Author Archives: Dan Stanton

CDMO Aldevron add 1,000L microbial capacity in Madison

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The continuity of supply chain from research grade to GMP is a differentiator for Aldevron, the firm says as it expands its capabilities in Wisconsin. Contract development and manufacturing organization (CDMO) Aldevron has acquired an existing biomanufacturing plant located in the University of Wisconsin Research Park in Madison. Tom Foti, VP and general manager of Aldevron, did not disclose to Bioprocess Insider from which company the CDMO acquired the $8 million purpose-built plant, but said the 1,000 L E. coli…

May 6, 2019

Gilead lets Kite fly solo to compete in competitive CAR-T space

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Giving cell therapy unit Kite autonomy will “foster agility, innovation and entrepreneurialism,†says recently appointed Gilead CEO Daniel O’Day. Gilead Sciences entered into the advanced therapy space in August 2017 through the $11.9 billion (€10.6 billion) acquisition of Kite. Just weeks later, the firm saw regulatory success with Yescarta (axicabtagene ciloleucel), which became the second chimeric antigen receptor (CAR) T-cell therapy to be commercialized in the US. Close to two years on, the firm has announced it intends to run…

May 6, 2019

Alector inks strategic deal with Lonza for early-phase candidates

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The changing needs of biopharma have driven some customers towards more strategic development and manufacturing partnerships says Lonza, which has inked such a deal with Alector. The agreement, financials of which have not been divulged, sees biotech Alector secure manufacturing capacity for two of its Phase I neurodegeneration drug candidates at contract development and manufacturing organization (CDMO) Lonza’s site in Visp, Switzerland. Alector has seven immuno-neurology candidates in development. The deal makes use of Lonza’s Ibex Solutions service, launched in July…

May 6, 2019

Repligen to buy analytics firm C Technologies for $240m

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Repligen Corporation will expand its bioprocessing services into the process analytics space through the acquisition of C Technologies. The deal, set to close in the next few weeks, sees Repligen add Bridgewater, New Jersey-based spectroscopy firm C Technologies to its bioprocess services. The $240 million (€214 million) deal is comprised of $192 million in cash plus $48 million in Repligen common stock. Repligen has focused over the last few years on broadening out its bioprocess portfolio. While it still boasts…

May 3, 2019

AAV, easy as M-A-b? CEVEC fundraiser to scale-up production

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Germany’s CEVEC claims it can produce adeno-associated viral (AAV) vectors as easily as monoclonal antibodies (MAbs), and has raised funds to expand and commercialize its production platform. While the total raised from new and existing investors in the Series D financing has not been disclosed, Cologne, Germany-based CEVEC says it will be used to advance its CAP GT-based stable AAV vector production platform and move it towards commercialization. As more gene therapies enter the clinic, there is high demand for…

May 1, 2019

Seattle Genetics in ‘good shape’ after restoring Adcetris inventory

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After suffering an $18 million inventory write off, Seattle Genetics says its business as usual for the manufacturing of its lead antibody-drug conjugate (ADC) Adcetris. In its fourth quarter 2018, Seattle Genetics reported an increase in its cost of sales attributed to an $18.1 million (€16.2 million) inventory write-off related to in-process production that did not meet manufacturing specifications and did not impact availability of product supply required to meet demand for its ADC product Adcetris (brentuximab vedotin). Three months…

May 1, 2019

STC opens GMP biologics plant, eyes commercial and gene therapies

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Self-proclaimed ‘boutique CDMO’ STC Biologics has begun initial runs from its newly constructed single-use mammalian plant in Newton, Massachusetts. Contract development and manufacturing organization (CDMO) STC Biologics has undertaken its initial master cell bank (MCB) and three drug substance production runs at its new 3,500 square-foot facility, close to Cambridge, Massachusetts. The plant, which could create up to 30 jobs, brings Good Manufacturing Practice (GMP) manufacturing capabilities to the firm at a 500 L bioreactor scale, expandable to 1,000 L.…

April 30, 2019

Success for Bioepis as FDA approves a second Enbrel biosimilar

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The US Food and Drug Administration (FDA) has approved a second biosimilar of Amgen’s Enbrel (etanercept), Samsung Bioepis’s Eticovo. Korea’s Samsung Bioepis has seen regulatory approval for its etanercept biosimilar in numerous markets, including Korea, Europe, Australia, Canada, Brazil, Switzerland and Israel. Now the firm has had the molecule approved in the US under the brand name Eticovo. This is the second biosimilar of Amgen’s autoimmune disease drug Enbrel to be approved by the FDA. In August 2016, Sandoz received…

April 29, 2019

Lilly inks potential $440m antibody oligo conjugate deal

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Eli Lilly has teamed with Avidity Biosciences for the development of a new class of RNA-based drugs, antibody oligonucleotide conjugates (AOCs). The deal sees Big Biopharma firm Eli Lilly pay Avidity Biosciences $20 million (€18 million) upfront and invest a further $15 million into the L Jolla, California-based company. Depending on development, regulatory and commercialization milestones, Avidity could receive a further $405 million. Lilly hopes to use Avidity’s AOC tech platform to generate “new therapeutic targets in disease areas that…

April 26, 2019

Thermo Fisher allots $125m to expand CDMO buy Brammer

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The gene therapy space is growing at an annual rate higher than 25% says Thermo Fisher, which recently agreed to buy CDMO Brammer Bio for $1.7 billion. Thermo Fisher announced last month the agreement to buy contract development and manufacturing organization (CDMO) for $1.7 billion (€1.5 billion), propelling the life sciences services firm into the gene therapy production space. While the deal has not yet closed (expected by end of Q2 2019), Thermo Fisher said on its first quarter financials…

April 26, 2019