Author Archives: Dan Stanton

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…

Swiss site opens to boost Novartis CAR-T production

Novartis has opened a CHF 90 million ($91 million) manufacturing site in Stein, Switzerland to support its cell and gene portfolio. In August 2018, Novartis announced a Swiss facility would support production for its burgeoning chimeric antigen receptor T cell (CAR-T) products and pledged CHF 90 million in phased investments to support the project. The facility in Stein, about 20km east of Basel, opened its door last week ahead of the predicted 2020 date, bolstering the firm’s global network. “The…

Astellas: Large-scale gene therapy plant major driver in $3bn Audentes deal

Gaining clinical and commercial manufacturing capabilities through the acquisition of Audentes will reduce reliance on third-party manufacturers in the gene therapy space, Astellas says. Japan’s Astellas increased its presence in the gene therapy space yesterday by announcing plans to buy San Francisco-based Audentes Therapeutics for approximately $3 billion (€2.7 billion) in cash. The deal, expected to close in the first quarter 2020, will add Audentes’ lead candidate AT132 – a Phase I/II clinical-stage experimental treatment for X-linked myotubular myopathy (XLMTM)…