Therapeutic Class Archives - Page 31 of 53 - BioProcess InternationalBioProcess International

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

by BPI Staff

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’

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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…

IDT Biologika wins 10-year US gov pentavalent vaccine deal

by BPI Staff

IDT Biologika will manufacture five E. coli Master Cell Banks from its Maryland site to support a pentavalent vaccine for the National Institutes of Health (NIH). The National Institute of Allergy and Infectious Diseases (NIAID), part of the US government’s NIH, awarded a 10-year indefinite delivery, indefinite quantity (IDIQ) task order contract to vaccine and drugmaker IDT Biologika. The task order will support a pentavalent vaccine by manufacturing five Master Cell Banks from IDT’s Rockville, Maryland plant, based on the…

CDMO Celonic jumping into cell & gene therapies with €50m plant

by Dan Stanton

Following a €50 million ($56 million) investment in its biomanufacturing capabilities, Celonic is spending a similar amount to propel itself into the commercial cell and gene therapy space. Contract development and manufacturing organization (CDMO) Celonic announced last year the construction of a GMP facility at its site in Heidelberg, Germany, increasing clean room area by approximately 2,000 square meters to support clients’ Phase III and commercial biologics programs. CEO Konstantin Matentzoglu told Bioprocess Insider on stage at BIO that the…

Ohr pushes for oligonucleotide merger with NeuBase

by BPI Staff

Ohr Pharmaceutical has urged its shareholders to vote for a merger with Neubase Therapeutics at a special meeting this week, creating an entity focused on RNA gene silencing. The reverse merger, first announced in January, would create a public company focused on advancing NeuBase’s peptide-nucleic acid (PNA) antisense oligonucleotide (PATrOL) technology platform for the development of therapies to address severe diseases caused by genetic mutations, including Huntington’s disease and myotonic dystrophy. However, the deal is at risk of not going…

Spark on the evolving commercial cell & gene therapy space

by Dan Stanton

Single-use technologies and CDMO expansions have resolved some of the issues in the cell and gene therapy space but analytical and supply chain challenges still exist, says Spark Therapeutics. Spark Therapeutics is one of a handful of companies to achieve regulatory success with an advanced therapy, specifically its gene therapy for inherited vision loss Luxturna (voretigene neparvovec) which received US approval in December 2017. Speaking as part of a panel discussion at the BPI Theater at BIO in Philadelphia last…

Amicus contracts Thermo Fisher to make Batten disease gene therapy

by BPI Staff

Brammer Bio, now part of Thermo Fisher, will provide clinical and commercial manufacturing capabilities for gene therapy developer Amicus Therapeutics. Under terms of the deal, Amicus has teamed with Thermo Fisher to support its intrathecal AAV Batten disease gene therapy programs. The agreement includes production of Amicus’ clinical candidates CLN6 and CLN3, with production set to be transferred to Thermo Fisher’s manufacturing sites in Alachua, Florida, and Cambridge, Massachusetts The contract is “a significant next step in fulfilling our manufacturing…