Author Archives: Dan Stanton

Jazz scales back Erwinaze push due to manufacturing disruptions

To minimize impact on patients, Jazz Pharmaceuticals has reduced promotion of its cancer drug due to continued manufacturing issues at its CMO Porton Biopharma Limited (PBL). Erwinaze (asparaginase Erwinia chrysanthemi), an asparaginase enzyme derived from the bacteria Erwinia chrysanthemi, is used for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase. The product is made for Jazz Pharmaceuticals by Wiltshire, UK-based and UK-government backed biomanufacturer PBL. However, the US Food and Drug…

YMC M&A: Lewa addition brings bioprocess tech and US market

Japanese separations resins firm YMC will buy the bioprocessing business of Lewa-Nikkiso America. The “friendly acquisition” includes a facility in Devens, Massachusetts. Privately-held Kyoto, Tokyo-based YMC will add a number of bioprocessing technologies through the acquisition, including staff and assets dedicated to the development, manufacture and sales of batch and continuous chromatography equipment, and buffer dilution systems for the biopharmaceutical market. Financial details have not been divulged. Gerard Gach, chief marketing officer at Lewa- Nikkiso America, told BioProcess Insider Lewa’s…

Samsung Bioepis: From biosimilars to novel biologics

Following success with several biosimilars, bringing a novel biologic into the clinic is the “next logical step” in becoming a fully integrated biopharma firm, says Samsung Bioepis. Almost a year to the date it announced a co-development agreement, Samsung Bioepis and Takeda Pharmaceuticals are preparing to begin a Phase I trial for its lead candidate, SB26, also known as TAK-671. The news signals the latest stage in the development of Samsung Bioepis – a joint venture between South Korean contract…

Alnylam’s success brings first RNAi therapeutic to US

The US Food and Drug Administration (FDA) has approved the first ever RNA interference (RNAi) therapy: Alnylam’s Onpattro (patisiran). Alnylam announced last week Onpattro has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. The product was hailed by the FDA as the first in a new class of drugs: small interfering ribonucleic acid (siRNA) treatments. “New technologies like RNA inhibitors, that alter the genetic drivers of a disease, have the…

MilliporeSigma partners Innocore for sustained release tech

MilliporeSigma will offer customers access to a sustained release formulation platform for large molecule APIs through a partnership with Innocore. The bioprocessing equipment and tools subsidiary of Germany’s Merck KGaA, MilliporeSigma, has inked an agreement to be the partner for the introduction of Innocure’s SynBiosys biodegradable platform to the global biopharma market. The platform can be used to develop sustained release solutions for biologicals in injectable formulations, something MilliporeSigma said is becoming increasingly important and competitively tempting for biopharmaceutical developers.…

Celltrion receives FDA 483 with 8 ‘manageable and correctible’ observations

Celltrion has received a US FDA Form 483 at its troubled biomanufacturing plant in Korea with eight observations not raised in a previous warning letter. In January, the US Food and Drug Administration (FDA) sent Korean drugmaker Celltrion a warning letter​ highlighting “multiple poor aseptic practices” at its production site in Songdo, Incheon. An FDA reinspection last month has now resulted in a Form 483 with eight observations. The 483 itself, uploaded by the Agency, cites issues with Celltrion’s drug product and…

Anti-antibody anybody? Bio-Rad range to target Lucentis biosimilar developers

Bio-Rad has launched a range of anti-ranibizumab antibodies for PK and immunogenicity assays on the back of increased Lucentis biosimilar development. Bio-Rad Laboratories will offer customers a range of recombinant monoclonal anti-ranibizumab antibodies that are highly specific for Lucentis (ranibizumab), or the complex of ranibizumab with its target, vascular endothelial growth factor A (VEGF-A). The anti-antibodies are to be used in pharmacokinetic (PK) and immunogenicity assays, and the product launch is due to the increased interest in Lucentis biosimilar development,…

Repligen riding high on Protein A strategic partnerships

Repligen says strategic partnerships are strengthening its proteins business, following a quarter which saw deals inked with Navigo Proteins and Purolite. For the second quarter 2018, bioprocessing tools and equipment supplier Repligen Corporation reported total revenues of US$48 million (€42 million), up 47% on the same period last year. The firm also reported sequential gains in its proteins franchise, where revenue increased nearly 10% over the first quarter. The segment includes its Protein A chromatography ligand and cell culture capture…

Regeneron teams up and takes $100m stake in bluebird bio

Regeneron has increased its interest in cellular therapies through a T cell co-development partnership with bluebird bio. The deal sees Regeneron Pharmaceuticals and bluebird bio combine their respective tech platforms to discover, develop and commercialize an initial six candidates against tumor-specific proteins and peptides, including chimeric antigen receptor (CAR) T and other T cell receptors (TCRs). As part of the collaboration, Regeneron has invested $100 million (€87 million) in its new partner bluebird, buying 420,000 shares at a price of…

Esco Aster to transfer CAR-T tech to Chinese biomanufacturing plant

The Singapore-based CDMO will fit out Wuhan Bio-Raid Biotechnology’s facility in China with its lentiviral vector platform and bioproduction technologies. Esco Aster has signed a memorandum of understanding (MoU) to use its lentiviral vector platform and bioproduction technologies to support Wuhan Bio-Raid’s chimeric antigen receptor (CAR) T-cell therapy pipeline in China. “Under the MoU, both parties have achieved a broad understanding to increase the speed of CAR-T development in China,” Esco Aster spokesperson Ai San Yip told BioProcess Insider. This…