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
Spray drying is an established particle engineering technology that offers several advantages over other methods used for improving API bioavailability.
Dry granulation can be a method to overcome caking issues and improve handling of buffers, salts and stabilizing chemicals during pharmaceutical manufacturing.
Alex Garner will work to further expand and strengthen Avomeen’s formulation and clinical trial manufacturing capabilities to support biopharmaceutical clients.
Collaboration will increase access to Actinium-225, a medical isotope used with radiopharmaceutical drugs in clinical trials for advanced cancer therapy.
The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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.
Biovac will perform manufacturing and distribution activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network.
Initial phase includes installation of two 2,000-liter single-use bioreactors and associated investments to support early-and late-phase clinical development.
Strengthens cell therapy pipeline with individualized solid tumor Neoantigen TCR cell therapy R&D program and adds manufacturing footprint in North America.
Acquisition is part of the cigarette maker’s ‘Beyond Nicotine’ strategy and expands its product pipeline development capabilities in inhaled therapeutics.
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.
How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.
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.
Collaboration investigates enhanced manufacturing of AAV and lentiviral vectors to improve quality and productivity for gene therapy and vaccine developers.
ProBioGen to provide cell line development, process development and GMP manufacturing at 1000 L bioreactor scale of Asher's lead immuno-oncology candidate.
Evotec's first commercial biomanufacturing facility in Europe is anticipated to deliver much needed capacity for biotherapeutic development and manufacturing.
Increases capabilities and capacity to provide anti-infective testing, assay development and biomaterial production services for highly infectious pathogens.
Aims to provide improved product tracking, scheduling and live monitoring of the manufacturing status across the entire CGT supply chain from vein to vein.
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.
Celonic is prepared to manufacture more than 100 million doses of CureVac’s mRNA-based COVID-19 vaccine candidate, CVnCoV, per year at Heidelberg facility.
To show the impact to autologous and allogeneic cell therapies by integrating novel transfection technology with other steps in the manufacturing process.
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.
Dendritic cell vaccine production capacity for personalized immune therapies increases from about 4 - 6 patients per month to about 40 - 45 patients per month.
Overcoming challenges of implementation and achieving increased volume, reduced timelines, decreased footprint, lower cost of goods, and increased flexibility.
Priyanka Gupta, Head of Market Entry Strategy for Protein Based Therapeutics, Sartorius03.09.21
The existing partnership for manufacture of NVX-CoV2373 has been expanded to increase production capacity and supply vaccines to the Korean Government.
Will focus on clinical and commercial clients, especially as Cognate expands its business with allogeneic and autologous on-demand cell and gene therapies.
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
With vaccines against COVID-19 on the horizon, our focus is shifting to 2021 and the major issues life sciences companies face and reasons for optimism.
Arda Ural , EY Americas Health Sciences and Wellness Industry Leader, Ernst & Young LLP12.11.20
Expect to produce globally up to 50 million doses in 2020, up to 1.3 billion doses by the end of 2021; ready to distribute within hours after authorization.
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.
ProBioGen is conducting cell line development, process development and GMP manufacturing of the mAb intermediates of Heidelberg’s ATAC molecules for cancer.
Karen will work to further expand the company's contract manufacturing business, which delivers GMP materials to third parties developing COVID-19 vaccines.
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.
In this white paper, Lubrizol Life Science Health reviews sterile pharmaceutical products, aseptic processing, methods of product sterilization and more.
To increase small molecule manufacturing capacity for additional scale-up of CleanCap messenger RNA capping technology for vaccine and therapeutic programs.
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
Jeffrey Bailey has led both public and private healthcare companies leveraging his leadership experience in commercial, supply chain and business development
Serge Bodart of IDDI provides insight on the pharma and biopharma trends impacting CROs, outsourcing in today’s market, and advances in clinical research.