Upstream & Downstream Processing

Lonza: CAR-T Manufacturing Glitch an Industry Problem, not Just Novartis’s

Novartis has reported issues around the manufacture of Kymriah (tisagenlecleucel). With CAR-T being a new field, teething problems are normal, says CDMO Lonza. In August 2017, Novartis became the first company to receive US Food and Drug Administration (FDA) approval for a chimeric antigen receptor (CAR) T-cell therapy. But during its Q2 results, the Swiss Biopharma admitted some issues in the manufacturing of the therapy for its diffuse large B-cell lymphoma (DLBCL) indication. “We have seen some variability in our…

Danaher Praises Pall for Returning Biopharma to ‘High Growth Norm’

Strong demand for single-use technologies has returned double-digit growth for Pall, contributing to a “return to normality” for Danaher Corporation’s life sciences business. For its second quarter 2018, Danaher Corporation reported total revenues across its life sciences businesses of US$1.6 billion (€1.4 billion), up 16% over the same period last year. The multinational attributed much of the growth to Pall Corporation – the filtration, separations and purification firm it acquired for $13.6 billion in 2015 – though CEO Tom Joyce…

Pluristem and Thermo Fisher Look to Plug Gaps in Cell Therapy Manufacture

Pluristem and Thermo Fisher will work to address the lack of technologies available to cell therapy manufacturers for the cultivation and processing of allogeneic products. “There is a lack of technologies for the cultivation and processing of allogeneic products whose potential is high scale production,” Yaky Yanay, president and co-CEO of Pluristem Therapeutics told BioProcess Insider. “Some of the gaps are in the technology itself, some are in the quality or the availability of raw materials.” To minimize some of…

Shanghai Filling Line is Latest Investment in China for B-I

Boehringer-Ingelheim will offer both drug substance and drug product services form its facility in Shanghai, China after adding fill & finish capabilities. German drugmaker Boehringer Ingelheim has added a new filling line at its commercial biomanufacturing facility in Shanghai, bolstering its third-party business, BioXcellence. “At our China facility the F&F [fill & finish] service complements the manufacturing service for drug substance at that site, meaning we can now offer drug substance and drug product out of one facility for our…

Therapy First, Efficiency Second: Why We Should Stop Focusing on Manufacturing Costs

Drug substance manufacturing only contributes around 5% on average to the total cost of a biologic says GE Healthcare’s Guenter Jagschies. Payors, patients and governments are increasingly looking to industry to justify the high prices of prescription drugs. As new immuno-oncology treatments are being launched with increasingly higher price tags and often the cost of producing these complex biotherapeutics. “This industry is not pricing based on cost, it is pricing based on perceived value,” Guenter Jagschies, senior director of strategic…

Compact Manufacturing: Next-Gen Media Could Save $30k per Run, Amgen

Granulation and concentrates will improve media compounding speed and manufacturability of Amgen’s next-generation biologics, the firm says. In 2014, Amgen opened a US$200 million (€168 million) next-generation production facility in Singapore intended to manufacture biologics with greater speed, productivity and flexibility. The model is being replicated at another facility under construction at Amgen’s West Greenwich, Rhode Island, campus. The two manufacturing plants are based on enabling technologies including single-use, modular design, and process intensification. Smaller Manufacturing but Larger Media Footprint…

GE Considers Broadening ‘Brilliant’ Approach to Media Manufacturing

GE Healthcare has implemented its Brilliant Manufacturing software at a plant in Utah, and says it is looking to broaden the analytics platform across its cell culture media network. In 2015, bioprocessing tools and equipment firm GE Healthcare launched its Brilliant Manufacturing Suite aimed at increasing production efficiency and optimization through analytical software. While offered as a service to its customers, the firm has also implemented the technology at its own facilities, including as part of a manufacturing transformation project…

Hyperstack Shortage Caused by Gene Therapy Surge

The adoption of viral vector technology in cell and gene therapy has led to six month waiting lists for multilayer culture vessels. Hyperstack vendor Corning says it will more than double its manufacturing capacity to deal with the demand. Despite being a registered brand owned by Corning Life Sciences, ‘hyperstack’ has become a common term to describe multilayer, scalable, and single-use culture flasks. They are used to produce viral vectors and gene therapies, and are in huge demand, according to…

Entegris: ‘Flex Acquisition Helps Supply Chain Security’

Entegris has acquired Flex Concepts, adding upstream tech to its bioprocessing equipment offering. The deal – financial details of which have not been divulged – will see Entegris add bioprocessing single-use bags and fluid transfer solutions to its life sciences offering. “Flex Concepts manufactures quick turn custom configured products primarily for the biopharmaceutical industry. They sell products to some of the top pharma and biopharma companies,” Eric Isberg, director of Life Sciences for Entegris, told BioProcess Insider. “Flex had primarily…

Industry Looks to ‘Lucrative’ Opportunities for Off-the-Shelf Cell Therapies

Allogeneic cell therapies have greater commercial potential than autologous products, an industry survey finds. Respondents also believe there are a lack of third-party capabilities to make these new therapies. When Novartis’s Kymriah (tisagenlecleucel) received the regulatory thumbs up in August 2017, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb described regenerative medicines as being “no longer the stuff of science fiction.” The approval of Gilead/Kite’s Yescarta (axicabtagene ciloleucel) weeks later helped cement the safety and commercial potential of CAR-T…