Monday, November 16, 2020 Daily Archives

Scalability of Lentiviral Production with the CTS LV-MAX Lentiviral Production System in Bioreactors

by

The Gibco™ CTS™ LV-MAX™ Lentiviral Production System provides a scalable and high-yield lentiviral vector (LV) production platform. It is based on a high-density suspension culture of HEK293F–derived Viral Production Cells that have been optimized for viral production in chemically defined LV-MAX Production Medium. Scalable LV production of greater than 1 x 10⸠TU/mL LV (unconcentrated) can be achieved using our proprietary lipid nanoparticle transfection reagent in combination with an LV-specific enhancer and production supplement. All components work synergistically to help…

November 16, 2020

Drug Formulations Are Changing:
New Sterile Filtration Challenges in the Changing Landscape of Drug Formulations

by

Read about the challenges of sterile filtration of high concentration mAbs, liposomes, and lentiviral vectors, and how to solve them in this Special Report. Development of new, complex drug formulations has given us therapeutics with properties that are markedly different from traditional drug types. High viscosity or low surface tension formulations or large viral vector molecules can mean that sterile filtration processes, which are optimized for traditional drug types, are not as efficient for the new, complex formulations. Premature filter…

November 16, 2020

Technology Transfers – A Beginner’s Guide

by

Pharmaceutical developers are increasingly relying on external manufacturing partners for expertise to develop and commercialize their products. In fact, contract development and manufacturing organizations (CDMOs) now process and manufacture approximately 28 percent of the world’s prescription and non-prescription drugs. Innovation is coming from all corners of pharma including independent labs, scientific consortia, academia and government programs. These emerging sources of drug innovation often have excellent science but few resources and a lack of experience in commercializing formulations and drug product…

November 16, 2020

Bioprocess Selection and Economics: 5,000-L DynaDrive™ Bioreactor Shifting the Paradigm

by

This webcast features: Jeff Johnson, Founder and President, BioTech Design, LLC, Mark Thomas Smith, R&D Engineer, Thermo Fisher Scientific, and Kevin Mullen, Senior Product Manager, Thermo Fisher Scientific Single-use technologies enable a flexibility and modularity effectively unattainable with more traditional stainless-steel technologies, particularly in upstream bioprocesses. Single-use bioreactors up to 2,000 L are employed largely in preclinical- and clinical-stage bioprocesses to leverage this flexibility. As products reach commercial maturity, scales larger than 2,000 L frequently become desirable to take advantage…

November 16, 2020

Altimmune partners with Lonza on intranasal COVID-19 vaccine

by

The two companies ready AdCOVID for a commercial launch in 2021, with a clinical trial to begin in Q4. The next-generation of COVID-19 vaccines is already being developed, even with the first generation yet to reach the public. The companies involved are finding ways to differentiate their vaccines from the previous generation. This has led companies, such as Vaxart, to produce oral vaccine candidates and sees Altimmune further advance its intranasal vaccine candidate by signing a manufacturing deal with Lonza.…

November 16, 2020

Catalent reiterates confidence in the gene therapy sector

by

Gene therapies will help drive growth says Catalent, which reiterated its confidence despite recent setbacks in the sector. The contract development and manufacturing organization (CDMO) spoke about its growing gene therapy business during its first quarter earning call last week, explaining it is seeing ongoing “elevated demand†for this type of work. Revenue generated by Catalent’s biologics business – which covers biopharmaceutical manufacturing as well as cell and gene therapy production – was $377.1 million in the first quarter of…

November 16, 2020

TCR2 makes first steps into US with ElevateBio manufacturing deal

by

TCR2 Therapeutics has established manufacturing capacity in the US, as it looks to Phase II trials for its solid tumor candidate TC-210. ElevateBio will provide manufacturing and technical expertise for TC-210, a cell therapy that is currently in Phase I/II trials and being prepared to enter Phase II. The production will take place at ElevateBio’s BaseCamp, a 140,000-square-foot cell and gene therapy manufacturing facility based in Waltham, US. ElevateBio secured the funding for the site and its operations last year,…

November 16, 2020

Reliance on antiquated tech a business risk for CGT sector

by

Cell and gene therapy firms should swap outdated human error prone processes for innovative, flexible technologies, says consulting group CRB. The conclusion is based on the ‘Cell and Gene Therapy Industry Report,’ which included a survey of executives at firms developing advanced therapy medicinal products (ATMP). The goal was to look at the technologies and manufacturing methods used in the sector and the results suggest the sector has yet to find the best way of making products at commercial scale.…

November 16, 2020