eBooks

Immunotherapy: Taking Aim at Solid Cancers

As cell and gene therapies arrive on the market, all eyes have focused on autologous chimeric antigen receptor (CAR) T – cell therapies. At the 2019 Phacilitate Leaders World and Stem Cell Summit in Miami, FL, delegates looked at where the biopharmaceutical industry is going in the cellular immunotherapy space. Whether for off-the-shelf CAR T-cell products, personalized cancer vaccines, or modified natural killer (NK) cells derived from human induced pluripotent stem cells (iPSCs) — cell and gene therapy development is…

Supply Chain Solutions for Cell and Gene Therapy Companies

Stakeholders across the supply chain stress that quality of starting material will be key to the success of cell and gene therapies. This is a topic that has created issues in the past, is puzzling the industry presently, and is likely to cause more problems going forward. This topic was front and center at the 2019 Phacilitate Leaders World and World Stem Cell Summit in Miami FL, with presentations focusing on supply chain solutions to address these complex challenges; cell…

Automation in Cell and Gene Therapy Development

The US approvals of chimeric antigen receptor (CAR) T-Cell therapies Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) and gene therapy Luxturna (voretigene neparvovec) in 2017 heralded a “new frontier of medicine.” But with great innovation comes great costs and criticism (such as the Kymriah’s US$475,000 price tag). Many companies argue that these one-off therapies represent good value for patients and payers compared with traditional treatments, however, no matter your perspective, the COGs picture for cell and gene therapies isn’t good and…

Manufacturing of Cell and Gene Therapies

The peak of demand for curative cell and gene therapies will be unlike that of traditional drugs and thus could cause forecasting and overcapacity issues going forward. Predicting the future is always difficult, and poor decisions can be costly and highly damaging for a company. At the 2019 Phacilitate Leaders World and Stem Cell Summit in Miami, FL, several presentations and conversations focused on the forecasting dilemma and how manufacturing needs innovation, just to name two. This eBook details these…

eBook: Allogeneic Cell Therapies Commercialization Strategies

Manufacturers of allogeneic cell therapies face development and commercialization challenges unlike those of traditional cell therapies. In a discussion with Phil Vanek of GE Healthcare, we outline several of the key challenges of processing these products and bringing them to market. Approaches for reducing development costs and lowering pricing are highlighted, and a separate analysis presents three pricing models specific for allogeneic “off the shelf” cell products.

Biopharmaceutical Characterization, Part 2: Applications and Strategies for Diverse Products — A Conference Report

Last fall, KNect365 brought together more than 250 analytical specialists to discuss biological assays and characterization of well-characterized biologics in Rockville, MD. Speakers from the US Food and Drug Administration joined experts from leading biopharmaceutical companies, service providers, and consultancies for case studies, regulatory interactions, sharing perspectives, and learning about emerging technologies. Part 1 of this report in January 2019 focused on the bioassay section of the meeting. Here in Part 2 sponsored by Sartorius, BPI’s senior technical editor reports…

eBook: Efficient Production of Adherent Cells – The Bolt-On Bioreactor Project, Next Phase

Some years ago, The Bolt-on Bioreactor (BoB) project was launched with an objective of bringing to the market an efficient bioreactor for culturing adherent cells. The BoB team identified four challenges that needed be addressed to succeed: volumetric productivity, process automation, containment and sterility, and process economics. BPI published findings related to those challenges and proposals of the BoB team to solve them in a four-article series in 2015. Here, the author offers an update on developments in The Bolt-on…

eBook: Vaccines – Industry Collaborations to Increase Uptake

Vaccines save millions of lives every year, and the continuing increases in the number of administered doses and worldwide distribution of vaccines for long-standing diseases such as polio and malaria have contributed to the improvement in public health. Vaccine developers and manufacturers are partnering with private and government agencies to raise global vaccine uptake by addressing remaining challenges with production capacity, distribution, safety, and accessibility. And the implementation of new technologies such as virus-like particles and cell/DNA-based vaccines are helping…

eBook: Expression Systems — Increasing Productivity and Reducing Costs

Biopharmaceutical manufacturers are facing increasing pressures to improve productivity and reduce time to clinic and market. Increasing productivity begins with selecting the appropriate expression system for each protein. Current efforts to boost expression titers also are focused on implementing selection/screening technologies, engineering Chinese hamster ovary (CHO) expression systems, and accelerating timelines for the development of complex next-generation therapies. BioProcess International asked three representatives of the industry’s leading companies to comment on current expression system technologies and strategies Just fill out this…

BioProcess International Europe 2019 Event Report

BioProcess International Europe has distinguished itself as a must-attend event for industry decision makers around the world. While complementing and connecting to content delivered at all BPI events, this conference delivers unique and applicable information not presented anywhere else. Here, BioProcess International’s publisher and senior technical editor offer their perspectives on this year’s meeting in Vienna, Austria, with a program overview and exploration of themes that arose from the sessions and talks: from accelerated cell-line engineering to continuous bioprocessing, new…