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US made biosimilars: Competitive advantage or marketing spin?

Coherus says American healthcare providers and payers favor biosimilars made in the US over those made overseas. But an industry analyst has dismissed this saying location should not matter provided the facility is approved. Coherus’ second quarter 2018 contained several regulatory milestones relating to its candidate Udencya (pegfilgrastim-cbqv), a biosimilar candidate to Amgen’s Neulasta. A resubmission to the US Food and Drug Administration (FDA) was accepted in May, while in July Europe’s Committee for Medicinal Products for Human Use (CMPH)…

Bavarian Nordic: €30m loan to support smallpox vaccine fill/finish plant

by Dan Stanton

The loan will support construction of a facility aimed at bringing the full production of Imvamune in-house. The news comes a year after Bavarian Nordic won a US$539 (€472) million contract to supply the freeze-dried smallpox vaccine to the US government. Danish biotech Bavarian Nordic secured the loan from the European Investment Bank. During its second quarter results, CEO Paul Chaplin said the loan both secures the firm’s cash position and supports investments in its manufacturing network. This includes production…

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

by Dan Stanton

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…

MilliporeSigma partners Innocore for sustained release tech

by Dan Stanton

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.…

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

by Dan Stanton

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…

Amgen Breaks Ground on $160m Rhode Island Plant

by Dan Stanton

Amgen has broken ground on a single-use and modular biomanufacturing facility at a site in Rhode Island. The groundbreaking ceremony at the West Greenwich site took place today in the presence of the governor of Rhode Island, Gina Raimondo and congressman Jim Langevin. Construction of the plant will begin in September. The facility, first announced in April, will make biologics for the US and global market once operational. It has been described as a “next-generation biomanufacturing plant,” meaning it is…

Q2 Results: Bioprocessing Vendors Return to Double-Digit Growth

by Dan Stanton

Thermo Fisher and Sartorius are among bioprocessing vendors reporting a return to double-digit year-on-year growth, following ‘lumpy’ results in the same quarter 2017. For the second quarter 2018, Thermo Fisher reported revenues from its Life Sciences Solution segment of US$1.6 billion (€1.4 billion), up 12% on the same period last year. Fellow vendor Sartorius reported Q2 sales in its Bioprocessing Solutions unit up 14% in constant currency over last year, pulling in €287 million ($336 million), while order uptake was…

Bioproduction: A ‘Tale of Two Facilities,’ Says Jacobs

by Dan Stanton

The advent of single-use bioreactors has revolutionized facility design says Jacobs, which has worked in the biomanufacturing sector for almost 30 years. As the biotech industry matured in the 1990s, Jacobs Engineering acquired Triad Technologies and Sigel Group to expand its expertise in designing and constructing biotechnology facilities. The firm has since been involved in many of the most prominent biomanufacturing facilities over the past few decades, working on Schering-Plough’s (now Merck & Co.) facility in Tuas, Singapore; Bristol-Myers Squibb’s…

Neupogen Biosimilar Success: Pfizer Banks on Discounts and Patient Confidence

by Dan Stanton

The US Food and Drug Administration (FDA) has approved Pfizer’s Nivestym; a second biosimilar of Amgen’s Neupogen (filgrastim). In March 2015, the FDA approved its first biosimilar: a version of Neupogen called Zarxio, marketed by Novartis subsidiary Sandoz. Three years later and a second filgrastim biosimilar is close to being available after the FDA approved Pfizer’s product NIvestym. A spokesperson from the Biopharma firm told BioProcess Insider Pfizer will be able to compete against both Amgen’s reference biologic and Sandoz’s…

Univercells $19m Booster Shot to Help Disrupt Vaccine Industry

by Dan Stanton

Traditional vaccine makers have limited incentive to invest in new technologies and processes says Univercells, which hopes to advance its own viral vaccines produced in micro-facilities. Univercells has raised €16 million (US$18.7 million) of funding in a Series B financing round led by Global Health Investment Fund. Some of the capital will be used to increase the impact of its proprietary viral platform through the expansion of its portfolio. “Following the platform proof of concept, with its sIPV development program…