Author Archives: Gareth Macdonald

Purolite resin booming on biopharma uptake and ‘major’ regulatory milestone

The US FDA has approved a manufacturing process using a Purolite Praesto resin for the first time. Purolite says Janssen, Celgene and Biogen are among the firms working with its Praesto range of mAb capture resins. The separation tech firm told Bioprocess Insider about demand for its products last week, explaining that “Praesto resins are currently implemented into over 170 ongoing pre-clinical to Phase III projects at facilities across the globe. “This is a mix of standard and custom design…

Thermogenesis cell preservation tech to drive CAR-T cancer trial eligibility

Rebranded Thermogenesis used its quarterly call to outline plan to target unmet tech and manufacturing needs in the CAR-T sector. The firm – known until November 1 as Cesca Therapeutics – will pitch its cell processing tools and its new services joint venture – Immunecyte – as a way to help reduce CAR-T manufacturing, storage and distribution costs. CEO Chris Xu told analysts on Thermogenesis’ third quarter call that Immunecyte – formed with Healthbanks Biotech last month – would be…

WuXi on board for Tychan’s yellow fever mAb

Wuxi Biologics will manufacture supplies of Tychan’s developmental yellow fever biologic for clinical trials. The drug in question – known as TY014 – is a first-in-class monoclonal antibody. It targets the envelope (E) protein on the surface of the yellow fever virus and prevents replication by limiting fusion to host cells. Earlier this month Tychan announced it had successfully completed Phase IA/IB safety studies. The firm also said it received regulatory approval to test the drug in a field study…

Avantor partners with NIBRT to take on biopharma bottlenecks

Avantor has teamed up with Ireland’s National Institute for Bioprocessing Research and Training (NIBRT) to develop solutions for “bottlenecks” that increase the cost and time it takes to make biopharmaceuticals. The collaboration – financial terms of which were not provided – will see Avantor install in-line dilution systems at NIBRT’s facility in Dublin, Ireland. The idea is to provide technicians with hands-on experience of the technology according to Killian O’Driscoll, NIBRT director of projects. “The in-line dilution technology will be…

Biolife buys CBS, turns focus on integrating cold-chain acquisitions

Biolife Solutions says cold storage tech firm Custom Biogenic Systems (CBS) is likely to be its last acquisition for a while as integration will be the focus in 2020. The US cell and gene therapy tool firm announced the deal this week, citing CBS’ portfolio of liquid nitrogen lab freezers and cryogenic equipment as well as its design and manufacturing capabilities as motivations. CBS CEO, founder, and sole shareholder John Brothers received $11 million (€10 million) in cash and $4…

German plant fastest option to make approved Ebola vaccine, says Merck

Merck & Co expects to complete production of the first batches of Ervebo – its newly EC-licensed Ebola vaccine – at its Burgwedel plant by late 2020. The European Commission (EC) granted Ervebo conditional marketing authorization for the active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus this week. The decision was based on data submitted for accelerated assessment in March. Merck – which is known as…

AGC Bio to plough $18m in US and EU facilities

CDMO AGC Biologics will invest 2 billion Yen ($18.4 million) to increase biopharmaceutical production capacity at facilities in the US and Europe. The plan will see the contract development and manufacturing organization (CDMO) add a 500-liter bioreactor for mammalian cell cultures at its facility in Seattle in the US. The firm said “this will serve better, pharmaceuticals companies with biopharmaceuticals at the earlier stages of development and clinical trials.” It will also install a purification line at its manufacturing plant…

Pfizer unveils biosimilar launch plans and shares view on US market

Pfizer set out a busy programme of biosimilar launches in its Q3 call and shared its thoughts on the “rebate trough” and other challenges facing the US market. First the numbers. Pfizer finished the three months to the end of September with income of $7.7 billion (€7 billion) – up 87% on the year earlier quarter – and revenue of $12.7 billion, which is down 5% year-on-year. The revenue decline was due to Pfizer’s decision to merge its consumer unit with GSK’s…

From Mylotarg to Polivy: Ebbs and flows, successes and woes of ADCs

Interest in antibody drug conjugates (ADC) is surging with more combined MAb and warhead candidates entering clinical trials than ever before. The biopharmaceutical industry has had a difficult few years with ADCs. There have been successes like Besponsa (inotuzumab ozogamicin) – which Pfizer cited as a driver in 2018 – and Roche and Seattle Genetics’ Polivy (polatuzumab vedotin-piiq) which won fast-track approval in the US this year. Likewise, Kadcyla (trastuzumab emtansine) – also made by Roche – has been cleared…

Avacta teams with ADC Therapeutics on Affimer conjugates

Avacta Group and cancer drug developer ADC Therapeutics SA have entered into a collaboration agreement. The partnership – financial terms of which were not made public – will develop drugs combining ADC Therapeutics’ pyrrolobenzodiazepine-based cytotoxic warheads with Avacta’s Affimer targeting platform. ADC Therapeutics will cover all Avacta’s costs during the project. The firm also has the right to obtain exclusive licenses to the Affimer proteins for clinical development and commercialization. Matt Vincent, Avacta’s VP of Therapeutics Business Development, told us:…