Author Archives: Dan Stanton

Back to school: GE and UMass partner on academic viral vector plant

GE Healthcare has partnered with UMass to establish a viral vector manufacturing facility – its latest tie-in with academia in the cell and gene therapy space. The planned facility at the University of Massachusetts (UMass) Medical School’s Worcester campus will provide recombinant adeno-associated virus (AAV) vectors for preclinical research. High demand and a shortage of capabilities for viral vectors means the 3,220 square-foot facility, decked out with GE Healthcare’s viral vector FlexFactory platform, will help alleviate the current wait researchers…

Hemophilia A-OK! FTC thumbs up effectively closes Roche’s $4.3bn Spark buy

There is no risk of competitive harm between Roche’s approved hemophila A monoclonal antibody and Spark’s gene therapy candidates, say the US and UK competition bodies. In February, Swiss Biopharma firm struck a deal to buy Philadelphia, Pennsylvania-based Spark Therapeutics for $4.3 billion (€3.8 billion). Now after months of investigation by the US Federal Trade Commission (FTC), Roche is on the verge of closing the deal. The FTC’s concerns centered on the potential competitive harm of overlaps between Roche and…

Samsung BioLogics brings Berkeley Lights’ Beacon to Korea

Korean CDMO Samsung BioLogics will use the Beacon optofluidic platform to reduce cell line development timelines and boost its drug development services. Having first entered the contract development space in 2017, Samsung BioLogics has now inked a deal to use Berkeley Lights’ Beacon pre-programable and automated optofluidic platform to service its customers cell line and process development projects. The technology itself is based on a nanofluidic chip consisting of chambers in which cells are placed to be cultured and assayed,…

WuXi Biologics establishes microbial fermentation in latest expansion

Having rapidly built up its mammalian biomanufacturing network, WuXi Biologics says it will now add microbial fermentation to its CDMO offering. At the end of October this year, Chinese contract development and manufacturing organization (CDMO) WuXi Biologics announced its latest financing round with intentions to raise roughly HK$3,950 million ($500 million). The supporting document states: “The Company intends to apply the net proceeds from the Primary Placing to support its development of vaccines and microbial based products as well as…

Pfizer latest to cite competitiveness of inhouse gene therapy capabilities

With a surge of gene therapies coming through the clinic and a lack of CDMO capacity, having inhouse capabilities is driving investment and M&A activity. As increasing numbers of gene therapies progress through the clinic and towards commercialization, it is no secret that demand for production capabilities is high. The complexity and cost of making viral vector means is a problem, but a biopharma with its own capabilities holds a major advantage, it would appear, something Pfizer CSO Mikael Dolsten…

GE and Guangzhou gov bring bioprocess training to China

A single-use bioprocessing training facility in Guangzhou will help attract and retain biopharma talent in the burgeoning China market, says GE Healthcare. Bioprocess vendor GE Healthcare Life Sciences and Guangzhou Development District government have invested a total of $10 million (€9 million) to establish a biomanufacturing training center in the Guangdong province in China. The Guangzhou Bioprocess Academy aims to train over 1,000 people annually when it opens in September next year and is needed to feed the the rapid…

Agilent aims to double oligo sales as CO plant comes into play

Agilent Technologies says it hopes to bring in $200 million in oligonucleotide revenues as it ramps up capacity to serve the growing RNAi sector. Agilent Technologies gained a nucleic acid active pharmaceutical ingredients (API) manufacturing base in Frederick, near Boulder, Colorado, in 2006 when it acquired SynPro Corp. In 2016, the life sciences technology and services firm announced plans to double its oligonucleotide capacity through a new $120 million (€108 million) facility at the site. At the Evercore ISI HealthCONx…

$50m deal helps make Sartorius a media player again

A year after ending an exclusive collaboration with Lonza for cell culture media and buffers, Sartorius has reentered the space by acquiring 50% of Israeli firm Biological Industries The deal sees bioprocess equipment and consumables vendor Sartorius pay €45 million ($50 million) in cash to Kibbutz Beit Haemek and private equity fund Fortissimo Capital for just over half of Biological Industries. Under terms of the deal, Sartorius will have the option to acquire a further 20% of the Haifa, Israel-based…

Merck plans $57m NC investment to support rotavirus vaccine

The investment at the facility in Wilson, North Carolina comes on the back of several expansion across Merck & Co’s vaccine manufacturing network. Merck (known as MSD outside of North America) announced just five months ago plans to invest $680 million (€613 million) to ramp up its vaccine production capabilities in North Carolina to support human papillomavirus (HPV) vaccines Gardasil and Gardasil 9. The expansion plans included a $30 million investment to add packaging lines and warehouse space at Merck’s…

Enzyvant hit with CRL due to regenerative therapy manufacturing concerns

The US FDA has cited manufacturing concerns in a complete response letter (CRL) rejecting Enzyvant’s regenerative tissue therapy RVT-802. RVT-802 is a tissue-based therapy in development for congenital athymia. While the candidate has been granted Breakthrough Therapy designation, Rare Pediatric Disease designation, Orphan Drug designation, and Regenerative Medicine Advanced Therapy (RMAT), the US Food and Drug Administration (FDA) has rejected the therapy due to manufacturing concerns. Roivance Sciences subsidiary Enzyvant received the CRL this week and while there were no…