGenics, Inc.

MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases. MacroGenics creates both differentiated molecules that are directed to novel cancer targets, as well as “bio-betters,” which are drugs designed to improve upon marketed medicines.

OTHER ARTICLES
Medical

2 Small-Cap Biotech Stocks You Haven't Heard of, But Should Know About

Article | July 14, 2022

With everything that's going on with the COVID-19 pandemic, many healthcare companies have grabbed plenty of spotlight during these challenging times. At the same time, a number of otherwise promising businesses have slipped under the radar. That's especially true for small-cap biotech stocks that aren't actively involved in developing tests, vaccines or treatments for COVID-19. Vaccine developers, protective equipment producers, and healthcare service providers are all attracting plenty of attention during this pandemic, but there are just as many promising biotech stocks that aren't involved in these areas. Here are two such companies that you might have missed, but they deserve a spot on your watch list.

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MedTech

Making Predictions by Digitizing Bioprocessing

Article | July 11, 2022

With advances in data analytics and machine learning, the move from descriptive and diagnostic analytics to predictive and prescriptive analytics and controls—allowing us to better forecast and understand what will happen and thus optimize process outcomes—is not only feasible but inevitable, according to Bonnie Shum, principal engineer, pharma technical innovation, technology & manufacturing sciences and technology at Genentech. “Well-trained artificial intelligence systems can help drive better decision making and how data is analyzed from drug discovery to process development and to manufacturing processes,” she says. Those advances, though, only really matter when they improve the lives of patients. That’s exactly what Shum expects. “The convergence of digital transformation and operational/processing changes will be critical for the facilities of the future and meeting the needs of our patients,” she continues. “Digital solutions may one day provide fully automated bioprocessing, eliminating manual intervention and enabling us to anticipate potential process deviations to prevent process failures, leading to real-time release and thus faster access for patients.” To turn Bioprocessing 4.0 into a production line for precision healthcare, real-time release and quickly manufacturing personalized medicines will be critical. Adding digitization and advanced analytics wherever possible will drive those improvements. In fact, many of these improvements, especially moving from descriptive to predictive bioprocessing, depend on more digitization.

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MedTech

Data Analytics: A Groundbreaking Technology in Biotech

Article | September 22, 2022

Biotechnology is a vast discipline of biology that employs diverse biological systems to create solutions that can significantly alter the ways in which they operate across various domains. That said, biotechnology is not a new notion. It has existed for millennia, with ancient civilizations using its earliest incarnations to cultivate crops and create alcoholic beverages. Today, the biotechnology industry has developed by leaps and bounds and has amassed a vast quantity of scientific data through study and research. Given the importance of data in the biotechnology business, it is not difficult to understand why biotech companies utilize data analytics. Modern data analytics tools have made it possible for researchers in the biotech industry to build predictive analytics models and gain knowledge about the most efficient approaches to accomplish their desired goals and objectives. Data analytics is increasingly being adopted by biotech businesses to better understand their industry and foresee any problems down the road. How is Data Analytics Revolutionizing Fields in Biotechnology? Today's business and scientific fields greatly benefit from data. Without the analysis of vast information libraries that provide new insights and enable new innovations, no industry can really advance. Being highly reliant on big data analytics, biotech is not an exception in this regard. With the tools and methods that help scientists systematize their findings and speed up their research for better and safer results, data analytics is making deeper inroads into the biotechnology industry. It is emerging as a crucial link between knowledge and information and is extensively being used for purposes other than just examining the information that is already available. The following are a few of the cutting-edge biotechnology applications of data analytics Genomics and Disease Treatment Pharmaceutical Drug Discovery Drug Recycling and Safety Agriculture and Agri-products Environmental Damage Mitigation Data Analytics Possibilities in Biotechnology With data analytics becoming an integral part of how biotech businesses operate, biotechnologists and related stakeholders need to understand its emergence and crucial role. Data analytics has opened new frontiers in the realm of biotechnology. Thanks to developments in data analytics, research and development activities that once took years may now be accomplished in a matter of months. Also, now scientists have access to biological, social, and environmental insights that can be exploited to create more effective and sustainable products. By understanding the importance of data-related tools and techniques applications, biotech companies are aiming to invest in the popularizing technology to stay updated in the fast-paced biotechnology industry.

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Medical

Advancement in Genomics Accelerating its Penetration into Precision Health

Article | June 22, 2022

Genomics is an interdisciplinary field of biology emphasizing the structure, editing, evolution, function, and mapping of genomes. It is creating deeper inroads across the precision health domain with the increasing introduction of advanced technologies such as quantum simulation, next-generation sequencing (NGS), and precise genome manipulation. As precision health focuses on providing the proper intervention to the right patient at the right time, genomics increasingly finds applications in human and pathogen genome sequencing in clinical and research spaces. Rising Hereditary Diseases Burden Paving the Way for Genomics in Precision Health In the last few years, a significant surge in the prevalence of diseases and ailments such as diabetes, obesity, baldness, and others has been witnessed across the globe. A history of family members with chronic diseases, such as cancer, diabetes, high blood pressure, hearing issues, and heart disease, can sometimes continue into the next generation. Hence, the study of genes is extensively being conducted for predicting health risks and early treatment of these diseases. It also finds use in CRISPR-based diagnostics and the preparation of precision medication for the individual. In addition, ongoing advancements in genomics are making it possible to identify different genetic traits that persuade people to more widespread diseases and health problems. The Emergence of Genomics Improves Disease Understanding Genomics refers to the study of the complete genetic makeup of a cell or organism. Increasing scientific research in the area substantially contributes to increasing knowledge about the human genome and assists in improving the ability to understand disease etiology, risk, diagnosis, treatment, and prevention. On account of these improvements, innovative genomic technologies and tools are being developed to enable better precision health not only for the individual but for various regional populations as well. The Way Forward With growing preference for personalized medicine and an increasing need for more accurate pathogen detection and diagnostics, genomics is gaining huge popularity across the precision health domain. Also, increasing research activities for developing novel high-precision therapeutics and rising importance of gene study in the prevention, diagnosis, and management of infectious and genetic diseases will further pave the way for genomics in the forthcoming years.

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Spotlight

MacroGenics, Inc.

MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases. MacroGenics creates both differentiated molecules that are directed to novel cancer targets, as well as “bio-betters,” which are drugs designed to improve upon marketed medicines.

Related News

Cell and Gene Therapy, Diagnostics

NorthX Biologics, a leading Nordic development and manufacturing organisation announces acquisition of a biologics manufacturing unit from Valneva

Globenewswire | July 04, 2023

NorthX Biologics (‘NorthX’), a leading Nordic development and manufacturing organisation with a focus on advanced biologics, CGT (cell and gene therapy) and vaccines, announced today the successful acquisition of the Stockholm-based Clinical Trial Manufacturing unit from Valneva Sweden, significantly expanding capabilities. The acquisition includes the transfer of a multi-purpose facility, situated in the Stockholm life science cluster, close to Karolinska University Hospital. In addition, 30 staff members who currently operate the facility will also join NorthX. The site and staff have a long history with extensive experience of serving both Valneva internally and also working with external customers on a contract development and manufacturing basis. With expertise in mammalian expression systems and viral vectors, the capabilities complement those of NorthX’s existing business of advanced microbial based manufacturing of proteins and plasmid DNA. The acquired unit excels in process development, scale up, GMP production, quality control analytics, and quality assurance/release and is capable of working with Biosafety Level (BSL) 2/2+ and BSL 3 organisms. With this expansion, NorthX enhances its capabilities and can offer comprehensive services to a wider range of clients globally. Janet Hoogstraate, currently Managing Director of Valneva Sweden, will join the NorthX team. She commented, “I am very proud when looking back at what we have achieved within the unit over the past years and look forward with great enthusiasm to build on NorthX’s position as the go-to manufacturer of advanced biologics in Northern Europe.” Helena Strigård, CEO of NorthX, said, “We are delighted to join forces with our new colleagues in Stockholm to bring new innovative treatments to tomorrow’s patients.” Thomas Eldered, Chairman of NorthX, commented, “This strategic move marks a significant milestone in our growth journey and strengthens NorthX as Sweden’s Innovation Hub. We are now able to work with ATMPs and advanced biologics, including process development and manufacture for clinical trials and commercial requirements.” ABOUT NORTHX BIOLOGICS NorthX Biologics develops and manufactures advanced biologics and has over 30 years of GMP production experience. The team provides process development and GMP manufacturing services with expertise in plasmid DNA, mRNA, proteins, cell therapy and other advanced biologics. Headquartered in the heart of Sweden, the team serves customers worldwide. In 2021 NorthX was recognised and appointed as the national innovation hub for GMP manufacture of advanced therapeutics and vaccines by the Swedish Government and Vinnova, Sweden's innovation agency. NorthX has the ambition to become a leading cell and gene therapy manufacturer and partner of choice for innovative drug development companies. For more information visit www.nxbio.com.

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Medical

Pfizer and BioNTech Begin Rolling Submission of Biologics License Application for FDA Approval of COVID-19 Vaccine in the U.S

Pfizer, BioNTech | May 10, 2021

Pfizer Inc. and BioNTech SE confirmed today the filing of a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in people aged 16 and above. Companies will send data to help the BLA to the FDA on a rolling basis in the coming weeks, along with a proposal for Priority Review. If the BLA has been completed and duly approved for review by the FDA, the FDA will set a target date for a determination under the Prescription Drug User Fee Act (PDUFA). The Pfizer-BioNTech COVID-19 Vaccine is now available in the United States under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) on December 11, 2020. Since then, the firms have distributed more than 170 million doses of the vaccine in the United States. The next step in the comprehensive FDA evaluation process is the submission of a BLA, which includes longer-term follow-up data for acceptance and approval. Pfizer and BioNTech started the BLA process by providing the nonclinical and clinical data needed to justify the licensure of the COVID-19 vaccine for use in people aged 16 and up. This covers the most recent analyses from the pivotal Phase 3 clinical trial, in which the vaccine's effectiveness and safety profile were detected up to six months after the second dose. In the coming weeks, the companies will submit the required manufacturing and facility details for licensure, completing the BLA. Pfizer and BioNTech have since submitted to expand the new EUA for their COVID-19 vaccine to cover individuals aged 12 to 15. The firms plan to send a supplemental BLA to facilitate vaccine licensure in this age group until the requisite data is available six months after the second vaccine dose. BioNTech and Pfizer collaborated to create the Pfizer-BioNTech COVID-19 Vaccine, which is built on BioNTech's patented mRNA technology. BioNTech is the European Union's Marketing License Holder, as well as the holder of emergency use authorizations or similar in the United States (along with Pfizer), the United Kingdom, Canada, and other countries in advance of a planned application for full marketing authorizations in these countries. The Pfizer-BioNTech COVID-19 Vaccine has not been authorized or licensed by the United States Food and Drug Administration (FDA), but it has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in people aged 16 and up. The emergency use of this product is only permitted for the duration of the declaration the circumstances justify the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act until the declaration is terminated or the authorization is revoked sooner. About Pfizer At Pfizer, they utilize science and its global resources to deliver treatments to patients that significantly extend and change their lives. In the discovery, development, and manufacture of health care products, including innovative medicines and vaccines, they aim to set the benchmark for consistency, safety, and value. Every day, Pfizer colleagues collaborate in developing and emerging markets to advance wellness, prevention, treatments, and remedies for today's most feared diseases. As one of the world's leading innovative biopharmaceutical firms, they partner with health care providers, governments, and local communities to promote and improve access to reliable and affordable health care around the world. About BioNTech Biopharmaceutical New Technologies is a next-generation immunotherapy firm that is developing novel cancer and other severe disease therapies. For the accelerated production of new biopharmaceuticals, the company makes use of a diverse set of computational discovery and therapeutic drug platforms. Its oncology product candidates include individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies, and small molecules from Fosun Pharma and Pfizer.

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Cell and Gene Therapy

Y-Biologics and Pierre Fabre Announces Strategic Partnership in the Field of Immuno-Oncology Research

Y-Biologics | November 23, 2020

The South Korean biotech organization Y-Biologics and the French pharmaceutical group Pierre Fabre have declared their arrangements to frame a key association in the field of immuno-oncology research. The choice has been recognized through a letter of aim endorsed by the two players and will be affirmed in the coming a very long time through an itemized arrangement. The joint effort is set to run for a very long time, with the chance of a two-year expansion. Y-Biologics, which spends significant time in the revelation of monoclonal antibodies, and the Pierre Fabre gathering, France's second-biggest private drug lab, plan to join their subject matters with the point of recognizing and creating novel restorative monoclonal antibodies focusing on key immunosuppressive mechanisms activated within solid tumors.

Read More

Cell and Gene Therapy, Diagnostics

NorthX Biologics, a leading Nordic development and manufacturing organisation announces acquisition of a biologics manufacturing unit from Valneva

Globenewswire | July 04, 2023

NorthX Biologics (‘NorthX’), a leading Nordic development and manufacturing organisation with a focus on advanced biologics, CGT (cell and gene therapy) and vaccines, announced today the successful acquisition of the Stockholm-based Clinical Trial Manufacturing unit from Valneva Sweden, significantly expanding capabilities. The acquisition includes the transfer of a multi-purpose facility, situated in the Stockholm life science cluster, close to Karolinska University Hospital. In addition, 30 staff members who currently operate the facility will also join NorthX. The site and staff have a long history with extensive experience of serving both Valneva internally and also working with external customers on a contract development and manufacturing basis. With expertise in mammalian expression systems and viral vectors, the capabilities complement those of NorthX’s existing business of advanced microbial based manufacturing of proteins and plasmid DNA. The acquired unit excels in process development, scale up, GMP production, quality control analytics, and quality assurance/release and is capable of working with Biosafety Level (BSL) 2/2+ and BSL 3 organisms. With this expansion, NorthX enhances its capabilities and can offer comprehensive services to a wider range of clients globally. Janet Hoogstraate, currently Managing Director of Valneva Sweden, will join the NorthX team. She commented, “I am very proud when looking back at what we have achieved within the unit over the past years and look forward with great enthusiasm to build on NorthX’s position as the go-to manufacturer of advanced biologics in Northern Europe.” Helena Strigård, CEO of NorthX, said, “We are delighted to join forces with our new colleagues in Stockholm to bring new innovative treatments to tomorrow’s patients.” Thomas Eldered, Chairman of NorthX, commented, “This strategic move marks a significant milestone in our growth journey and strengthens NorthX as Sweden’s Innovation Hub. We are now able to work with ATMPs and advanced biologics, including process development and manufacture for clinical trials and commercial requirements.” ABOUT NORTHX BIOLOGICS NorthX Biologics develops and manufactures advanced biologics and has over 30 years of GMP production experience. The team provides process development and GMP manufacturing services with expertise in plasmid DNA, mRNA, proteins, cell therapy and other advanced biologics. Headquartered in the heart of Sweden, the team serves customers worldwide. In 2021 NorthX was recognised and appointed as the national innovation hub for GMP manufacture of advanced therapeutics and vaccines by the Swedish Government and Vinnova, Sweden's innovation agency. NorthX has the ambition to become a leading cell and gene therapy manufacturer and partner of choice for innovative drug development companies. For more information visit www.nxbio.com.

Read More

Medical

Pfizer and BioNTech Begin Rolling Submission of Biologics License Application for FDA Approval of COVID-19 Vaccine in the U.S

Pfizer, BioNTech | May 10, 2021

Pfizer Inc. and BioNTech SE confirmed today the filing of a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in people aged 16 and above. Companies will send data to help the BLA to the FDA on a rolling basis in the coming weeks, along with a proposal for Priority Review. If the BLA has been completed and duly approved for review by the FDA, the FDA will set a target date for a determination under the Prescription Drug User Fee Act (PDUFA). The Pfizer-BioNTech COVID-19 Vaccine is now available in the United States under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) on December 11, 2020. Since then, the firms have distributed more than 170 million doses of the vaccine in the United States. The next step in the comprehensive FDA evaluation process is the submission of a BLA, which includes longer-term follow-up data for acceptance and approval. Pfizer and BioNTech started the BLA process by providing the nonclinical and clinical data needed to justify the licensure of the COVID-19 vaccine for use in people aged 16 and up. This covers the most recent analyses from the pivotal Phase 3 clinical trial, in which the vaccine's effectiveness and safety profile were detected up to six months after the second dose. In the coming weeks, the companies will submit the required manufacturing and facility details for licensure, completing the BLA. Pfizer and BioNTech have since submitted to expand the new EUA for their COVID-19 vaccine to cover individuals aged 12 to 15. The firms plan to send a supplemental BLA to facilitate vaccine licensure in this age group until the requisite data is available six months after the second vaccine dose. BioNTech and Pfizer collaborated to create the Pfizer-BioNTech COVID-19 Vaccine, which is built on BioNTech's patented mRNA technology. BioNTech is the European Union's Marketing License Holder, as well as the holder of emergency use authorizations or similar in the United States (along with Pfizer), the United Kingdom, Canada, and other countries in advance of a planned application for full marketing authorizations in these countries. The Pfizer-BioNTech COVID-19 Vaccine has not been authorized or licensed by the United States Food and Drug Administration (FDA), but it has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in people aged 16 and up. The emergency use of this product is only permitted for the duration of the declaration the circumstances justify the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act until the declaration is terminated or the authorization is revoked sooner. About Pfizer At Pfizer, they utilize science and its global resources to deliver treatments to patients that significantly extend and change their lives. In the discovery, development, and manufacture of health care products, including innovative medicines and vaccines, they aim to set the benchmark for consistency, safety, and value. Every day, Pfizer colleagues collaborate in developing and emerging markets to advance wellness, prevention, treatments, and remedies for today's most feared diseases. As one of the world's leading innovative biopharmaceutical firms, they partner with health care providers, governments, and local communities to promote and improve access to reliable and affordable health care around the world. About BioNTech Biopharmaceutical New Technologies is a next-generation immunotherapy firm that is developing novel cancer and other severe disease therapies. For the accelerated production of new biopharmaceuticals, the company makes use of a diverse set of computational discovery and therapeutic drug platforms. Its oncology product candidates include individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies, and small molecules from Fosun Pharma and Pfizer.

Read More

Cell and Gene Therapy

Y-Biologics and Pierre Fabre Announces Strategic Partnership in the Field of Immuno-Oncology Research

Y-Biologics | November 23, 2020

The South Korean biotech organization Y-Biologics and the French pharmaceutical group Pierre Fabre have declared their arrangements to frame a key association in the field of immuno-oncology research. The choice has been recognized through a letter of aim endorsed by the two players and will be affirmed in the coming a very long time through an itemized arrangement. The joint effort is set to run for a very long time, with the chance of a two-year expansion. Y-Biologics, which spends significant time in the revelation of monoclonal antibodies, and the Pierre Fabre gathering, France's second-biggest private drug lab, plan to join their subject matters with the point of recognizing and creating novel restorative monoclonal antibodies focusing on key immunosuppressive mechanisms activated within solid tumors.

Read More

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