Therapeutic Class

Get your TOX off: Piramal looks to next generation of ADCs

Non-cytotoxic payloads, immune-stimulating antibody conjugates, and peptide-delivery mechanisms all form part of the new drug-conjugate landscape, says Piramal Pharma Solutions. It has been over 20 years since the first antibody-drug conjugate (ADC) hit the market. However, the sector has only taken off over the past three years with six US FDA approvals tallying the total number of marketed ADCs to 11, the latest being ADC Therapeutics’ Zynlonta (loncastuximab tesirine). Download our ebook ‘ADCs – Evolving Links in the Biopharmaceutical Pipeline’…

Robotic CAR? Cytiva and Multiply team on cell therapy automation

Cytiva has partnered with Multiply Labs to create a fully automated robotic system intended to support commercial-scale cell therapy manufacturing. “Cytiva and Multiply Labs want to develop a robotic system that will automate the manufacturing processes for cell therapies and drastically bring down the cost to do so,” Parker Donner, head of Business Development, Cell and Gene Therapy at Cytiva told BioProcess Insider. “While these therapies have proven to be very effective, the manufacturing workflow is overly reliant on manual…

UPenn gene therapy researchers lease space at Discovery Labs

University of Pennsylvania gene therapy researchers have leased space at Discovery Labs’ facility in King of Prussia in a deal designed to expand vector production capacity. The agreement – financial terms of which have not been disclosed – includes two dedicated floors at Discovery Labs’ campus on Swedeland Road. The leased space will house the Penn Vector Core, which is a full-service viral vector manufacturing operation. At present Penn produces viral vectors for use in gene transfer. It supplies vectors…

eBook: ADCs — Evolving Links in the Biopharmaceutical Pipeline

Antibody–drug conjugate (ADC) developers both old and new are talking about the next generation of drug candidates coming through their pipelines. In April 2021, Zynlonta (loncastuximab tesirine, from ADC Therapeutics) became the eleventh such product to receive approval from the US Food and Drug Administration (FDA). But with dozens of ADC candidates currently in clinical trials, those 11 products represent the tip of the ADC iceberg. In this eBook, Dan Stanton (founding editor of BioProcess Insider) explores ADC production history,…

Thermo teams with UCSF on San Fran cell therapy center

Thermo Fisher Scientific has teamed up with the University of California, San Francisco (UCSF) to set up a cell therapy manufacturing center. The facility – which will be at USCF’s Mission Bay campus in San Francisco – will offer clinical and commercial cGMP cell therapy manufacturing services and technology development support. According to Thermo Fisher, the facility, which is due to open next year, will serve as a central location where customers and UCSF researchers will have access cell therapy systems, reagents,…

Laronde aims to turn cells into drug production facilities using eRNA

Venture capital backed biotech Laronde has created a new type of RNA it claims can be used to create programmable protein therapeutics. The Massachusetts based firm unveiled its “Endless RNA” platform this week, while also confirming it had secured a $50 million investment to support development and an initial pipeline of medicines from Flagship Pioneering. Endless RNA – or eRNA – is based on of long non-coding RNA (lncRNA), which is naturally abundant in circular form within mammalian cells. Unlike…

Podcast: On board the Cell Shuttle with Cellares

Cellares Corporation’s CEO Fabian Gerlinghaus talks about the current limitations in cell therapy production and how, with $82 million in hand, its Cell Shuttle technology could resolve these. Tech firm Cellares Corporation is looking to advance development of its cell therapy manufacturing platform, the Cell Shuttle. Having raised $82 million in its latest funding round, co-founder and CEO Fabian Gerlinghaus spoke about how the Cell Shuttles’ scalable, modular, and automated nature could be a gamechanger in the burgeoning space on…

Allogene and Regenxbio point to inhouse CGT advantage

With facilities set to come online in California and Maryland, Allogene and Regenxbio respectively are the latest advanced therapy firms to laud the advantages of inhouse production. Allogene launched in 2018 with backing from Pfizer and has progressively been developing its AlloCAR T allogeneic, or off-the-shelf, chimeric antigen receptor (CAR) T-cell therapies. Its lead candidate is ALLO-501A looking to move into Phase II studies for Non-Hodgkin Lymphoma later this year. The company hopes to support the trial and beyond through…

Charles River sets sights on cell therapy manufacturing after Cognate buy

US contract research firm Charles River says its expanded manufacturing business will focus mainly on cell therapy production. CEO Jim Foster outlined Charles River’s plan this week, telling analysts the firm’s recent acquisition Cognate BioServices would boost the contract research organization’s (CRO) biologics business. “Cognate gives us the ability, and particularly in combination with HemaCare and Cellero, to provide the cells to do the process development, to do the clinical trial scale up, and ultimately, to provide commercial quantities specifically…

ADC Therapeutics joins conjugate elite with Zynlonta FDA approval

The US FDA has approved Zynlonta (loncastuximab tesirine), the eleventh antibody-drug conjugate and the first for ADC Therapeutics. Zynlonta received the thumbs up from the US Food and Drug Administration (FDA) last week for the treatment of patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The antibody-drug conjugate (ADC) is composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD)-based cytotoxic warhead. PBDs are a class of compounds…