Author Archives: Gareth Macdonald

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:…

Cesca and HealthBanks jump on the CAR-TXpress in cell banking JV

Cesca Therapeutics and HealthBanks Biotech say their cell processing tech and banking JV will target CDMOs and immunology researchers. Under the agreement Cesca’s subsidiary ThermoGenesis will grant the newly formed joint venture – to be called ImmuneCyte Life Sciences – an exclusive license to its CAR-TXpress technology. The system is used to isolate blood components in a cGMP compliant manner. According to Cesca it is 16 times more efficient than ficoll gradient centrifugation-based cell processing methods. In addition to offering…

Gene therapy demand drives Cytovance pDNA expansion

Cytovance Biologics has added plasmid DNA (pDNA) production capacity at its Oklahoma City facility citing growing demand from gene therapy developers. The single-use production system is capable of making both critical reagent grade – for research – and cGMP grade pDNA in quantities ranging from 1g to 50g. It can manufacture smaller quantities for R&D. Jesse McCool, Cytovance chief technology officer (CTO), framed the investment as part of the firm’s effort to position itself as a key gene therapy supply…

Zolgensma: Manufacturing questions delay decision in EU and Japan

Novartis has asked the EMA to inspect its Zolgensma plant in San DIego after the agency – and Japan’s PDMA – delayed approval decisions and asked for more details of how the gene therapy is made. Zolgensma is a gene therapy. It is designed to halt progressive spinal muscular atrophy (SMA) – motor neurone loss and muscle wasting – in kids with a defective version of a gene called SMN1. The drug encodes a functional copy of the gene enabling sustained…

Biogen’s services revenues fall; Aducanumab re-emerges

Biogen saw its manufacturing services revenue slide in Q3 following the sale of its plant in Hillerod, Denmark. According to Biogen’s Q3 report the firm’s “other revenues” –those not generated by drug product sales – fell 26% year on year to $110m. CFO Jeff Capello attributed the decline to the divestiture of the firm’s biologics manufacturing in Hillerod facility to Fujifilm. “Total other revenues in the third quarter decreased 26% versus the prior year driven by the decline in our…