Author Archives: Dan Stanton

Ionis pledges to up its RNA game in SMA and elsewhere

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Self-proclaimed pioneer of RNA-targeted medicine Ionis Pharmaceuticals says it is looking to develop an “even better medicine†to Spinraza to treat spinal muscular atrophy (SMA). At its annual meeting of stockholders earlier this month, Ionis Pharmaceuticals spoke about the success of its flagship molecule, Spinraza (nusinersen), an oligonucleotide approved by the US Food and Drug Administration (FDA) in December 2016 for the treatment of SMA. “Spinraza is the standard-of-care for all forms of the disease SMA. It is a medicine…

June 12, 2019

Californian sun and $1.5m investment help ATUM go green

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Switching to renewable energy sources reduces the biomanufacturing industry’s contribution to global warming, saves money and is relatively easy to do, says ATUM. Life sciences services firm ATUM has completed the installation of 26,000 square feet of solar paneling at its production site in Newark, California. The $1.5 million (€1.3 million) project give the site the ability to run on 100% solar power. The decision to go green plays into the founders’ ethos to build a company with a long…

June 12, 2019

Inside Jefferson: $7m bioprocess training institute opens in PA

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The Jefferson Institute for Bioprocessing (JIB) has opened its doors in Pennsylvania. Bioprocess Insider visited to find out how the site, supported by Ireland’s NIBRT and GE Healthcare, will aid the bioprocess industry. In June 2018, plans were laid down for a site in Pennsylvania for an education and training institute to support the staffing gaps in the bioprocessing space. A year on, the Jefferson Institute for Bioprocessing (JIB) has opened, with help from a $7 million (€6.2 million) investment…

June 12, 2019

Servier selects Yposkesi for viral vector supply

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The deal brings Servier access to CDMO Yposkesi’ lentiviral vector production for its Phase I allogeneic CAR-T candidate UCART19. Servier has chosen contract development manufacturing and organization (CDMO) Yposkesi to provide the lentiviral vectors for its candidate UCART19, an off-the-shelf chimeric antigen receptor (CAR) T-cell in trials for haematological malignancies. According to the firm, its selection of fellow French CDMO came “after testing lentiviral vectors from several competitors and comparing the costs,†though financial and timelines details have not been…

June 11, 2019

Pluristem looks to cell cultured cannabinoids

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Pluristem Therapeutics has filed a provisional patent application to use its 3D cell culturing technology to manufacture cannabinoid-producing cells. Pluristem has several candidates in its pipeline based on placenta-derived, mesenchymal-like adherent stromal cells, has inked a recent study agreement with NASA, and is working with Thermo Fisher to address the lack of technologies available to cell therapy manufacturers for the cultivation and processing of allogeneic products. Now the Israeli cell therapy firm is looking to use its cell culture platform…

June 7, 2019

UNSW looks to ‘submarine-like’ microparticles for drug delivery

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Micro-motors developed by the University of New South Wales (UNSW) could respond to variations in biological environments to navigate and attack tumor cells. Findings from the research undertaken at Sydney, Australia-based UNSW have been published in Material Today, under the title ‘Biocatalytic self-propelled submarine-like metal-organic framework microparticles with pH-triggered buoyancy control for directional vertical motion.’ The paper shows evidence of “self-propelled submarine-like microparticles†that carry drugs and use changes in the biological environments and pH to navigate to specific areas…

June 7, 2019

Vaccines the ‘backwaters of the pharma industry’ due to low price expectation

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Historic low prices and the fact they are administered to healthy people means vaccine development plays second fiddle to biologics, according to a panel of experts. At the BPI West event in Santa Clara, California earlier this year, Rahul Singhyi, COO of Takeda vaccines, told delegates that vaccines used to be viewed as “the backwaters of the pharma industry.†Fast forward several months to the BPI Europe event in Vienna, Austria, and Bioprocess Insider asked four more experts within the…

June 5, 2019

Stem cell clinic crackdown continues with FDA letter to R3

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Despite receiving an untitled letter from the US FDA over its promotion of unapproved stem cell therapies, Arizona firm R3 Stem Cell, LLC continues to push its questionable therapies to “vulnerable patients.†The US Food and Drug Administration (FDA) has put Scottsdale, Arizona-based company R3 Stem Cell on notice for marketing unapproved stem cell treatments. In the untitled letter dated May 30, the Agency said R3, through its affiliated clinics, offers unapproved stem cell products for serious conditions including Lyme…

June 4, 2019

Rexgenero adds CMO to speed up cell therapy trials

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Regenerative medicine firm has contracted the German Red Cross Blood Donor Service to expand production of its autologous bone marrow-based cell therapy REX-001. London, UK-headquartered firm Rexgenero’s lead product is REX-001 is in two Phase III trials both of which are in diabetes patients. The firm manufactures the autologous cell therapy from its production site in Seville, Spain, added through its incorporation of Spanish subsidiary Rexgenero Biosciences S.L in 2015. But to increase production and expedite clinical trials, the firm has…

June 4, 2019

PE to boost Vibalogics’ viral vector capabilities

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Private equity firm Ampersand Capital Partners has bought CDMO Vibalogics and intends to expand its capabilities to service the demand for gene therapy services. The price of the German contract development and manufacturing organization (CDMO) has not been disclosed, but Ampersand’s acquisition will help widen Vibalogics’ global reach on the back of increased demand for viral vector and gene therapy services. “Vibalogics can now strengthen and expand the position in both of its home markets, the USA and Europe, as…

June 2, 2019