CELL THERAPIES - The Challenges & Possible Solutions for Transferring Cell Therapy From the Bench to the Industry March 6, 2014

Lior Raviv, MMedSc, and Ohad Karnieli, PhD, discuss the significant emerging challenges in downstream processing of cell therapies focused mostly on allogeneic therapies.

PLATFORM TECHNOLOGY - The PTXΔLNP® Platform: On the Promise of Developing New LNPs for Tomorrow’s mRNA Therapies October 2, 2023

Charlotte Dunne, PhD, Katrin Radloff, PhD, and Leonidas Gkionis, PhD, review the PTXΔLNP platform and how it offers a synergistic sister technology to the mRNA platform to obtain potent mRNA-LNPs for therapeutic applications.

BIOLOGICS DEVELOPMENT - Five Steps to a Robust Cell Line Development Process October 2, 2023

Robert Gustines reviews the critical steps for designing and implementing a robust cell line development process to help overcome the obstacles that often hinder biologic production.

Shape(TX) Collaborates With Otsuka to Develop Novel AAV Gene Therapies for Ocular Diseases September 8, 2023

Shape(TX) and Otsuka Pharmaceutical Co., Ltd. recently announced a multi-target collaboration to develop intravitreally delivered adeno-associated viruses (AAVs) for ocular….

CELL & GENE THERAPY - Cell & Gene Therapy’s Everest – The Challenges & Opportunities That Will Shape Success September 5, 2023

Samir Acharya, PhD, Rajiv Vaidya, PhD, Laura Kerepesi, PhD, and Cyrill Kellerhals, MBA, provide their unique insights as they explore the challenges cell and gene therapy developers and manufacturers are currently facing, those they can expect to see in the future, and more critically, how to overcome them.

LIfT BioSciences Heralds a New Era of Affordable Effective Cancer Cell Therapies Simply Produced From iPSCs July 6, 2023

LIfT BioSciences recently announced successful proof-of-concept production of its patented cancer killing alpha neutrophils from induced….

EXECUTIVE INTERVIEW - TC BioPharm: Developing Platform Allogeneic Gamma-Delta T Cell Therapies for Cancer January 16, 2023

Bryan Kobel, CEO of TC BioPharm, discusses his company’s upcoming plans, therapeutic clinical trials, and the biotech landscape.

EXECUTIVE INTERVIEW - Syner-G BioPharma: A Track Record of CMC Excellence April 4, 2022

Prabu Nambiar, PhD, Founder and CEO Syner-G, discusses the company’s evolution, its approach to CMC, and the future of the organization.

EXOSOMES - The Next Evolution in Therapy Delivery Beyond the Cell Membrane: The Promise of Exosomes January 17, 2022

Linda Marbán, PhD, says perhaps the best way to get past the cell membrane is to deliver contents the same way that cells send information to each other. And that is by the exosome, which in the case of targeted therapy delivery, has been identified as an alternative that shows powerful promise.

EXECUTIVE INTERVIEW - Emergent CDMO: Making the Impossible, Possible for Biopharma Innovators October 4, 2021

Catherine Hanley, Vice President & Interim CDMO Business Unit Head at Emergent BioSolutions, discusses the company’s plans for current and future CDMO operations and client partnership opportunities.

Bayer to Advance Two First-of-its-Kind Cell & Gene Therapies for Parkinson’s Disease June 9, 2021

Bayer AG recently announced that BlueRock Therapeutics (BlueRock) successfully administered the first dose of its pluripotent stem cell-derived dopaminergic neurons, named DA01, to a….

SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions May 5, 2020

Contributor Cindy H. Dubin features several leading companies’ innovations in delivery devices as well as how contract parenteral manufacturers are addressing the ever-demanding challenges, issues, and opportunities related to delivering biologics and small molecules.

DRUG DELIVERY – ENHANZE (®): An Efficient Way to Optimize Biologic Therapies for Subcutaneous Administration April 30, 2019

Michael J. LaBarre, PhD, discusses how the ENHANZE drug delivery technology has the potential to improve the pharmacokinetic profiles of co-administered drugs through increased dispersion, absorption, and bioavailability.

DRUG DEVELOPMENT - Cell & Gene Therapies Calling for Innovation in Drug Development August 27, 2018

Lev Gerlovin and Pascale Diesel, PharmD, believe there is significant evidence to indicate that we are entering a golden age of gene and cell therapy development, and while industry works to advance these programs, the debate over new approaches in both structuring and financing clinical research is likely to continue.

AAV VECTOR MANUFACTURING - Challenges & Opportunities in the Manufacturing of AAV Vectors Used in the Delivery of Gene Therapy Treatments February 28, 2017

Daniel C. Smith, PhD, indicates there remains a clear need for improved process productivities, and the need to develop manufacturing processes that can be applied to a wide number of AAV-based viral vector therapeutic candidates.

ANTIGEN-SCREENING SYSTEM - Perfecting the Promise of T Cell Therapies for Infectious Disease & Cancer May 31, 2016

NANOSCALE COMPLEXES - A Novel Nanotechnology-Based Platform to Optimize Combination Cancer Therapies: Rational Development & Improved Delivery Using CombiPlex® January 7, 2016

Barry D. Liboiron, PhD; Arthur C. Louie, MD; et al describe how CombiPlex addresses the challenges facing the traditional development path of many contemporary drug combinations and provide clinical proof-of-principle evidence that this approach can yield marked improvements in efficacy and patient outcomes.

CELL CULTURE MARKET - 3D Cell Cultures: Next Generation & New Challenges November 19, 2015

Kevin James and Robert G. Hunter of BCC Research say significant growth within the biopharmaceuticals industry is spurring unprecedented innovation in and demand for cell culture products for the purposes of drug discovery and safety testing. While 2D cell cultures have been in laboratory use since the 1950s, the market for 3D cultures has witnessed spectacular growth throughout the past decade.

STANDARDIZATION TECHNOLOGY - Innovative Temperature Standardization Technology Supports Cell Therapy Clinical Trials March 2, 2015

Rolf O. Ehrhardt, MD, PhD, and Maria Thompson, PhD, discuss a unique proprietary temperature standardization technology that is practical for all stages of cell processing and handling. It is currently supporting a Phase IIb clinical trial investigating the efficacy of an immunotherapy treatment for patients with moderate-to-severe refractory Crohn’s disease.

AUTOLOGOUS CELL THERAPIES - Development of Autologous Cell Therapies: Keys to Clinical & Commercial Success April 30, 2013

Ronnda L. Bartel, PhD, Tod Borton, and Brian S. Hampson review how Aastrom Biosciences has developed the innovative processes necessary to reduce risk throughout the manufacturing process. The company is now preparing for future commercialization for its investigational therapy derived from a patient’s own bone marrow stem cells.