Therapeutic Class

COGS crisis: Cell therapy sector must rethink CMC says expert

The cell therapy sector faces a cost of goods sold (COGS) crisis and needs to get beyond the “product is the process” mind-set says Anthony Davies, CEO of Dark Horse Consulting. Cell and gene therapies have attracted a lot of attention in recent years. In part this is because drugs like Yescarta, Kymriah and Zolgensma have been approved as one-off cures. However, their cost – $373,000, $475,000 and $2.1m per vial in the US, respectively – has also seen them…

A booster shot for vaccines: Univercells working to cut production costs

Vaccines cost too much to make according to Univercells, which aims to have a novel platform ready for commercial-scale production by 2020. Vaccines have had a dramatic impact on human health. One recent study argued that vaccine development “represents humankind’s most important and successful endeavor… over the last 200 years” [1]. Many diseases that caused millions of deaths in generations past have been stopped in their tracks by industry-supported vaccination programmes run by entities like World Health Organization (WHO), UNICEF and…

GE: Learning from MAb automation to tackle CAR-T

GE Healthcare says monoclonal antibodies laid the groundwork for its workflow technologies, allowing accelerated uptake of automation in the autologous cell and gene therapy space. In May, bioprocessing tools and services firm GE Healthcare launched its Chronicle automation software for cell therapy manufacturing. The offering supports the complete workflow for cell therapy products including the optimization of manufacturing from process development to commercialization. Talking to Bioprocess Insider at the BPI Theater at BIO in June, Catarina Flyborg, GM of GE’s…

Garbage in, garbage out: Raw material quality crucial for cell & gene therapies

Cell and gene therapy makers have suffered manufacturing setbacks, but experts working in the supply chain say ensuring high quality raw material is the key to success. Manufacturing issues have plagued the few advanced therapies to have made it to the market. Dendreon’s Provenge (sipuleucel-T) suffered from high complexity of manufacturing and administration, Novartis’ Kymriah (tisagenlecleucel) saw some variability in its product specifications, and – most recently – Bluebird Bio has been accused of lacking manufacturing readiness for its recently…

Merck builds up Gardasil network again with $680m NC injection

Merck & Co. will build a 225,000 square-foot facility in Durham to support production of its HPV vaccine Gardasil, creating 400 jobs. Merck will report its second quarter 2019 results on July 30, but for the previous quarter the firm saw a 31% year-on-year increase in sales of its human papillomavirus (HPV) vaccines Gardasil and Gardasil 9, which pulled in sales of $838 million (€752 million). Adam Schechter, Merck’s president of Global Human Health, said last year that his firm…

Lonza building out capacity to prep for ADC boom

CDMO Lonza already supports three of the five commercially available antibody-drug conjugates (ADCs) and is adding two news suites in Switzerland in preparation of future demand. Contract development and manufacturing organization (CDMO) Lonza will expand its bioconjugation facility in Visp, Switzerland in readiness for a new wave of antibody-drug conjugates (ADCs) coming through the clinic. “Many bioconjugates are on expedited programs and the existing expertise at the facility, combined with proximity to clinical and commercial manufacturing of antibody, linkers and…

BIA Separations providing chromatography columns for AveXis

BIA Separations’ prepacked chromatography columns “contribute to a robust manufacturing process” for the recently approved gene therapy Zolgensma, says AveXis. In May, the US Food and Drug Administration (FDA) approved Zolgensma (onasemnogene abeparvovec), a gene therapy designed to halt progressive spinal muscular atrophy (SMA). Novartis subsidiary AveXis developed and commercialized the $2.1 million one-off treatment, but – as the saying goes – it takes a village to raise a child. Zolgensma relies on Regenxbio’s adeno-associated virus (AAV) vector technology, and…

Avalon GE partnership looks to automate and accelerate CAR-Ts

Avalon GloboCare has teamed with GE Healthcare to establish automated and standardized cell production capabilities to support its cellular immunotherapy programs. Under terms of the deal, clinical stage biotech Avalon will access bioprocess vendor GE Healthcare’s FlexFactory Cell Therapy platform to develop a production infrastructure for its pipeline of Chimeric Antigen Receptor (CAR) T cells and other immune-effector cells for cellular immunotherapy. Avalon will also gain access to GE’s FastTrak process development and training services, as well as its extensive…

AveXis: ‘Speedy scale-up driven by Novartis acquisition’

With its own facilities, support from Novartis and now dedicated space at Catalent’s Paragon, AveXis says it has the most gene therapy manufacturing capacity in the industry. AveXis has inked a deal with contract development and manufacturing organization (CDMO) Paragon Gene Therapy to secure dedicated manufacturing space for its one-off spinal muscular atrophy (SMA) treatment Zolgensma (onasemnogene abeparvovec), approved in the US in May. Paragon’s facility in Maryland will also provide process development for clinical supply of other gene therapy…

CDMOs driving drug conjugate innovation, says ADC Bio

ADC Bio has completed construction of a cleanroom in Wales, part of an $11 million bioconjugation facility set to serve the robust demand for antibody-drug conjugate (ADC) services. The completion of the clean room forms part of the original secured investment for the construction of an $11 million (€9.8 million) bioconjugation facility at ADC Bio’s new site in Deeside, North Wales, UK. “Production is scheduled to commence once the entire bioconjugation facility has received it GMP accreditation from the MHRA,…