Upstream & Downstream Processing

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…

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…

Q2 Results: Bioprocessing Vendors Return to Double-Digit Growth

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…

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…