Therapeutic Class

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…

IDT Biologika wins 10-year US gov pentavalent vaccine deal

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

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

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

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

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…

Catalent Novavax deal ups Paragon gene therapy footprint by 65%

The $18 million acquisition is a drop in the ocean compared to the Paragon Bioservices buy but demonstrates Catalent’s appetite to push ahead in the gene therapy space. The $18 million (€16 million) deal sees contract development and manufacturing organization (CDMO) Catalent – through its gene therapy unit Paragon – take over the leases of two facilities in Rockville and Gaithersburg, Maryland from vaccine firm Novavax. All related manufacturing equipment and over 100 of Novavax’ employees will transfer to Paragon.…

AbbVie: Lack of Botox biosimilars a factor in $63bn Allergan buy

AbbVie, a firm all too familiar with biosimilar threats, says the low risk of Botox competition was a factor in its decision to acquire Allergan. The agreed $63 billion (€55 billion) megamerger with Allergan strengthens AbbVie’s pharma assets and provides the firm with a healthy growth platform, Bioprocess Insider reported last week. Allergan’s lead product neurotoxic protein Botox (botulinum toxin) brought in $3.6 billion in sales revenue in 2018 and will add immediate add scale to AbbVie in neuroscience, as…

ambr alert: Sartorius vessel specialized for cell & gene therapies

Sartorius has launched an ambr 250 vessel for cell and gene therapy applications it says taps into industry’s transition from adherent to suspension cell culture formats. Sartorius Stedim Biotech (SSB) has added to its range of ambr 250 modular benchtop bioreactor systems with a single-use vessel designed to accelerate the process development of cell and gene therapy applications, before scaling-up into single-use bioreactors and bags. Existing ambr mammalian vessels are often used for process development of monoclonal antibodies (MAbs) in…

Bluebird’s gene therapy latest to feel ‘inevitable’ teething problems

Bluebird Bio’s $1.8 million gene therapy Zynteglo is the latest such therapy to suffer from manufacturing issues, causing a delay to its EU launch. The European Medicines Agency (EMA) approved orphan drug Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) – previously known as LentiGlobin – as a one-off treatment for beta-thalassaemia in June. Developer Bluebird Bio has priced the therapy at €1.58 million ($1.8 million). However, a setback due to manufacturing problems means Bluebird is delaying launch to at least…