Author Archives: Gareth Macdonald

eBook: The Post-Pandemic Supply Chain

Supply chains felt the full force of COVID-19, leading to industry rapidly adopting new protocols. As a post-pandemic world emerges, this ebook looks at both how the lessons learned have become standard among biomanufacturers and how rising macroeconomic threats including inflation and climate change continue to force supply chains to evolve. Fill out the form below to read the full eBook on supply chains now.    

Regeneron probing bispecific Abs with eye on future cancer therapies

Bispecific antibodies that mirror the natural biology of immune T-cells are the key to a new generation of cancer therapies, according to Regeneron.  Antibodies bind specific antigens – molecular targets such as proteins expressed on the surface of tumors. Bispecific antibodies, as the name suggests, can bind two antigens at the same time. This binding ability means they have significant potential as therapies according to Eric Smith, senior director of bispecific antibodies at Regeneron, who shared details of the firm’s…

Cell and gene therapy sector needs purpose-built PAT

Process analytical technology (PAT) can help cell and gene therapy developers better understand and control product manufacture. But, to date, use has been limited according to researchers, who say the sector needs more purpose-built monitoring technologies. The conclusion comes from a study looking at how machine learning and metabolic modelling can be used to use process analytical technology in cell and gene therapy manufacturing. According to the authors “Process analytical technology (PAT) has demonstrated huge potential to enable the development…

Industry turns to continuous improvement to improve cell therapy manufacturing

The industrial concept “continuous improvement” is helping cell therapy developers and their CDMOs make production processes more efficient. Continuous improvement emerged in the mid-1980s from the Japanese idea of Kaizen – “good change” – which is the practice of reassessing and tweaking processes on a continual basis in real time. The approach has been used in various industries to optimize complex processes with maintenance monitoring in the automotive industry being one of the most widely cited examples. Cell therapy firms…

Kite and Arcellx partner to advance blood cancer cell therapy

Fresh from announcing its acquisition of Tmunity, Kite Pharma is buying a 50% stake in a cancer drug being developed by US biotech Arcellx. The Gilead unit will pay $225 million and cash and make a $100 million equity investment in Arcellx for a half share in CART-ddBCMA, a candidate treatment for patients with relapsed or refractory multiple myeloma. Currently in Phase II clinical development, CART-ddBCMA is made of autologous T cells that have been modified using Arcellx’s novel D-Domain…

CDMO deal drivers in 2022: Advanced therapies, RNA, and capacity

CDMO sector M&A activity continued apace in 2022 with contractors making deals to cater for evolving drug industry demands – particularly mRNA-related production capabilities – to add capacity and to tap regional markets. The pharmaceutical contract manufacturing sector is highly fragmented yadda, yadda, yadda… Consolidation is an acknowledged growth strategy blah, blah, blah… Deal making has been, and always will be, a defining characteristic of the CDMO space. The difference this year is that while some contractors have bought for…

Vector suppliers need to improve production processes

Gene therapy developers need access to high quality viral vectors and to meet this need suppliers need to optimize manufacturing processes, says Genemagic Biosciences’ CEO, Jingmin Zhou. Viral vectors are empty virus particles that can be used to deliver selected sections of genetic material into target cells. They are a key component of modern molecular biology and have been used in everything from cell line development through to crop engineering. In addition, viral vectors are vital to the cell and…

Cell Therapy — Supply Chain Discussions

The 2017 approval of Kymriah (tisagenlecleucel) has paved the way for other cell therapy products to reach the patients who need them. Each passing year promises to open the regulatory floodgates to more product approvals, but technical and manufacturing issues continue to keep initially high expectations from being realized. One barrier is supply chain complexity, especially for the subset of autologous cell therapies. This eBook features expert commentary from Be The Match BioTherapies, a company providing more than 50 product…

Cell and gene sector still facing capacity crunch, say experts

Cell and gene therapy firms still face a “capacity crunch” – a lack of manufacturing space, technology, or raw materials that delay projects – according to experts, who say disruption caused by COVID-19 and the surge in R&D as the pandemic ebbs have made the situation worse. In 2017, the New York Times suggested a lack global capacity for the production of viral vectors was slowing the development of cell and gene therapies. The thrust of the article was that…

Sino Biological to build manufacturing and CRO services unit in Texas

Shenzhen stock exchange-listed Sino Biological has leased land to build a bioprocessing center and CRO in Levit Green, Houston. The new facility – which will be at a site leased from the real estate investment, development, and property manager Hines – will focus on product manufacture and the provision of contract research services. The aim is to provide drug industry sponsors and academic researchers working in the region with access to “bioreagents and CRO services” says Rob Burgess, Sino Biological’s chief business…