Author Archives: Gareth Macdonald

Back to business? Demand for trials returning, says Icon

Icon says demand is recovering with bookings for its own services as well as those of soon-to-be acquired PRA continuing to climb in the second quarter. The Dublin, Ireland headquartered contract research organization (CRO) saw bookings increased 27% in the first quarter, versus the first three months of 2020, with book-to-bill ratio – roughly the value of new contracts divided by revenue – of 1.28. And the momentum has continued, according to CFO Brendan Brennan who spoke at Jefferies’ Healthcare…

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…

Engineering Alternatives: Modern Technology Enables Expression System Developers to Think Beyond CHO Cells

Major biopharmaceutical companies are teaming up with academics and the Bill & Melinda Gates Foundation to develop new biomanufacturing cell lines and methods. The project — known as the AltHost Consortium — is exploring innovative ways to produce biologics and vaccines for clinical usage in diseases from diabetes to cancer. Lead researcher J. Christopher Love at the Massachusetts Institute of Technology (MIT) likens this precompetitive, open-access collaboration to the early days of the biopharmaceutical industry. “When biomanufacturing first emerged as…

Bluebird welcomes CHMP nod for CALD gene therapy

Bluebird Bio says Skysona – a treatment for the neurological disease CALD – is a step closer after a thumbs-up from EMA reviewers. The European Medecines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the therapy and issued an approval recommendation last week. The CHMP said the advice was based on a study in which Skysona (elivaldogene autotemcel, formerly Lenti-D) preserved motor function and communication ability and improved survival in 90% of patients…

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,…

Canada pays $164 million to add Resilience to pandemic prep effort

Canada has called on Resilience Biotechnologies to boost local COVID-19 shot capacity. The Canadian Government has given contract development manufacturing organization (CDMO) Resilience Biotechnologies $164 million to modernize its recently acquired Ontario plant as part of a wider pandemic preparedness effort. The CDMO – which is part of San Diego, US based headquartered firm National Resilience – announced further details this week. It said the investment will increase manufacturing capacity for vaccines and therapeutics, including those based on mRNA that…

Charles River to boost CDMO offering through $300m Vigene acquisition

Charles River Labs plans to buy gene-therapy focused CDMO Vigene Biosciences for $300 million, further expanding its presence in the manufacturing space. The deal – which values Vigene at $292.5 million – will add viral vector-based gene delivery solutions to the contract research organization’s (CRO) expanding contract manufacturing offering. The transaction is expected to close in the beginning of the third quarter. Charles River CEO James Foster said the purchase would “expand our comprehensive cell and gene therapy portfolio to…

Merck: COVID-related work helped German firm grow revs in Q1

COVID-19 will continue to drive growth according to Merck KGaA, which says demand from vaccine makers helped its life science business revenue grow 20.4% to € 2.1 billion in Q1. The German drug and processing tech firm unveiled its results for the first quarter this week, explaining that group sales increased 6% to € 4.6 billion ($5.6 billion) “mainly thanks to the high organic growth of the Life Science business.” Merck’s process solutions business – the part of the life sciences…

CDMOs need to invest in innovation to make complex meds, says Resilience CEO

Biopharma CDMOs need to rethink production according to Resilience CEO Rahul Singhvi, who says industry must learn to make a new generation of complex products. Advances in biological science in recent years are helping the biopharmaceutical industry to start unlocking the potential of cell and gene therapies. For example, in the past few months the US FDA has approved two cell based cancer meds – Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel) – further underlining the cell therapy sector’s potential.…

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…