Author Archives: BPI Staff

Cellectis selects Lonza for off-the-shelf CAR-T manufacture

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CDMO Lonza will make clinical batches of an allogeneic CAR-T cell candidate from its facility in the Netherlands for French firm Cellectis. Cellectis has a range of ‘UCART’ off-the-shelf chimeric antigen receptor (CAR) T-cell therapies in development for hematological malignancies, based on its TALEN gene-editing technology. To support this, the French biopharma has selected Swiss contract development and manufacturing organization (CDMO) Lonza to supply clinical materials from its facility in Geleen, added to its cell and gene therapy network through…

October 4, 2019

Astellas ups MA cell therapy presence with $13m incubator investments

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The support of two biotech incubators operated by LabCentral is the latest investment by Astellas Pharma in the Massachusetts cell and gene therapy landscape. Of the $13 million (€11.9 million) investment, $12.5 million will be pumped into a facility being developed by LabCentral in Cambridge, Massachusetts, set to house a lab space for start-up companies to conduct process development studies and a non-GMP pilot plant for cell and gene therapies. The rest of the investment will see Astellas become a…

October 2, 2019

Bavarian Nordic gets FDA tick for monkeypox vaccine

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Jynneos has become the first vaccine to be approved for non-replicating smallpox in the US and monkeypox in the world. The US Food and Drug Administration (FDA) has given Danish drugmaker the go ahead to manufacture and supply the liquid-frozen suspension of its vaccine Jynneos for smallpox and monkeypox in adults aged 18 years and over. The approval is “the culmination of a fifteen-year partnership that started with a call from the NIH [National Institutes of Health] for a safer…

September 26, 2019

GSK pays Immutep on advancement of Ab for Ulcerative Colitis

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The first patients have been dosed in a Phase II trial for GSK2831781, GSK’s ulcerative colitis candidate based on Immutep’s depleting anti-LAG antibody technology. In 2010, GlaxoSmithKline (GSK) licensed ImmuTune-IMP731, a therapeutic antibody for the treatment of autoimmune diseases, from Immutep in a deal that included milestone payments of £64 million ($80 million). This week, GSK is paying out £4 million of this due to the first patient being dosed in GSK’s Phase II clinical trial evaluating the candidate –…

September 25, 2019

BWB startup pitch: Biopharm America’s got talent

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Secure health data services firm Bowhead Health has won a startup pitch competition run jointly by the Xcelerate and Biopharm America conferences. Bioprocess Insider brought live commentary of the event at Biotech Week Boston. Presided over by seasoned journalist Mike Ward from the EBD Group, twelve participants – well, eleven as one didn’t show – pitched their startup healthcare focused companies in four-minute slots on stage at Biotech Week Boston. Last week’s event, a collaboration between Xconomy’s Xcelerate conference and…

September 17, 2019

Lonza to make ‘NET’ antibody for Citryll

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Citryll BV has partnered with CDMO Lonza to help develop and supply final drug product for its Neutrophil Extracellular Trap (NET) biology targeting antibody candidate. Under terms of the deal, financials of which have not been divulged, Swiss contract development and manufacturing organization (CDMO) Lonza will provide Dutch biotech firm Citryll in silico preclinical services used to assess manufacturability and immunogenicity, and final drug product in finished format for clinical material. Citryll’s candidate CIT-013 is a tACPA therapeutic antibody targeting…

September 13, 2019

Berkeley Lights takes Beacon workflow tech to China

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Berkeley Lights has opened an office in Shanghai to expand the reach of its automated biological workflow platform for cell line development and antibody discovery. The office, located in Pudong, Shanghai, will provide Berkeley Lights regional marketing and pre-sales service in China and the Asia Pacific (APAC) region. The decision to open an office in the region reflects the importance of the Chinese market for the bioprocessing space, said Yue Geng, head of Asia Pacific at Berkeley Lights. “China represents…

September 9, 2019

Batavia selects CHO platform for Zika Ab on the Horizon

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A collaboration led by Batavia Biosciences will use Horizon Discovery’s CHO cell technology in the development of an antibody against Zika. Batavia Biosciences, working with Vanderbilt University Medical Center (VUMC) and IDBiologics, is looking to develop a therapy based on a Zika virus neutralizing antibody that was discovered three years ago. Accessing Horizon Discovery’s GS knockout Chinese hamster ovary (CHO) K1 cell line expression system will allow the development of high yield antibody-expressing cell lines, Batavia CEO Menzo Havenga told…

September 4, 2019

Celyad going to clinic with tweaked CAR-T manufacturing platform

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Celyad expects to treat the first patients with its autologous CAR-T therapy CYAD-01 using the updated manufacturing process by the end of September. CYAD-01 is an autologous chimeric antigen receptor (CAR) T-cell therapy in development by Celyad for hematological malignancies and solid tumors. The immunotherapy has the ability to bind to eight different ligands that are naturally expressed by cancer cells. In July, the firm announced regulators accepted a proposal to change the candidate’s manufacturing process to use its proprietary…

September 2, 2019

Lineage granted stem cell production patent for cancer vax

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The patent validates a system for production of antigen presenting dendritic cells from human embryonic stem cells (hESCs), used in Lineage Cell Therapeutics’ cancer immunotherapy program VAC2. The United States Patent and Trademark Office (USPTO) issued Patent No. 10,344,262, entitled ‘Differentiation of primate pluripotent stem cells to hematopoietic lineage cells,’ to Lineage Cell Therapeutics in July. The patent was filed by Asterias Biotherapeutics in February 2017. Asterias was acquired by clinical-stage biotech BioTime in March 2019, and since then BioTime…

September 2, 2019