Author Archives: BPI Staff

GMP round-up: Samsung Bio becomes bigger, Rentschler fills aseptic gap

Korean CDMO Samsung BioLogics says its third facility is GMP ready and the largest single biomanufacturing plant in the world. Meanwhile, Rentschler has received GMP certification for an Austrian fill/finish plant. Samsung BioLogics has begun production at its third plant at its site in Incheon, South Korea. With 180,000 L of capacity from 12 times 15,000 L tank, the plant is the world’s largest single facility, according to the contract development and manufacturing organization (CDMO). It took Samsung BioLogics 10…

Double deal with Asterias gives Novo Nordisk CA stem cell plant

Novo Nordisk will pay Asterias $2 million to lease a facility in Fremont, California for the supply of stem cell-based therapies. An manufacturing tech licensing deal is also an option. Danish drugmaker Novo Nordisk intends to set up manufacturing capabilities for its clinical phase stem cell therapies for type 1 diabetes and other chronic diseases from 2019 onwards after subleasing the plant in California from Asterias Biotherapeutics. The 44,000 square feet current good manufacturing practices (cGMP) facility is used as…

Alexion refilling pipeline through potential $1.2bn Syntimmune buy

The acquisition of early-phase biotech Syntimmune is “part and parcel” to Alexion Pharmaceuticals’ plan to build up its pipeline, says the firm’s CFO. Alexion Pharmaceuticals has entered into an agreement to buy Syntimmune for an upfront payment of $400 million (€342 million), though milestone payments could see the firm shell out a further $800 million. The deal brings Alexion SYNT001, a humanized monoclonal antibody candidate that inhibits the interaction of FcRn with Immunoglobulin G (IgG) and IgG immune complexes. The…

AGC adds mammalian capabilities to Japanese network

Demand for mammalian biomanufacturing services has led AGC Bio to invest in its facility in Chiba, Japan. Contract development and manufacturing organization (CDMO) AGC Bio is adding a new facility at its site in Chiba containing single-use bioreactors at the 500 and 2,000 L scale. The plant, expected to be operational by the second half of next year, will produce monoclonal antibodies (MAbs), fusion proteins and other types of therapeutic proteins for its customers. “The facility is being established for…

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…