Author Archives: Dan Stanton

Oxford Genetics: CRISPR patent war casts shadow over use in cell line development

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CRISPR engineered mammalian cell lines are more cost effective than other gene editing platforms says Oxford Genetics, but adopting such tech is perceived a risk due to ongoing patent issues. Oxford, UK-based synthetic biology firm Oxford Genetics has inked a multi-billion-dollar deal with an undisclosed ecommerce provider of reagents and tools for its high throughput automated genomic engineering platform for CRISPR modification of mammalian cell lines. While details are undisclosed, the deal shows how the firm has harnessed the gene-editing…

August 20, 2018

Ex-Shire director to aid Catalent’s shift to commercial manufacturing

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The new general manager at Catalent’s facility in Wisconsin says his experience at Baxter and Shire will help the plant transition towards commercial manufacturing. Contract development and manufacturing organization (CDMO) Catalent has appointed Graham Brearley as general manager of its Madison, Wisconsin facility. With over 25 years’ of technical, operations and business experience in the biopharmaceutical industry, BioProcess Insider spoke to him about his move to a third-party services firm and his vision for Madison – and Catalent – going…

August 16, 2018

Jazz scales back Erwinaze push due to manufacturing disruptions

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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…

August 16, 2018

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

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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…

August 14, 2018

Samsung Bioepis: From biosimilars to novel biologics

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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…

August 13, 2018

Alnylam’s success brings first RNAi therapeutic to US

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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…

August 13, 2018

MilliporeSigma partners Innocore for sustained release tech

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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.…

August 9, 2018

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

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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…

August 8, 2018

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

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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,…

August 7, 2018

Repligen riding high on Protein A strategic partnerships

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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…

August 7, 2018