Will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased, with approximately 200,000 doses expected to ship 3Q21.
The importance of reagent quality control, especially endotoxin testing, during CGT development and the selection of reagents and suppliers to ensure safety.
Garrett Perry, Technical Services Specialists at Teknova09.14.21
Designed for packaging development, materials testing and production, the unit performs forming, sealing and punching operations at sequential stations.
Alex Garner will work to further expand and strengthen Avomeen’s formulation and clinical trial manufacturing capabilities to support biopharmaceutical clients.
Emerging innovations and non-antibiotic approaches to address urgent need to control infectious diseases, including multiple-drug resistant ‘super-bugs’
Anshul Gupte will be responsible for technical and scientific oversight of client projects, reporting to John Ross, President of Metrics Contract Services.
Bikash Chatterjee of Pharmatech Associates discusses the reshoring trend, technologies and advances that could help deliver more manufacturing back to the U.S.
Market estimated to grow at CAGR of 20% from 2021 to 2028 due to an exponential rise in clinical pipeline along with rising number of regulatory approvals.
State-of-the-art R&D lab at Florence, KY site expands technical feasibility capabilities for long-acting delivery of small molecules, biologics and nucleotides.
Aims to address growing demand for scientific and technology solutions for remote data capture, hybrid virtual studies and decentralized clinical trials.
Designed to provide a fast, sensitive range of trace element analysis solutions capable of capturing the complete spectrum of high matrix samples in single run.
Initial phase includes installation of two 2,000-liter single-use bioreactors and associated investments to support early-and late-phase clinical development.
Cloud-based application allows verification of multiple clinical research sites’ source data to be completed remotely by specialist team at centralized location
Brings together THREAD's digital platform and Marken's clinical trial logistics services to create a single seamless workflow for clients and patients.
Will leverage integrated services from Selexis and KBI as part of Immatics’ development of TCR Bispecifics, designed to detect, target and attack tumor cells.
New product, Corning Valor RTU Vials with SG EZ-fill Technology, offers a unique combination of Corning Valor Glass vial attributes with SG EZ-fill integration.
Supports Mirus’ expansion of GMP production of its flagship product TransIT VirusGEN for large scale manufacturing of AAV and LV viral vectors for gene therapy.
CDMOs have been some of the biggest winners from COVID contracts and will see benefits for several more years to come. A Q&A with GlobalData’s Peter Shapiro.
Lonza’s Robert Beland discusses best practices for manufacturers to shorten development timelines, as well as some of the capabilities at the CDMO's Tampa site.
Increases capabilities and capacity to provide anti-infective testing, assay development and biomaterial production services for highly infectious pathogens.
How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.
Catalent to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other investigational programs.
New site in Haimen, Jiangsu province has been established following an invitation to participate in the Yangtze Delta Advanced Drug Development platform.
Lonza exits both softgels and liquid-filled hard capsules and NextPharma plans to broaden its technology offering into lipid based finished dosage forms.
More robust solutions for single-use cold-chain containers made with polytetrafluoroethylene fluoropolymers may be less susceptible to failure and breakage.
Recognizes manufacturing facility and processes are in compliance with GMP requirements and readiness to provide commercial aseptic fill/finish services.
Exclusive license agreement to incorporate Ajinomoto Co.’s AJICAP site-specific bioconjugation technology for the development of Bright Peak Immunocytokines.
35-year pharmaceutical industry veteran brings deep industry expertise and a track record of building successful, client-centric, growth organizations.
Will increase 7000L drug substance capacity (MFG21) and drug product capacity (DP11) for liquid and lyophilization within its global manufacturing network.
Dr. Murphy of ICON, provider of clinical services to Pfizer/BioNTech’s COVID vaccine program, discusses what it takes to conduct a vaccine trial of this scale.
Treatment could be used for people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease, complementing the vaccine.
Adds Project Farma's unique expertise to Precision's suite of end-to-end cell and gene therapy capabilities to support development and commercialization.
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".
Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups01.05.21
From discovery to intermediates, APIs & drug products, a CDMO needs expertise across multiple elements of the pharma process to deliver an integrated experience
Large shipping system capable of carrying thousands of doses of vaccines that may require temperatures as low as -80° C using liquid nitrogen technology.
Instead of closing its doors on China, Western pharma industry needs to take a balanced approach and perform proper due diligence based on objective criteria.
The labeling process is highly complex and constantly in flux, making it ideal for digital transformation, but AI and ML cannot be implemented overnight.
Kiran Chinnalla, Associate Director Global Regulatory Affairs, Julian Backhouse, Associate Director Regulatory Technology Product Management, Cham Williams, Associate Director Business Systems , IQVIA11.13.20
Single-dose intranasal vaccine for COVID-19 designed to generate a broad immune response with nasal mucosal immunity to prevent infection and transmission.
As a partner to the U.S. Government, GRAM's newest facility was designed to increase large-scale fill and finish capacity with room to expand as demand grows.
Offering now includes Clinical Site-to-Patient, Pharmacy-to-Patient and Depot-to-Patient services to enable medication delivery directly to patients' homes.
Karen will work to further expand the company's contract manufacturing business, which delivers GMP materials to third parties developing COVID-19 vaccines.
Patch could administer vaccines without traditional needles reducing the need for refrigeration in transport and storage, and possibly self-administration.
Fran L. DeGrazio of West discusses why and how vaccine development is different than drug development and the impacts of COVID-19 on vaccine development.
Launches PyroCell MAT System for in vitro Pyrogen testing to help ensure safety of parenteral pharmaceuticals during development, manufacture and release.
Part of SAFER@WORK program; publishes method for early detection of asymptomatic SARS-CoV-2 virus spreaders, that does not require human PCR clinical testing.
CDMO Binex responsible for large-scale manufacturing of clinical investigational material for PharmAbcine for its global Phase 2 trials of olinvacimab.
Dr. Ural of Ernst & Young LLP discusses market dynamics, enduring therapeutic areas, near term M&A, and how industry can use this time for transformation
Serge Bodart of IDDI provides insight on the pharma and biopharma trends impacting CROs, outsourcing in today’s market, and advances in clinical research.