Therapeutic Class Archives - Page 27 of 53 - BioProcess InternationalBioProcess International

Bio-Techne confirms $50m reagents plant to support CGTs

Bio-Techne will build a 50,000 square-foot plant in Minnesota with an initial capacity of $140 million of E. coli-derived recombinant proteins to support cell and gene therapy developers. After months of talk, life sciences services and consumables firm Bio-Techne has laid concrete plans to build a facility in St Paul, Minnesota to produce GMP reagent proteins for use in cell and gene therapy applications. “The facility is expected to go through qualifications in approximately one year, with commercial sales expected…

Gene therapy demand drives Cytovance pDNA expansion

by Gareth Macdonald

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

by Gareth Macdonald

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

by Gareth Macdonald

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…

Glenmark takes bi-specific stance in Ichnos spin-out

by Gareth Macdonald

Glenmark spin-out Ichnos Sciences wants its pipeline of biologic and small molecule drug candidates to be generating clinical data within two years. New Jersey Ichnos announced its plan this week to coincide with the official launch of the company. It said it will progress its most advanced assets – the cancer drugs GBR 1302 and GBR 1342, the autoimmune disease MAb GBR 830, and the non-opioid pain meds GRC 27864 and GRC 17536 – through trials by 2021. Biologics The…

CAR-T at a crossroad as industry looks to allogeneic

by BPI Staff

As cell therapies move through the clinic towards commercialization, respondents to a KNect365 industry survey are beginning to look to allogeneic – or off-the-shelf – products as the next big thing. Almost 200 people contributed to the Cell Therapy Analytics Report from KNect365, revealing their current position within the burgeoning cell and gene therapy space and offering up their thoughts and predictions for the future. The majority worked within companies developing oncology products, and the largest group – 41% –…

J&J downgrades biosimilar threat as Q3 pulls in $10bn+ in pharma sales

by Dan Stanton

J&J reported its sixth consecutive quarter with sales above $10 billion in its pharmaceutical division and has lowered its biosimilar headwind forecast to $2 billion. For the third quarter 2019, Johnson & Johnson (J&J) reported sales across all its units of $20.7 billion (€18.8 billion). Its pharmaceutical division pulled in roughly half of the total, $10.8 billion, up 5.1% on the same quarter last year. “This was our sixth consecutive quarter with sales above $10 billion,” Jennifer Taubert, EVP and…

Novo Nordisk and bluebird to develop ‘once and done’ hemophilia gene therapy

by Dan Stanton

The three-year collaboration will use bluebird bio’s mRNA-based megaTAL gene editing technology to develop a one-off therapy for patients with hemophilia. Novo Nordisk has had a longstanding focus on the hemophilia space. The Danish drugmaker has marketed several replacement factors for hemophilia patients and has a monoclonal antibody in Phase II studies: Concizumab, a Tissue Factor Pathway Inhibitor (TFPI) intended for bleeding prevention after subcutaneous administration. But a partnership announced this week with regenerative medicine firm bluebird bio will look…

Novartis supply-ready for approved wet AMD antibody fragment

by Dan Stanton

Novartis says it is confident in its ability to supply Beovu (brolucizumab) after the single-chain antibody fragment received US FDA approval for treating wet AMD. The US Food and Drug Administration (FDA) this week approved Novartis’ anti-VEGF product Beovu for the treatment of patients with wet age-related macular degeneration (AMD) on a three-month dosing interval. A Novartis spokesperson did not divulge where the antibody fragment is made but told this publication the firm is confident in its ability to meet…

‘Unprecedented’ HPV vaccine demand to fuel more Merck capacity investments

by Dan Stanton

Having recently invested over $1.6 billion in its network, Merck says it is committed to further expand the supply of its HPV vaccines as worldwide demand continues to spiral. Speaking at the at Morgan Stanley 17th Annual Global Healthcare Conference last month, Roger Perlmutter, EVP and president of Merck Research Laboratories, said human papillomavirus (HPV) vaccines Gardasil and Gardasil 9 were the products that have the dominant near-term commercial potential for his firm. But a lack of manufacturing capacity at…