Pharmaceutical & Biotechnology Environmental Monitoring Market Huge Growth Opportunity by 2022 via These Industry Trends Report

windstreetz.com | December 06, 2019

The ongoing report on Pharmaceutical & Biotechnology Environmental Monitoring Market-Global Industry Analysis and Forecast to 2022 refreshed by Alexa Reports offers a wide viewpoint of current patterns controlling over the worldwide market. The report highlights information review by key players’ profiles, and their advancements in the field. Our exploration examiners have utilized approved information and essential research sources to give the market inquired report. The report publicizes players, their systems and proposes result-sorted out methods to extend a compelling edge in the Pharmaceutical & Biotechnology Environmental Monitoring market.The target of Pharmaceutical & Biotechnology Environmental Monitoring reports is to framework, fragment, and task the market on the possibility of item types, application, and locale, and to explain the variables concerning the elements affecting worldwide Pharmaceutical & Biotechnology Environmental Monitoring market elements, approaches, financial matters, and innovation and so forth.

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Find out more about scientific outreach the Biotechnology & Bioengineering Center conducts in Milwaukee-area schools

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Find out more about scientific outreach the Biotechnology & Bioengineering Center conducts in Milwaukee-area schools

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MEDICAL

Peptilogics Announces FDA Clearance of Investigational New Drug Application to Initiate Clinical Trial of PLG0206 in Periprosthetic Joint Infection

Peptilogics | January 11, 2022

Peptilogics, a biotech company that engineers peptide therapeutics to radically improve the treatment landscape for patients with life-threatening diseases, announced that the U.S. Food and Drug Administration as accepted the company's Investigational New Drug Application for PLG0206 to treat periprosthetic joint infection allowing the Phase 1b study to proceed. Peptilogics will evaluate the safety and efficacy of PLG0206 in a Phase 1b open-label, dose-escalating study in patients undergoing debridement, antibiotics and implant retention surgery for the treatment of PJI occurring after total knee arthroplasty. “PJI is a devastating condition with limited treatment options, since systemic antibiotics frequently fail to eliminate the infection and surgery to remove the infected hardware is then required. Based on our promising preclinical efficacy and healthy volunteer Phase 1 study data with PLG0206, we are excited to explore its safety and efficacy as a potential treatment for patients with PJI.” Jonathan Steckbeck, Ph.D., Founder and CEO of Peptilogics PLG0206 is an investigational broad-spectrum, anti-biofilm, anti-infective peptide therapeutic. The current standard of care for PJI includes numerous high-risk surgical procedures coupled with systemic antibiotic treatment, which are often ineffective due to device-associated biofilms. PLG0206 was designed with a unique mechanism of action that allows it to directly addresses biofilm bacteria and persistent pathogens that evade standard of care antibiotics by targeting and disrupting bacterial membranes to trigger bacterial cell death. PLG0206 has demonstrated best-in-class, rapidly bactericidal, broad-spectrum activity against a variety of pathogens, regardless of resistance phenotype, identified by the World Health Organization and the Centers for Disease Control as critical, urgent or high priority targets. PLG0206 has previously been granted FDA Orphan Drug Designation for the treatment of PJI and has been designated as a Qualified Infectious Disease Product (QIDP) as well. In December, Peptilogics announced the publication of two peer-reviewed studies on PLG0206. Data from a first-in-human Phase 1 study of PLG0206, published in Antimicrobial Agents and Chemotherapy, showed the investigational therapeutic was safe and well tolerated and has favorable pharmacokinetics when intravenously administered as a single dose. These data were presented in September at ID Week. Data from a clinical proxy study of PLG0206, published in Microbiology Spectrum, showed the investigational therapeutics’ ability to reduce bacteria on chronically infected prosthetic knee joints, which may translate to improved clinical outcomes. About Periprosthetic Joint Infection (PJI) More than one million total joint replacements are performed annually in the U.S., a number that is expected to grow to four million annual procedures by 2030 due to an aging and active population. Following joint replacement, 1-2% of patients will develop a PJI, a serious life-threatening condition which often necessitates continuous antibiotic usage and high-risk surgical procedures with limited ability to resolve the infection. The current standard of care has up to a 60% failure rate and results in a substantial number of patient deaths, evidenced by a 25% five-year mortality rate. About Peptilogics Peptilogics engineers peptide therapeutics to radically improve the treatment landscape for patients with life-threatening diseases. Through biological and pharmaceutical expertise, novel artificial intelligence algorithms, and purpose-built super-computing, Peptilogics is developing an extensive therapeutic pipeline and accelerating discovery efforts at a pace and scale that was previously impossible. Peptilogics is backed by visionary investors in life science and technology including Peter Thiel, Presight Capital, CARB-X, and Founders Fund.

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CELL AND GENE THERAPY

Valneva and IDT Biologika Announce Collaboration for Production of Inactivated COVID-19 Vaccine VLA2001

Valneva SE, IDT Biologika | November 30, 2021

Valneva SE, a specialty vaccine company, and IDT Biologika announced their collaboration for the production of Valneva’s inactivated COVID-19 vaccine candidate VLA2001. This follows last week’s announcement that Valneva signed an Advance Purchase Agreement with the European Commission to supply up to 60 million doses of VLA2001, over two years. Under the collaboration, IDT Biologika will produce VLA2001’s drug substance at its Biosafety Level 3 facilities in Dessau-Roßlau, Germany, in addition to Valneva’s manufacturing site in Livingston, Scotland. “IDT is a well-established partner within Valneva’s manufacturing network. As such we are extremely pleased to extend this partnership to supply VLA2001. This collaboration will help ensure our inactivated vaccine is available for rapid deployment as we continue to believe that our differentiated vaccine candidate can make an important contribution to the global fight against the COVID-19 pandemic.” Thomas Lingelbach, Chief Executive Officer of Valneva Dr. Jürgen Betzing, Chief Executive Officer of IDT Biologika, added, “This is great news for our company. This assignment shows the importance of the role played by IDT in the fight against COVID-19. It is a great achievement and demonstrates the trust that Valneva has placed in us and our employees. The expansion of our production capacity combined with our expertise were key factors in the choice of IDT.” Valneva has continued to review its manufacturing strategy following discussions with the UK Government in the summer and again after the termination of the UK contract in September 2021. Valneva plans to operate a combination of external and internal production of VLA2001 and will further review its manufacturing plans based on demand. The Company’s sites in Livingston, Scotland and Solna, Sweden will continue to form part of the Company’s core manufacturing strategy. Valneva reported positive Phase 3 results for VLA2001 in October 20211. Delivery of the vaccine in Europe is currently expected to begin in April 2022, subject to approval by the European Medicines Agency which is expected to start a rolling review of VLA2001 shortly. About VLA2001 VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements. About Valneva SE Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. About IDT Biologika IDT Biologika is an innovative biotech company with a successful history dating back 100 years. On the basis of modern technologies and high levels of expertise, we support customers in the development and manufacture of innovative virus vaccines, gene and immune therapy products as well as biologics employed worldwide as protection against diseases. German sites are the BioPharmaPark in Dessau-Roßlau and Magdeburg. In the US, the IDT Corporation has a manufacturing site for clinical test samples in Rockville, Maryland.

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RESEARCH

AlivaMab Discovery Services is Expanding the Drug Discovery Platform with the Introduction of New Antibody Engineering Department

AlivaMab | May 13, 2021

AlivaMab Discovery Services, LLC ("ADS"), a pioneer in the discovery of superior antibody therapeutics, announced today the formation of its new Antibody Engineering Department, headed by Jonah Rainey, Ph.D. Jonah joins ADS as Vice President of Antibody Engineering, bringing 15 years of experience from Macrogenics Inc. in antibody engineering, discovery, and development, MedImmune, LLC/AstraZeneca PLC, Gritstone Bio, Inc., and, most recently, Immetas Therapeutics, Inc. Jonah's expertise in antibody engineering includes bispecific antibodies, some of which have reached clinical trials, antibody-drug conjugates, Fc modification, in vitro display for antibody discovery and optimization, and structural modeling. “An increasing number of leading pharma and biotechs realize that ADS's pre-existing platform process adds exceptional value to their antibody drug discovery efforts. I am excited to be leading the initiative at ADS to develop new capabilities that will expand the scope and importance that we offer to our clients' drug discovery and development projects. The new Antibody Engineering Department's commitment will help to ensure that ADS delivers the best antibody drug candidates,” said Jonah Rainey, Vice President of Antibody Engineering at AlivaMab Discovery Services. “Today, we significantly expand the ADS discovery platform by adding a new pillar of antibody engineering to our existing pillars of Ablexis' AlivaMab® Mouse, the leading transgenic animal technology for antibody drug discovery, a suite of AMMPD immunization technologies to address even the most challenging targets, a broad sampling of the immune repertoire through function-first high-throughput deep sequencing, and a broad sampling of the immune repertoire through function-first high-throughput sequence analysis. “Jonah's skills and abilities complement and reinforce the ADS team's accumulated decades of experience in discovery and development. We assist our clients in delivering quality medicines to patients quicker by combining team, technology, and partnership.” About AlivaMab Discovery Services AlivaMab Discovery Services is a privately-owned biotechnology company that develops an integrated antibody therapeutic discovery platform that combines innovative technologies and deep expertise to produce superior antibody therapeutics on time. Throughout their careers, the team has completed over 200 discovery projects, yielding several antibody drug candidates in clinical trials. ADS offers a wide range of antibody therapeutic candidates with complex molecular and epitope profiles, functional and kinetic characterization, and superior developability profiles.ADS is trusted by organizations ranging from global pharmaceutical firms to virtual biotechnology companies because of its business model that relies solely on partners instead of developing an internal product pipeline.

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