Author Archives: Dan Stanton

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…

VGXI to supply plasmid for Geneos’ cancer DNA vaccines

Plasmid manufacturer VGXI has entered a long-term supply agreement to support development of Geneos Therapeutics’ personalized cancer vaccines. “DNA vaccines are unique from typical vaccines in that they contain no protein components,” Christy Franco, senior manager of BD at VGXI, told this publication. “A synthetic, circular DNA encodes for portions of the patient’s tumor that have been identified as immunogenic. After delivery, the DNA vaccine expresses those protein segments which trigger your body’s immune system to identify, track down, and…

‘Bioprocessing ecosystem is on fire,’ says analyst

Sales grew 21% year-on-year at Sartorius’ H1 2019, while Repligen reported preliminary Q2 growth of nearly 50%. The bioprocessing sector ‘is on fire,’ says Jefferies’ analyst Brandon Couillard. Repligen Corporation published its preliminary Q2 results in an SEC filing last week, saying it expects sales of $70-71 million, compared to $47.7 million for the three months ended June 30, 2018. This would represent a 48% increase year-on-year. “The 8-K did not offer much color on specific drivers, but momentum across…

Pall to provide ‘A-Z of single-use tech’ in Servier deal

Servier has selected Pall Corporation as its exclusive technology and services provider at its biomanufacturing facility in Gidy, France. The facility, located about 50 km south of Paris, forms part of Servier’s oncology drug development and production network, Bio-S. This unit will be used for the manufacture of recombinant proteins and monoclonal antibodies, using equipment and processes supplied and supported by Pall Biotech. “Pall will assist Servier with technical support for the scale up of the process to enable Servier…

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…

Multiple myeloma MAb helps drive Q2 as J&J looks to subcu formulation

J&J has reported a 57% year-on-year growth for its multiple myeloma monoclonal antibody Darzalex (daratumumab) and is now hoping to increase adoption through a subcutaneous formulation. For its second quarter 2019, Johnson & Johnson clocked in sales of $10.5 billion (€9.4 billion) in its pharmaceutical division, up 4.4% on the same period last year. The firm attributed this to several of its biological products, not least Darzalex (daratumumab) which grew 57% year-on-year to pull in $774 million in global sales.…

Gilead CA site to house viral vector plant for Kite

Kite will build a 67,000 square-foot facility within its parent company’s site in Oceanside, California to ensure sustainable viral vector supply for its cell therapy products. The Oceanside site will advance viral vector development and supply for both Yescarta (axicabtagene ciloleucel) and its pipeline therapies, according to Kite spokesperson Shant Salakian. “This new facility in Oceanside, CA will be dedicated to the manufacturing of viral vectors and will help ensure we have the capabilities to support a robust and sustainable…

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,…

Cannabis culture: Cronos buys 102,000 L microbial plant from Apotex

The facility in Winnipeg, Canada will be used to produce cell cultured cannabinoids through its collaboration with Ginkgo Bioworks, says Cronos Group. Cannabinoid company Cronos Group has agreed to buy Apotex Fermentation Inc’s 84,000 square-foot biomanufacturing factory in Winnipeg for an undisclosed fee. If the deal closes – expected in Q3 – it will bring Cronos a facility with a combined production capacity of 102,000L, three downstream processing plants, and bulk product and packaging capabilities. The site will support manufacturing…