Author Archives: BPI Staff

CellGenix: Serum-free medium offers faster T-cell therapy manufacturing

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Freiburg, Germany-based CellGenix says its T-cell medium – CellGenix TCM – offers a serum-free and xeno-free alternative for rapid expansion of functional human T-cells. Due to stable glutamine in the formulation, the medium is ready-to-use for T-cell cultures without the need for supplementation with human serum or glutamine. Many current T-cell therapy protocols rely on the addition of human serum. Eliminating the use of human serum will reduce the failure rate in your manufacturing process due to the high lot-to-lot…

October 6, 2020

Trump’s ‘reckless’ drug pricing Executive Order threatens innovation, BIO chief

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The US is doing more in the COVID-19 space than anywhere in the world due to the strength of its innovative ecosystem, says Michelle McMurry-Heath, head of trade group BIO. But such innovation is under threat due to “reckless†orders coming out of the White House. As part of an exclusive interview filmed for Xconomy’s Xcelerate’s Keynote Series at Biotech Week Boston next week, Michelle McMurry-Heath, president & CEO of life sciences advocacy group Biotechnology Innovation Organization (BIO), criticized Executive…

September 17, 2020

Advanced therapy news: RoslinCT, Marker, Freeline to establish facilities

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As the surge in cell and gene therapies entering and progressing through the clinic continues, we highlight manufacturing plans from Marker Therapeutics, Freeline, and CDMO RoslinCT. First up in this cGMP manufacturing investment roundup is clinical-stage immuno-oncology company Marker Therapeutics, which has announced plans to lease a facility in Houston, Texas The 48,500 square-foot plant, expected to be operational in 2021, will support the firm’s T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. “We are…

July 6, 2020

Repligen boosting single-use portfolio with Engineered Molding Technology buy

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Repligen will add silicone single-use consumables and components for bioprocessing functions through the addition of Engineered Molding Technology (EMT). The size of the deal has not been divulged, but Repligen will expand its single-use filtration and chromatography system component portfolio with custom molded and over-molded connectors and silicone tubing products. “The acquisition of EMT expands our line of single-use ProConne® flow paths, streamlines our supply chain for ATF, and gives us more flexibility as we scale and expand our single-use…

July 1, 2020

News of note: Sanofi’s €610 million vaccine boost

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Sanofi will build a production site and an R&D facility near Lyon in efforts to make homeland France the center of its global vaccine efforts. The plant in Neuville sur Saône, north of Lyon, France, represents an investment of €490 million ($550 million). It will be modular in its design and dedicated to vaccine production and is being set up to respond to future epidemics. The R&D center in Marcy-l’Etoile, west of Lyon, represents €120 million and will look to…

June 22, 2020

In brief: Single-use manufacturing begins at Meissner’s Irish plant

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Meissner says the production of single-use systems has begun from its newly-established site in County Mayo, Ireland. The filtration firm announced in February 2019 plans to establish a production site in Castlebar, Ireland to support demand for its single-use products form the biopharma industry. Sixteen months on and the facility has begun supplying the space after a 10,000 square-foot ISO class 7 cleanroom was completed in mid-April. With the current COVID-19 crisis still ongoing, there was no ribbon-cutting ceremony. “This…

May 29, 2020

In brief: GSK inks $231m ‘flexible’ deal with Samsung BioLogics

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GSK says the eight-year agreement with the Korean CDMO brings additional and flexible capacity to manufacture its innovative biopharmaceutical therapies. UK-headquartered pharma giant GlaxoSmithKline (GSK) has an extensive manufacturing network to support its biologics product portfolio but has turned to contract development and manufacturing organization (CDMO) Samsung BioLogics to secure capacity for future needs. The deal will see Samsung Biologics provide GSK with additional capacity for large-scale biomanufacturing from its site in Incheon, South Korea. The capacity will be flexible…

May 27, 2020

Viral vector vaccines and a nucleotide: Merck enters the COVID game

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A triumvirate of deals, including the acquisition of a firm that uses the measles virus as a carrier for vaccines, sees Merck & Co. jumpstart its COVID-19 efforts. The first of the three announcements – which all came on the same day – will see Merck & Co. acquire vaccine developer Themis. The private Austrian firm is already working with Merck to develop vaccine candidates using its viral vector platform. The technology, developed at the Institut Pasteur and licensed to…

May 27, 2020

Fujifilm licenses AAV vector tech to speed gene therapy production

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CDMO Fujifilm Diosynth Biotechnologies (FDB) says partnering with OXGENE could reduce the lead time of its customers’ gene therapy projects by up to 25%. The technology, licensed from UK-based OXGENE for an undisclosed fee, consists of Helper, Rep/Cap and Gene of Interest plasmids, used in combination with a clonal suspension a HEK293 cell line. The AAV system is expected to reduce the length of the supply chain gene therapy customers, according to contract development and manufacturing organization (CDMO) FDB, with…

April 28, 2020

In brief: CDMO Cobra collaborates on coronavirus vaccine

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Cobra Biologics and the Karolinska Institutet with EU Horizon 2020 emergency funding in hand have teamed to develop a DNA vaccine against COVID-19. Contract development and manufacturing organization (CDMO) Cobra Biologics and Swedish medical university form part of a consortium called OPENCORONA aimed at developing and manufacturing a DNA vaccine against the novel coronavirus (COVID-19) set to be delivered to patient muscle to generate  a viral antigen on which the immune system then reacts. The consortium, which also includes Karolinska…

April 2, 2020