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AmplifyBio News

Mitigating Risk, Maximizing Quality: AmplifyBio’s Data Integrity Journey

By: Amy Adams, Systems Analyst At AmplifyBio, we understand the critical role data integrity plays in achieving successful outcomes. While spreadsheets are a cornerstone of many businesses, they can introduce errors due to their inherent ease of use and accessibility. This is especially concerning in GxP-regulated environments, where compliance with 21 CFR Part 11 is essential. To ensure our data’s continued quality and compliance, we’re

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AmplifyBio Expands Capacity for Advanced Therapy Pathology Services

An integral part of AmplifyBio’s vision is to continuously assess the needs of our clients and invest in valuable, differentiating, and translational capabilities to serve the needs of advanced therapy development. An example of that commitment comes from the growth of cell and gene therapy and other biologic modalities, causing a notable shift in the types of pathology assessments that best determine the safety and

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AmplifyBio and Xcell Biosciences Announce Partnership to Manufacture Solid Tumor-Targeting TCR-T Cell Therapy

Companies will jointly work through process development, preclinical analysis, and first-in-human trials using Xcellbio’s AVATAR FoundryTM platform SAN FRANCISCO and SOUTH SAN FRANCISCO, CA — May 20, 2024 – Xcell Biosciences Inc. (Xcellbio), an innovative technology company focused on cell and gene therapy manufacturing applications, and AmplifyBio, a rapidly growing contract development and manufacturing organization, today announced the launch of a partnership designed to streamline

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AmplifyBio Streamlines CGT Discovery, Safety, and Manufacturing Services with Benchling Cloud

[West Jefferson, Ohio] — AmplifyBio, a leading provider of advanced therapy discovery, safety, and manufacturing services, announces the implementation of Benchling’s cloud-based unified scientific data platform across all service areas. The integration of Benchling further signifies AmplifyBio’s commitment to streamlining workflows, enhancing collaboration, and ultimately accelerating cell and gene therapy development and commercialization for its clients. Benchling will now serve as AmplifyBio’s centralized data repository for critical

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AmplifyBio and RNAV8 Bio Announce Strategic Partnership to Support mRNA Therapeutic Developers from Sequence Design to GMP Manufacture

AmplifyBio and RNAV8 Bio Announce Strategic Partnership to Support mRNA Therapeutic Developers from Sequence Design to GMP Manufacture AmplifyBio, a Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO)  focused on differentiating services that cover target optimization, preclinical safety studies, and manufacturing scale-up, and RNAV8 Bio, an emerging startup focused on mRNA engineering platforms, are partnering to provide a one-stop shop for the

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SQA 2024 Presentation: Building Resilient GxP Quality Processes to Support Business Needs

AmplifyBio presented in the Beyond Compliance Specialty track at the Society of Quality Assurance 2024. The presentation, titled “Building Resilient GxP Quality Processes to Support Business Needs,” discusses AmplifyBio’s journey of implementing our eQMS, Veeva, and, more importantly, the evolution of the quality processes behind the system. AmplifyBio’s shift from a compliance culture to a quality culture is driven by the desire to move beyond

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AmplifyBio Gears Up for CGT Aerosol Testing

AmplifyBio recently acquired two Class III biosafety cabinets (BSCIII) to facilitate the evaluation of Cell and Gene Therapy (CGT) treatments for respiratory diseases in vivo. Many promising CGT products target respiratory illnesses. Delivering these therapies directly to the lungs via inhalation is a highly efficient and targeted approach. However, ensuring researcher safety during aerosol evaluation requires specialized equipment and rigorous protocols. Recognizing the potential safety

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AmplifyBio Streamlines Inhalation Studies with Faster Setups, Automated Analysis

At AmplifyBio, we’re constantly innovating to streamline the process of conducting inhalation studies. By implementing new processes and technologies, we’ve significantly reduced the time and cost associated with these critical research endeavors. Traditionally, setting up and characterizing inhalation exposure systems could take nearly two months. We’ve strategically built a library of standardized exposure system components, allowing us to rapidly assemble them for each new study.

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The End of Buy vs. Build Analyses in Manufacturing: Making Way for Hybrid Approaches and Better COGS

An abridged transcript of the fireside chat from January 17th, 2024, at Advanced Therapies week in Miami, Florida with J. Kelly Ganjei, CEO AmplifyBio.   Moderator: What led you to the strategy for building Amplify Bío that includes advanced characterization services, safety and tox preclinical services, and manufacturing in an unconventional model that allows for the client to drive staffing model and technology platform used in

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AmplifyBio Celebrates Grand Opening of Manufacturing Enablement Center in New Albany, Ohio

AmplifyBio Celebrates Grand Opening of Manufacturing Enablement Center in New Albany, Ohio [New Albany, Ohio, February 1, 2024] — AmplifyBio, a leading commercialization partner for advanced therapies that include cell and gene therapies, proudly announces the successful grand opening of the AmplifyBio Manufacturing Enablement Center (AMEC) in New Albany, Ohio. The milestone event follows the addition of a site dedicated to drug discovery, optimization and

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Immunological Testing for Gene Therapy Success

By: Victoria Best Ph.D. In the era of advanced therapies and personalized medicine there is an ever-increasing need for the development of immunological tests that are readily available, standardized in their approach, and affordable. Specialized immunological testing is often required to better understand a particular drug’s potency, stability, mechanism of action, potential off-target effects, and overall efficacy. This is true even if the therapeutic is

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AmplifyBio: Championing Digital Transformation in Advanced Therapy with ValGenesis and Beyond

For AmplifyBio, adopting a robust digital strategy across our functions goes beyond mere convenience; it’s a strategic imperative. It enables us to provide the efficiencies, protection, and real-time data analysis essential for meeting our clients’ needs. Embracing this digital transformation offers myriad benefits, extending far beyond mere cost savings. Enhanced data integrity, regulatory compliance, and our ability to be at the forefront of digital strategies

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AmplifyBio Goes Live with ValGenesis VLMS

SANTA CLARA, Calif., Dec. 12, 2023 /PRNewswire/ — ValGenesis, Inc., the market leader in enterprise validation lifecycle management solutions, announced that AmplifyBio, a rapidly growing contract research organization (CRO), successfully went live with the ValGenesis validation lifecycle management system (VLMS) to efficiently manage digital validation processes.   AmplifyBio spun out from Battelle, the world’s largest independent nonprofit applied science and technology organization, as a preclinical CRO designing and

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AmplifyBio Expands Its Vision: Launches Advanced Therapy Manufacturing Enablement Center in New Albany, Ohio

NEW ALBANY, Ohio, November 28, 2023 (Newswire.com) – AmplifyBio, a leading contract research organization, is announcing the opening of a new business unit to further expand its reach into the manufacturing of next-generation therapies that include cell, gene, mRNA, and other advanced modalities. The Amplify Manufacturing Enablement Center (AMEC), located 30 minutes from their West Jefferson headquarters in New Albany, Ohio, will comprise individual manufacturing

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AmplifyBio Selects Apprentice.io’s Tempo Manufacturing Execution System to Supercharge Manufacturing Capabilities as They Expand Capacity

WEST JEFFERSON, Ohio, November 7, 2023 (Newswire.com) – AmplifyBio, a leading service provider in discovery, safety, and manufacturing services for the development of advanced therapies, has chosen Apprentice.io’s cutting-edge Tempo Manufacturing Execution System (MES) to expand production capabilities and meet the increasing demand for modern modality commercialization on shorter de-risked timelines. Apprentice’s, no-code, fully cloud-native MES is equipped with the power and flexibility necessary to

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AmplifyBio and Vector BioMed Partner to Manufacture Plasmids and Share Capabilities that Enhance the Safety and Scalability of Lentiviral-based Gene Therapeutics

WEST JEFFERSON, Ohio, & GAITHERSBURG, Md., October 31, 2023 (Newswire.com) – AmplifyBio, a leading service provider for the commercialization of advanced modality therapeutics, and Vector BioMed, a biomanufacturing company specializing in the manufacture of lentiviral vectors, announced a strategic partnership that aims to accelerate the development of lentiviral vector-based gene therapeutics. This collaboration brings together two industry leaders: a lentiviral vector manufacturer and an advanced

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Maximizing Data Integrity in Safety Pharmacology Studies: Navigating Pitfalls for Reliable and Interpretable Results

Maximizing Data Integrity in Safety Pharmacology Studies: Navigating Pitfalls for Reliable and Interpretable Results By: Dr. Michael Stonerook Safety pharmacology studies play a crucial role in drug development by assessing new compounds’ potential risks and effects on various physiological systems. However, these studies can encounter several pitfalls that may lead to disruption and compromised data interpretation. While it is essential to design robust studies, over-designing

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AmplifyBio Completes Acquisition of Intellectual Property to Offer Non-Viral Gene Editing Services for Clients

WEST JEFFERSON, Ohio, July 12, 2023 (Newswire.com) – AmplifyBio, a leading service provider for the commercialization of advanced modality therapeutics, such as cell and gene therapies, today announced the successful acquisition of a cutting-edge intellectual property (IP) that, among other capabilities, will allow them to offer non-viral gene-editing services to clients. The move represents a significant milestone in AmplifyBio’s mission to assemble tools and technologies that

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AmplifyBio Celebrates 2 Years of Innovative Solutions in Preclinical Drug Development and Safety

WEST JEFFERSON, Ohio, May 25, 2023 (Newswire.com) – AmplifyBio, an organization built from a preclinical CRO, launched out of Battelle in 2021 and dedicated to building a full-service advanced therapy commercialization hub, is proud to celebrate its two-year anniversary. Since its inception, AmplifyBio has been committed to improving the speed and cost-effectiveness of bringing safe, efficacious therapeutics to patients.  Over the past two years, AmplifyBio has

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AmplifyBio Adds Manufacturing Capabilities to Expand Service Portfolio

AmplifyBio is adding manufacturing services, starting with cell therapy and plasmids, to its growing capabilities to support the safe development of advanced therapies. WEST JEFFERSON, Ohio, May 15, 2023 (Newswire.com) – AmplifyBio, an emerging hub for the commercialization of advanced therapies, has announced the addition of cell therapy and plasmid manufacturing capabilities to its leading portfolio of preclinical CRO and drug characterization services. The GMP cell therapy

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Advancing Preclinical Research with Modern Data Automation Techniques

Advancing Preclinical Research with Modern Data Automation Techniques The safety, efficacy, and toxicology testing at AmplifyBio (A-SET) often requires the processing of data generated by sophisticated lab instruments, followed by complex biostatistical analysis to achieve the desired results for any given preclinical study. Performing this intricate data analysis requires a considerable amount of effort and precise execution, which can lead to a depletion of resources

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AmplifyBio Neuroscience Blog Post

AmplifyBio’s Preclinical Neuroscience Studies: Leveraging Decades of Expertise We’re thrilled to have Deepti Nair, Study Director of neurological studies, answer a few questions about AmplifyBio’s neuroscience capabilities and the potential for the future. Please describe your background in preclinical research and neurology. What led you to AmplifyBio?  I am an experienced behavioral neuroscientist with a Ph.D. in Neurophysiology. My passion for neuroscience began during my

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Dispatch Media Group Names AmplifyBio a Winner of The Columbus Top Workplaces 2023 Award

PRESS RELEASE • APR 3, 2023 07:00 EDT WEST JEFFERSON, Ohio, April 3, 2023 (Newswire.com) – AmplifyBio has been awarded a Top Workplaces 2023 honor by Columbus C.E.O. Magazine Top Workplaces. The list is based solely on employee feedback gathered through a third-party survey administered by employee engagement technology partner Energage LLC. The confidential survey uniquely measures 15 culture drivers that are critical to the success of any organization: including alignment,

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AmplifyBio Discovery Optimization Characterization Blog

AmplifyBio’s Discovery, Optimization, & Characterization of Cell Therapies in a Pre-Clinical Setting In this blog, Eric Kunkel, Vice President of Research and Development at AmplifyBio’s new “DOC” (discovery, optimization, and characterization) facility in South San Francisco, walks us through some of the benefits that the team can offer clients developing advanced therapies.  Can you explain the background that you and the team have in characterizing

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AmplifyBio Emerges as a Leader in Cell Therapy Characterization, Filling a Gap in Pre-Clinical Development

AmplifyBio builds on the T-cell immunology expertise of its South San Francisco-based team, adding technology platforms and capabilities in single-cell analysis and product assessment in the context of a tumor microenvironment. PRESS RELEASE  MAR 16, 2023 07:00 EDT SAN FRANCISCO, March 16, 2023 (Newswire.com) – AmplifyBio, a preclinical CRO provider, spun out from the Battelle corporation in mid-2021, signaled the intention to build on discovery and characterization

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AmplifyBio to Attend SOT 2023

AmplifyBio to Attend SOT 2023 Join AmplifyBio at the Society of Toxicology 62nd Annual Meeting and ToxExpo, March 19-23, 2023, at the Nashville Music City Center in Nashville, Tennessee. We’re excited to be exhibiting at Booth #1421, where we hope to meet some of you and discuss how AmplifyBio preclinical CRO services can empower your studies. Request a Meeting

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Since spinning out of Battelle, AmplifyBio has amplified both staff and its research mission

February 13, 2023 09:00 ET | Author: Carrie Ghose, Columbus Business Journal We’re absolutely thrilled that our recent growth to over 300 employees was covered by the Columbus Business Journal, and we can’t wait to continue growing our capabilities to serve the needs of advanced therapeutic development. Read the article here. AmplifyBio has seen a surge in clients looking to bring regenerative medicine to market, adding 28

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AmplifyBio Secures $50M in Debt Financing With Hercules Capital to Accelerate Business Plan

AmplifyBio announces $50M in debt financing to accelerate the expansion of its service offering, supporting the rapid, safe development of next-generation therapeutics January 12, 2023 09:00 ET | Source: AmplifyBio WEST JEFFERSON, Ohio, Jan. 12, 2023 (GLOBE NEWSWIRE) — AmplifyBio announced that it had augmented its balance sheet with non-dilutive debt financing, whereby it may borrow a principal amount of up to $50 million from Hercules Capital, Inc. (NYSE:

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Battelle, AmplifyBio, Andelyn Biosciences Win Research Contract for National Institute of Neurological Disorders and Stroke

COLUMBUS, Ohio (Jan. 6, 2023)—The team of Battelle, AmplifyBio and Andelyn Biosciences has won a seat on an eight-year, $149 million indefinite delivery, indefinite quantity (IDIQ) contract vehicle for the National Institute of Neurological Disorders and Stroke. As one of the prime contractors on the multi-award IDIQ, the team will provide manufacturing and nonclinical support for translational development of therapeutic biotechnology products in the National

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AmplifyBio to Attend Advanced Therapies Week 2023

AmplifyBio to Attend Advanced Therapies Week 2023 Join AmplifyBio at the Advanced Therapies Week 2023, January 17-20, 2023, at the Miami Convention Center in Miami Florida. We’re excited to be exhibiting at Booth #611, where we hope to meet some of you and discuss how AmplifyBio preclinical CRO services can empower your studies. Request a Meeting

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AmplifyBio Inhalation Blog Post

AmplifyBio Inhalation Blog We’re thrilled to have our Scientific leadership for inhalation toxicology answer a few questions about AmplifyBio’s inhalation capabilities and the potential for the future regarding this complicated route of administration. Please describe your background in preclinical research and inhalation Toxicology. Roy Barnewall: I received my Ph.D. in microbiology and pathology and a Doctorate in Veterinary Medicine from Ohio State University in 1999.

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AmplifyBio Honored at Columbus First’s Annual Biztech Inno Fire Awards

AmplifyBio was honored as one of the most Innovative companies to watch in the Columbus area in 2022. We are honored to appear on a list of companies growing science and technology in the central Ohio region.   The event highlighted up-and-coming companies and entrepreneurs with Business First carrying on the long tradition of the former TechColumbus TopCat Awards and Innovation Awards with our BizTech Awards. 

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AmplifyBio Partners with Blue Mountain to Streamline Asset Management

AmplifyBio’s Partnership with Blue Mountain – A Q&A with Amy Adams, IT Project Coordinator We’re thrilled to have our IT Project Coordinator, Amy Adams answer a few questions about the new changes in regulatory asset management with Blue Mountain, and how that fits with the larger IT strategy at AmplifyBio.  Please describe your background in Quality systems. What led you to AmplifyBio? I have previously

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AmplifyBio Chooses Blue Mountain to Achieve GMP Compliance and Advance Digital Strategy

A Fast-growing preclinical CRO, AmplifyBio is partnering with the SaaS leader in Good Manufacturing Practice (GMP) Solutions, Blue Mountain, to manage the maintenance, calibration and validation processes of their assets. West Jefferson, Ohio — December 1st, 2022 —Amplify Bio has selected Blue Mountain Regulatory Asset Manager (RAM) to help with incorporating industry best practices and ensuring electronic records compliance. “Blue Mountain RAM will enable us

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AmplifyBio Announces Completion of Initiatives to Expand Vivarium Capacity

Preclinical CRO Capacity Expansion WEST JEFFERSON, Ohio, November 10, 2022 (Newswire.com) – AmplifyBio, a contract research organization that is building an ecosystem for the advancement of advanced therapies, today announced the completion of initiatives to expand capacity and reduce timelines for the execution of preclinical CRO services. The projects, which took a little over a year to complete, involved talent recruitment, vivarium modifications, supply chain management, and

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The Modern Pathology Lab – blog

Modernizing the Pathology Lab With Dr. Sabrina McGraw We’re thrilled to have our director of pathology, Sabrina McGraw, DVM, Ph.D., answer a few questions about the exciting new changes coming to AmplifyBio’s pathology lab. Here, she’ll discuss how cutting-edge technology is not only modernizing her lab but enabling better partnerships with clients as well.   Please describe your background in preclinical research and pathology. What

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AmplifyBio to Attend American College of Toxicology 2022

AmplifyBio to Attend American College of Toxicology 2022 Join AmplifyBio at the American College of Toxicology’s ACT 43rd Annual Meeting, November 13-16, 2022, at the Gaylord Rockies in Denver Colorado. We’re excited to be exhibiting at Booth #600, where we hope to meet some of you and discuss how AmplifyBio preclinical CRO services can empower your studies. Request a Meeting

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AmplifyBio Acquires Pact Pharma Assets to Enhance Cell and Gene Therapy Characterization Capabilities

AmplifyBio Acquires Pact Pharma Assets to Enhance Cell and Gene Therapy Characterization Capabilities Acquisition of select PACT assets enables AmplifyBio to expand beyond safety, efficacy, and toxicology services to enable “living medicine” developers to shorten timelines and mitigate risk when moving to the clinic. WEST JEFFERSON, Ohio, and SOUTH SAN FRANCISCO, Calif., Oct. 3, 2022 – AmplifyBio, a preclinical contract research organization (CRO) focused on accelerating

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AmplifyBio Announces in May Plans to Expand Into the Columbus Region

  AmplifyBio Announced in May Plans to Expand  Into the Columbus Region May 23, 2022 Columbus, Ohio – AmplifyBio, a biotechnology contract research organization (CRO) that aims to advance the quality and innovation of human health and advanced therapies, is expanding in the Columbus Region, investing approximately $150 million in a new 350,000-square-foot New Albany facility. With this investment, the company is also creating 263

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Optimizing Preclinical AAV Safety 2022 Slides by Dr. Victoria

Dr. Victoria Best’s Safety Summit 2022 Q&A Download the slides from Dr. Victoria Best’s talk at Optimizing AAV Safety 2022 about assessing preclinical safety signals derived from AAV gene therapies.   Synopsis: Opportunities to Expand AAV Safety Data, Benchmarking, and Harmonization at the Preclinical phase Issues the FDA is going to pay more attention to soon. Lab developed test validation, identifying correlates and biomarkers of

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From Discovery to Preclinical – Utilizing Analytics to Empower the Study Process

From Discovery to Preclinical – A Q&A with Dr. Victoria Best, Director of Analytical Sciences What is your background in preclinical research? I have a PhD in immunology, and I have spent most of the last 20 years in an academic research setting. I spent 10 years doing discovery immunology in animal models and in humans and another 5 years in a clinical research space

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AmplifyBio Celebrates One Year Since Launch With an Expansion of Capabilities and Capacity and a New Site

In the first year, AmplifyBio achieved the primary strategic goals of increasing capacity by 50% and adding a state-of-the-art analytics laboratory. Assessing biodistribution, gene expression, vector integration, and monitoring immune responses alongside preclinical work provide the data necessary to modify study designs, improve efficiencies, compress timelines, and reduce costs.

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AmplifyBio to Drive Quality Excellence with Veeva Vault Quality Suite

AmplifyBio to Drive Quality Excellence
with Veeva Vault Quality Suite

PLEASANTON, CA — May 3, 2022 – Veeva Systems (NYSE: VEEV) today announced that AmplifyBio is building a foundation for advanced quality, study execution, and reporting with Veeva Vault Quality Suite. Using a modern quality system with built-in industry best practices, the company will streamline and automate processes to increase the efficiency of its preclinical drug testing. “At AmplifyBio, we generate and report critical data through short and

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AmplifyBio to Attend Society for Toxicology 2022

AmplifyBio will be exhibiting at the Society of Toxicology Meeting in San Diego, California: May 27th – May 31st. Like many people, the team at AmplifyBio is looking forward to getting out and meeting with customers and colleagues in person again.  AmplifyBio is a leading preclinical CRO services provider focused on toxicology, safety and pharmacology testing to advance therapeutics for the betterment of human health. Spun out

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Battelle, Partners to Form New Company: AmplifyBio

$200 million start-up will focus on development of next generation therapies COLUMBUS, Ohio (May 3, 2021) — Battelle announced today that it is launching a new company that will focus on the research and development of next generation therapies such as cell and gene therapies (CGT). AmplifyBio will operate on its own 30-acre dedicated footprint within Battelle’s West Jefferson, Ohio campus. The new company has the

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