Author Archives: Gareth Macdonald

Antibody–Drug Conjugate News: From BioProcess Insider

The following news items have appeared on the BioProcess Insider site over the past year. Together they indicate the direction in which the ADC sector is moving. BEYOND ADCETRIS — SEATTLE GENETICS AIMS FOR BIG BIOPHARMA STATUS 30 April 2018: Seattle Genetics is building toward a bigger future. For the first quarter 2018, the company’s total revenues grew to US$141 million (€116 million) compared with $109 million in the same period last year. This was attributed to a 36% increase…

Breathing space: Inhalable biologics interest prompts Intertek expansion

Interest in inhaled biologics is increasing says Intertek, which has announced plans to expand its testing facility in Melbourn, near Cambridge. Intertek will double capacity with a new 20,000 square-foot lab kitted out with technologies use to assess inhaled and nasal formulations of large molecule drugs. It also plans to hire 100 employees over the next four years. “As companies are increasingly looking at biologics for non-invasive delivery platforms like inhaled and nasal, there is expected to be an increased…

FDA pledges to support cell and gene therapy manufacturing innovation

Manufacturers aiming to follow Yescarta and Kymriah to market can count on FDA support after the agency said it will help cell and gene therapy firms adopt better production methods. A US Food and Drug Administration (FDA) spokesman told Bioprocess Insider the agency’s emerging technology team has been tasked with working with cell and gene therapy firms to “identify innovative approaches for efficient product manufacturing.” The move is part of a wider FDA effort to support modernization of drug manufacturing…

PureTech cites Big Pharma tech partnerships as 2018 highlights

PureTech Health says delivery technology deal with Roche was key part of its financial performance in 2018. The US biotech made the comments last week. It explained that its revenue growth for the year – $20.7 million (€18.5 million), up from $2.5 million in 2017 – was due in part to the Roche accord inked last July. CEO Daphne Zohar also predicted the deal will shape future performance. “We are now engaged in collaborative research with Roche to advance our…

Lonza goes live with microbiome CMO joint venture

Lonza says GMP know-how and drug delivery tech are core to its live biotherapeutics joint-venture formed with Chr. Hansen. The Swiss contractor and Danish bioscience firm set up the contract manufacturing organization (CMO) in April, citing biopharma interest as the driver. Live biotherapeutic products (LBPs), as the name suggests, are living organisms. Unlike probiotics used to try to improve general health, LBPs are drugs intended to treat or cure disease. “LBPs are regulated as drugs and have to go through…

GeoVax targets WHO goal with multi antigen malaria vaccine

GeoVax Labs says the malaria vaccine it is developing with Leidos could achieve efficacy levels called for by the WHO. US firms GeoVax and Leidos agreed to develop a P. falciparum vaccine in March, expanding on an R&D partnership they formed last November. Under the deal, GeoVax will make a vaccine able to deliver DNA coding for parasite proteins. Cells ‘infected’ by the vaccine will express the proteins, provoking an immune response. Leidos spokeswoman Erin Tindell told us the DNA…

AZ inks $6.9bn ADC deal with Daiichi Sankyo

AstraZeneca and Daiichi Sankyo will co-develop cancer antibody-drug conjugate (ADC) DS-8201 in a deal worth up to $6.9 billion. AstraZeneca will pay $1.35 billion (€1.2 billion) upfront for rights to DS-8201 (trastuzumab deruxtecan). The UK firm will pay a further $5.5 billion if the drug achieves regulatory and sales targets. Under the agreement, Daiichi will manufacture DS-8201. AstraZeneca will help develop and sell the drug worldwide, except in Japan where Daiichi has exclusive rights. Spokesman Rob Skelding told us AstraZeneca’s…