Author Archives: BPI Staff

BIA Separations opens upstream lab; looks to future expansions

The newly opened lab looks to optimize the interface between upstream and downstream processing, says Slovenian bioprocessing firm BIA Separations. Developed on the back of customer demand, the upstream processing laboratory aims to optimize the critical interface between upstream and downstream processing for the production of complex molecules and biologics. BIA Separation CEO Aleš Štrancar said that product-contaminant complexes formed during upstream production represent a consistent and challenging obstacle for downstream processing. “These complexes interfere with every aspect of bioprocessing…

Shire buys sanaplasma AG to support immunology business

Shire adds 14 centers to its European-based plasma collection network through an acquisition aimed at extending long-term plasma supply. Plasma is essential to the manufacture of immunoglobulin therapies for certain rare immunological diseases. Shire, which prides itself on orphan and hemophilia drugs, has more than 100 plasma collection centers in the US and Austria and has further expanded its presence through the acquisition of sanaplasma AG. “The transaction was an acquisition of 100% of sanaplasma AG,” Shire spokesperson Paris Barker…

KBI boosts analytical services with Belgium expansion

The laboratories in Belgium will help international biopharma firms consolidate their outsourced analytical work to meet EU regulations, says KBI Biopharma. Contract development and manufacturing organization (CDMO) KBI Biopharma has opened laboratories in Leven, Belgium offering analytical development, formulation development, biopharmaceutical characterization and cGMP quality control testing. According to CEO Tim Kelly, the lab expansion was first announced in 2015, when the CDMO was acquired by JSR Corporation. “JSR’s decision to expand its A3 production capacity in Leuven created an…

Sartorius opening life sciences launchpad to grow German talent and innovation

Bioprocessing vendor Sartorius has launched a Life Science Factory in Göttingen, Germany offering labs, co-working spaces and consulting services for life science entrepreneurs. Life Science Factory, an independent non-profit division of Sartorius, aims to set-up a launch pad for life science startups in Germany. According to spokesperson Timo Lindemann, the project will begin next year with more than 500m2 for co-working, experiments and events, available for rent by entrepreneurs, before being transferred to a new 3,000m2 nearby facility in 2021.…

BioProcess Insider BPI Theater @ BIO 2018 Interviews – Tuesday

BioProcess Insider brings the news as it breaks. 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 we summarize his DAY ONE conversations with a number of biopharmaceutical executives on Tuesday 5 June 2018. You can watch the full interviews online at www.bioprocessintl.com/BIO-Theater-2018. Andy Topping, Chief Scientific Officer, Fujifilm Diosynth Biotechnologies Gene therapies show…

Kyowa Hakko fermentation plant hit with FDA warning

Kyowa Hakko has received a US FDA warning letter citing GMP and data integrity issues at its amino acid production facility in Yamaguchi, Japan. The warning letter dated August 10 2018 came following an inspection of Kyowa Hakko Bio’s Hofu facility in September 2017 by the US Food and Drug Administration (FDA). Deviations from current good manufacturing practice (cGMP) for active pharmaceutical ingredients (API) cited by the Agency included failures in Kyowa Hakko’s quality unit, along with a lack of…

Therapeutic Modalities: Business and Manufacturing Strategies Influencing Decisions to Develop One Therapy Type Rather Than Another

Moderator Patricia Seymour, with John Lee, Michael Kaufman, Jennifer Michaelson, and Weichang Zhou Following introductions of the panelists and their companies’ technologies, moderator Patricia Seymour began the discussion about challenges related to choosing different modalities and addressing related manufacturing concerns. Targeting Modalities Michaelson began by describing how Cullinan Oncology selects its targets and modalities, how it approaches those early phase decisions, and what its primary driver is to get into the clinic as quickly as possible. She talked about challenges…

Feeding the Demand for Cell and Gene Therapy Production

Moderator Dan Stanton, with Ohad Karnieli, Alan Moore, and David Brindley Moderator Dan Stanton introduced the second roundtable of Tuesday morning by commenting on the recent spate of approvals for CAR-T cell and gene therapies. With large biopharmaceutical and biotechnology companies devoting scientists and funds toward these next-generation therapies, contract manufacturing organizations (CMOs) also are investing in opportunities to expand capacity and expertise. As the panelists introduced themselves, they raised two key points for discussion: The contracting model for advanced…

BioProcess Insider BPI Theater @ BIO 2018 – Wednesday Interviews

BioProcess Insider brings the news as it breaks. 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 we summarize and share the videos from his DAY TWO conversations with a number of biopharmaceutical executives on Wednesday 6 June 2018. Sean Sommer, Vice President of Advanced Facilities, Jacobs Jacobs offers a range of services…

Using New Technologies to Compress Timelines, Increase Capacity, and Reduce Costs: Speed — Why, When, and How

Moderator Tom Ransohoff, with Jorg Thommes, Chris Love, Rajesh Beri, and Geoffrey Hodge For biopharmaceuticals to mature as a process industry, companies need to embrace the ability to adopt new technologies and bring new operational approaches to their biomanufacturing facilities. In this roundtable about adopting and implementing new technologies in the biologics industry, moderator Tom Ransohoff stressed the importance of understanding drivers for adopting new technologies and of developing enabling processes that factor in associated risks and challenges. He offered…