Author Archives: BPI Staff

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…

PBL 3,000L Plant Could Alleviate Erwinaze Shortage

Porton Biopharma Limited (PBL) has opened a facility in Wiltshire, UK to make cancer drug Erwinaze (asparaginase Erwinia chrysanthemi). PBL is a biomanufacturer owned by the UK Government. Construction of the 2,100 m2 facility began in May 2016, through a multi-million pound investment from the UK’s Department of Health Capital funding. The plant has opened its doors and full production is set to commence over the next 12 months once the process of qualifying and validating the equipment is complete.…

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,…

WuXi Pumps $20m into Conjugation and Fill/Finish Site

WuXi Biologics has begun building a biologics conjugation and drug product plant in China to support antibody-drug conjugate (ADC) services. To be known as DP3, the 6,000m2 facility will be the third drug product site for the contract development and manufacturing organization (CDMO) and is expected to be open next year. The facility in Wuxi City, China will offer both clinical and commercial antibody-drug conjugate (ADC) services and will be an extension of similar conjugation and fill/finish operations at WuXi’s…

June Spotlight

Holding True to the Price-Cap Pledge As in previous years, 2018 started with more than 30 drugs increasing in price on the US market. However, data and analysis firm GlobalData observes that criticism from politicians and the public seems to be keeping the industry to a 10% self-imposed price-hike limit. It began with Allergan CEO Brent Saunders pledging to police pricing in 2016, when he stated that his company would limit itself to one price increase per year and only…

Jefferson Bioprocessing Institute Aims to Feed High Demand for Skilled Workers

GE Healthcare and Ireland’s NIBRT will support the Jefferson Institute for Bioprocessing, set to open its doors next year. The site in Pennsylvania will train around 2,500 people in biomanufacturing operations per year. “There is high demand for trained professionals in the growing fields of biologics,” Debbie Goldberg, director of Public Relations at Jefferson (Philadelphia University + Thomas Jefferson University), told BioProcess Insider. As such, the education and training institute for bioprocessing has selected a site and will open its…

BioSymphony No. 1: Oncobiologics Wins First CDMO Deal

Sonnet BioTherapeutics has contracted Oncobiologics to develop and manufacture four undisclosed biologic compounds. The Master Services Agreement (MSA) with Sonnet BioTherapeutics is the first to leverage Oncobiologics’ BioSymphony Platform, consisting of in-house monoclonal antibody (mAb) development and manufacturing capabilities. Lawrence Kenyon, Oncobiologics’ CFO, told BioProcess Insider the platform is used in a small biotech company setting, which results in a “more efficient and timely process for bringing mAbs forward.” He continued: “Our goal, and the purpose of the platform, is…