Author Archives: Dan Stanton

Sartorius: $36m WaterSep buy to further boost filtration ambition

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Sartorius will bolster its downstream offering by adding hollow‑fiber membrane manufacturer WaterSep BioSeparations. The deal comes a month after Sartorius closed its €360 million acquisition of BIA Separations, Bioprocess vendor Sartorius Stedim Biotech announced this week it will pay $27 million for Marlborough, Massachusetts-based purification firm WaterSep BioSeparations, with a further $9 million to be paid depending on a defined sales revenue growth by 2023. WaterSep makes hollow-fiber membrane devices and pre-sterilized assemblies for upstream and downstream biopharmaceutical applications. “The…

December 11, 2020

BMS hit by FDA 483 with 6 observations at Washington CAR-T plant

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The Form 483 is a further blow to the potential approval of Bristol-Myers Squibb’s lymphoma CAR-T candidate liso-cel, made at the Bothell, Washington facility. The form comes after the US Food and Drug Administration (FDA) visited the facility between October 7 and 16 and lists six heavily redacted observations made about manufacturing processes. These include failures in reviewing any unexplained discrepancies and questions around the reliability of Certificates of Analysis (COAs) from third-party vendors; problems with written records of investigations…

December 10, 2020

MilliporeSigma accelerates $47m expansions on back of COVID surge

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MilliporeSigma has expedited planned capacity expansions at sites in Massachusetts and New Hampshire after seeing a surge in demand for bioprocess equipment from coronavirus therapy and vaccine developers. The Jaffray, New Hampshire facility manufactures single-use components and filtration equipment for biopharma manufacturers. Having added 38,500 square feet of production space last year, MilliporeSigma is now moving forward with a $22 million 25,000 square-foot expansion, adding new production lines and equipment. Concurrently in Danvers, Massachusetts, a 65,000 square-foot expansion – representing…

December 9, 2020

Fareva enhancer: CureVac to use CDMO for COVID vaccine fill/finish

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Messenger RNA (mRNA) vaccine developer CureVac has contracted CDMO Fareva for the fill and finish of COVID-19 vaccine candidate. Under terms of the deal – financials of which have not been disclosed – contract development and manufacturing organization (CDMO) Fareva will provide fill and finish capabilities for CureVac’s COVID-19 vaccine candidate, CVnCoV, from facilities in Val-de-Reuil and Pau, both in France. “We are proud to contribute to the fill and finish manufacturing of this innovative vaccine candidate from CureVac,†said…

December 9, 2020

Politics and COVID driving manufacturing back to the US, says Avid

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“Southern California is not a bad place to be right now,†says CDMO Avid Bioservices as it discusses how politics and COVID-19 have made localized manufacturing more appealing. Contract development and manufacturing organization (CDMO) Avid Bioservices’s Myford and Franklin facilities are in California. Meanwhile, a third plant is in the works at the Myford site. But speaking last week to discuss its FY2021 Q2 results, CEO Nick Green did not dismiss the idea of expanding its capabilities further afield. “We…

December 7, 2020

BioLife invests in viral vector and freeze media tech firms

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BioLife Solutions has made investments in iVexSol and PanTHERA CryoSolutions, increasing its scope in the cell and gene therapy space. Life science tools firm BioLife Solutions and its partner Casdin Capital have invested a total of $4 million in iVexSol, as part of a $15.2 million Series A financing round, and $2 million in PanTHERA CryoSolution. iVexSol is a Massachusetts firm focused on developing its lentiviral vector (LVV) manufacturing technology platform. The startup claims the platform can produce LVVs at…

December 4, 2020

Atbtherapeutics secures plant-based production of targeted antibodies

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Atbtherapeutics has struck a deal with CDMO iBio for the manufacture and scale-up of its ‘atbody’ candidates using its plant-based expressions system. The deal, financials of which have not been divulged, will see contract development and manufacturing organization (CDMO) iBio work with atbtherapeutics to industrialize the GMP manufacturing process for atbtherapeutics’ atbodies. ‘atbodies’ are a novel class of biologics developed by Belgium-based biotech atbtherapeutics. They are composed of full-length antibodies, peptide linkers, and toxic peptide payloads, much like an antibody-drug…

December 4, 2020

Bayer launches CGT unit on back of Bluerock and AskBio acquisitions

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Having closed its $2 billion acquisition of Asklepios BioPharmaceutical (AskBio), Bayer has established a cell and gene therapy platform. The Cell and Gene Therapy (C&GT) Platform within Bayer’s Pharmaceuticals division aims to bring various acquisitions, capabilities, and assets together. According to the firm, the unit “will provide an innovation ecosystem within which the different participating partners, whether they be independent companies or strategic collaborators, can operate most effectively. They keep and further develop their passion and biotech spirit, scientific leadership…

December 4, 2020

Lonza building dedicated conjugation suites for ADC client

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The two dedicated suites in Visp, Switzerland will support commercialized antibody-drug candidates (ADCs) products for an undisclosed biopharma customer. Contract development and manufacturing organization (CDMO) Lonza has announced 1500 m2 of active manufacturing space will be dedicated to the biopharma customer, in addition to established quality control (QC) labs, logistics and other central services, to Charles Christy, head of Commercial Solutions Ibex Dedicate, Lonza, told us the customer has asked for confidentiality and so details are scarce, but the firm…

December 2, 2020

Germany’s Merck teams with Siemens to ‘digitalize’ production

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Merck KGaA will construct a €10 million ($12 million) modular plant at its site in Darmstadt, Germany as part of a collaboration with Siemens for the digitalization of production. The partnership aims to advance the development of a process control system for the manufacture of Merck’s products – including biopharmaceuticals and life science tools – by using Siemens’ tech platforms for the joint development of an overall system for automating the modular production. “We are able to setup any kind…

December 2, 2020