Facilities & Capacity Archives - Page 67 of 73 - BioProcess InternationalBioProcess International

Prefab sprouts in China as BeiGene selects GE for MAb facility

Much of Asia lacks traditional biomanufacturing infrastructure according to GE Healthcare, which says prefabricated facilities like its KUBio platform can support the rapid biologics growth in the region. BeiGene Ltd inked a deal with GE Healthcare in 2015 to install the bioprocessing vendor’s FlexFactory platform at its clinical monoclonal antibody facility in Suzhou, China. Three years on and the Chinese biotech firm has chosen GE Healthcare’s prefabricated biomanufacturing facility offering KUBio for commercial production of cancer MAbs at a site…

BIA Separations opens upstream lab; looks to future expansions

by BPI Staff

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…

Catalent clears up FDA 483 concerns at Indiana plant

by Dan Stanton

The plant in Bloomington received a Form 483 with five observations in May, but Catalent says a second US FDA inspection shows issues have been resolved. The US Food and Drug Administration (FDA) recently published a Form 483 it issued to Catalent’s biomanufacturing facility in Bloomington, Indiana following an inspection in April and May this year. The Agency made five observations at the 875,000ft2 production and fill/finish facility, which the contract development and manufacturing organization (CDMO) gained as part of…

Biocad teams with SPH to build Chinese biomanufacturing plant

by Dan Stanton

Russian drugmaker Biocad and Shanghai Pharmaceuticals Holding (SPH) have formed two joint ventures to develop and make originator and biosimilar antibodies in China. At the Eastern Economic Forum (EEF), a memorandum of understanding has been signed between the two companies, establishing two joint ventures aimed at developing and manufacturing several monoclonal antibodies intended for the Chinese market. “The project itself is focused on four molecules and two original products,” Biocad spokesperson Irina Kenyukhova told BioProcess Insider. “Due to the fact…

Exclusive: Samsung BioLogics poised to enter cell therapy space

by Dan Stanton

After building three large-scale biomanufacturing plants, CDMO Samsung BioLogics has told BioProcess Insider it is adding single-use capacity and is considering expanding into stem cell therapy services. It has been nine years since Samsung BioLogics entered the third-party biologics space, in which time it has brought two commercial biomanufacturing facilities online with a third expected to be fully validated by the end of this year. When operational, the firm’s site in Incheon, South Korea will boast a total of 362,000…

Shire buys sanaplasma AG to support immunology business

by BPI Staff

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…

BioMarin building $50m Irish fill/finish plant for orphan enzymes

by Dan Stanton

The drug product plant in County Cork will support the fill and finish of BioMarin’s rare disease drugs Vimizim (elsulfase alfa) and Brineura (cerliponase alfa). The filling facility at BioMarin’s site in Shanbally, County Cork represents an investment of €43 million ($50 million) and will create 51 additional jobs. “We regularly evaluate our manufacturing capabilities and which capabilities we do ourselves and which make sense to outsource,” BioMarin spokesperson Debra Charlesworth told BioProcess Insider. “Based on our current business needs…

With third bio-train complete, Catalent eyes fourth and fifth in Wisconsin

by Dan Stanton

CDMO Catalent is considering adding two more manufacturing trains at its Madison facility due to anticipated demand for sub-5,000 L biomanufacturing. For Catalent’s fourth quarter FY2018, sales from its Biologics and Specialty Drug Delivery business stood at US$196 million (€168 million), twice that of the same period last year. The contract development and manufacturing organization (CDMO) attributed much of this increase to the acquisition of Cook Pharmica and the addition of a biomanufacturing facility in Bloomington, Indiana. However, management told…

Sartorius opening life sciences launchpad to grow German talent and innovation

by BPI Staff

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.…

Gilead says CA plant will supply Yescarta to EU until 2020

by Dan Stanton

Kite’s manufacturing plant in El Segundo, California, will supply Europe with the newly approved CAR-T therapy Yescarta while a facility in The Netherlands is being prepared. Gilead Sciences has received marketing authorization from the European Commission (EC) for its chimeric antigen receptor T (CAR-T) cell therapy Yescarta (axicabtagene ciloleucel). The therapy is approved to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL). “Across the European Union, it is estimated that…