Author Archives: BPI Staff

BioProcess Insider Interviews at the BPI Theater @ BIO 2018 – Mass Bio and Bioasis

At the BPI Theater @ BIO, editor Dan Stanton conducted a series of interviews live on stage to report on the latest movements in the biomanufacturing industry to start each busy day of dealmaking in Boston. Below are the videos from conversations with David Lucchino, chairman, Mass Bio; and Mark Day, president and chief executive officer, Bioasis. Massachusetts: Secrets to Success Lucchino explains that when you have a set of companies in an area, it lays the groundwork for growth…

Astellas paying $110m for UK-based gene therapy firm

The acquisition of Quethera accelerates Astellas Pharma’s entry into the ophthalmic gene therapy space, the firm says. Japanese drugmaker Astellas has bought Cambridge, UK-based preclinical biotech for as much as £85 million (US$110 million) and will take over development of its lead candidate, a proposed gene therapy for the treatment of refractory glaucoma through an intraocular pressure (IOP)-independent mechanism. “This acquisition demonstrates Astellas’ commitment to proactively incorporate state-of-the-art scientific and technological advances and turn them into value for patients,” a…

Emergent: $270m PaxVax acquisition and Baltimore expansion boost CDMO biz

Emergent adds its first European biomanufacturing facility through the acquisition of vaccine maker PaxVax. Meanwhile in Baltimore, the firm has announced a $50 million fill/finish expansion. The US$270 million (€236 million) adds two vaccines approved by the US against cholera and typhoid fever to Emergent BioSolutions’ portfolio, along with several candidates including an Adenovirus 4/7 vaccine being developed for military personnel under contract with the US Department of Defense (DoD). The acquisition also brings Emergent its first biomanufacturing facility outside…

Ceramic Hydroxyapatite Chromatography Media – How to Start

This webcast features: Dr. Mark A. Snyder, Manager of the Process R&D Applications Group in the Process Chromatography Division of Bio-Rad Laboratories Our newest mixed-mode media, Ceramic Hydroxyapatite XT, is a calcium affinity cation exchange chromatography media. It is used for the purification of numerous types of biomolecules and provides single-step clearance of impurities and aggregates for monoclonal antibody purification. CHT XT is an easy-to-use mixed-mode chromatography media. Unlike other chromatography media it is both the ligand and the support…

Plant Round-Up: Rubius Buys, WuXi Begins, Samsung Approved

Alexion sells its troubled plant to Rubius; Samsung BioLogics receives its first US license to make a Mab drug product; WuXi Biologics completes a GMP run at its Shanghai facility. Welcome to Insider’s facility round-up. Earlier this month, BioProcess Insider reported newly public Rubius Therapeutics had pledged to invest US$155 million (€133 million) to purchase, renovate and customize a facility in Smithfield, Rhode Island. At the time, the firm refused to divulge who they bought the facility from, but in…

Newly Public Rubius Investing $155m to Renovate Rhode Island Plant

Rubius Therapeutics will use some of the US$241 million (€207 million) raised in its initial public offering (IPO) to buy and refurbish a manufacturing facility. The biotech firm begins trading on Nasdaq Global Select Market today (July 18) after raising $241 million from the public offering of 10,483,000 shares of common stock. According to the firm’s Form S-1, filed with the SEC, some of the proceeds will be used to “purchase, renovate and customize the manufacturing facility for which we…

Validation of the MycoSeq Mycoplasma Detection Kit for the Release of Veterinary Products

This webcast features: Sébastien Lievyns, Scientist, and Dr. Anne Thomas, Senior Principal Scientist, Analytical Sciences, Zoetis This webcast aims to show how Zoetis has validated the MycoSeq kit for the release of animal products. The Analytical Sciences group at Zoetis confirmed the limit of detection at 10 CFU/mL and good repeatability and intermediate precision of the qualitative mycoplasma qrt-PCR method in presence of these products. For direct PCR performed on vaccine, a background amplification is sometimes observed inducing a signal…

Entegris: ‘Flex Acquisition Helps Supply Chain Security’

Entegris has acquired Flex Concepts, adding upstream tech to its bioprocessing equipment offering. The deal – financial details of which have not been divulged – will see Entegris add bioprocessing single-use bags and fluid transfer solutions to its life sciences offering. “Flex Concepts manufactures quick turn custom configured products primarily for the biopharmaceutical industry. They sell products to some of the top pharma and biopharma companies,” Eric Isberg, director of Life Sciences for Entegris, told BioProcess Insider. “Flex had primarily…

Biogen Upping Stake in Biosimilars JV

Biogen has agreed to pay around US$700 million (€602 million) to increase its stake in biosimilars joint venture Samsung Bioepis from 5.4% to 49.9%. Samsung Bioepis was formed in 2012 as a joint venture between Samsung BioLogics and Biogen to develop biosimilar drugs. Under terms of the deal, Biogen had the option to increase its single-digit involvement to 49.9% by mid-2018, something the firm announced it would be doing Thursday. “We are very pleased with the progress made to date…

US FDA Calls Biologic Makers to ‘INTERACT’ With New Program

The Agency has launched the INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) program to help sponsors plan development projects more effectively. The program is being introduced by the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) to allow potential sponsors to engage with Agency staff and obtain advice on a specific topics or issues critical to early product development. The discussions aim to advance product development by answering sponsors’ questions, removing roadblocks,…