Author Archives: Dan Stanton

Think your CMO is high maintenance? Let’s hope so

Having a well-managed facility maintenance schedule can avoid lengthy shutdowns and lost revenues, says a regulatory expert. During the Q2 2019 reporting season, Samsung BioLogics reported revenues of KRW 78.1 billion ($65 million) compared to KRQ 15.1 billion recorded in the previous quarter. The Korean contract manufacturing organization (CMO) attributed the 38% drop to the plant operation rate temporarily decreasing at its 152,000 L plant number 2 during the quarter due to “regular maintenance essential for biopharmaceutical manufacturing.” According to…

US Gov provides Merck extra $23m for Ebola vaccine

The Health and Human Services (HHS) funding will support continued development of V920, a live viral vectored vaccine designed to protect against Zaire Ebola virus, says Merck. Merck & Co. began developing a vaccine to protect against the Ebola virus following the 2014-2016 Ebola outbreak in West Africa. In 2017, the firm received a definitive contract funded by the Office of the Assistant Secretary for Preparedness and Response of the HHS, originally worth $126 million (€114 million), to aid development…

Pfizer pumps $500m into NC gene therapy site

The expansion in North Carolina will create 300 jobs and is the latest investment by Pfizer in its burgeoning gene therapy network. The $500 million (€450 million) investment in Sanford, North Carolina will see the Big Pharma firm construct a facility to support production of its recombinant adeno-associated virus (rAAV) vectors for use in its gene therapies and vaccines. Mike McDermott, president of Pfizer Global Supply, said the Sanford expansion will “strengthen Pfizer’s leadership in gene therapy manufacturing technology” and…

Evotec eyes US commercial biomanufacturing pod

Months after buying platform firm Just.Bio, Evotec says it is evaluating the construction of the first modular J.POD for commercial manufacturing later this year. In May, German R&D services firm Evotec launched itself into the large molecule space through the $90 million (€81 million) acquisition of Just.Bio. The deal added several platform technologies aimed at reducing the cost of goods for proteins, including a large molecule manufacturing design platform, known as J.DESIGN and JP3, a lab and computational tool for…

New Zealand? Firm eyes US ops to prep for commercial peptides

Zealand Pharma has taken its first steps to build US commercial operations with an aim to launch four peptides over the next five years. According to Zealand Pharma CEO Emmanuel Dulac, the Danish biotech has “one of the most predictive and promising platforms” in the therapeutic peptide space, and 20 years of discovery and R&D are rapidly approaching fruition. “We have proven that we can take multiple programs through the clinics and execute on them according to industry benchmarks. To…

From zero to $250m: Agilent aims to dominate cell analysis space

With potentially three acquisitions within nine months, Agilent Technologies has rapidly grown its presence in the cell analysis space and says it aspires to grow further. Technology and services firm Agilent entered the bioanalysis space in 2015 when it acquired manufacturer of instruments and assay kits Seahorse Bioscience. Over the past nine months, Agilent has upped its position in the sector through the purchase of ACEA Biosciences, swiftly followed by the acquisition of Luxcel Biosciences , and just last month…

Dyadic: Deals stack up as industry looks to ‘game-changing’ expression system

Another quarter of deal making by Dyadic International demonstrates how companies are looking to microorganisms instead of CHO to produce affordable drugs, the firm says. Numerous biopharma and biotech firms over the past few years have been turning to Dyadic International to access its C1 fungus-based expression system. The second quarter 2019 was no exception, with Luina Bio, Alphazyme, and the Serum Institute of India inking separate agreements with Dyadic within a two-week period. Such deals reflect Dyadic’s long-term vision…

Orchard to open CA plant in 2021 to support gene therapy pipeline

Orchard Therapeutics says it will balance its existing CMO network with a planned facility in Fremont to create the infrastructure needed to commercialize its gene therapies. Orchard’s pipeline of ex vivo autologous gene therapies include the former GSK hematopoietic stem cell (HSC) gene therapy Strimvelis – approved by the EMA in 2016 – and five clinical stage programs. The firm has been reliant on its network of contract manufacturing organizations (CMOs) to produce these therapies, but late last year it announced it…

Sartorius (cell) banks on mammalian manufacturing

Sartorius Stedim Biotech says its newly launched mammalian cell bank manufacturing offering fits hand-in-hand with its existing cell line development services. German bioprocess vendor Sartorius has grown its contract testing and manufacturing services over the past few years, not least through the acquisition of analytics and product characterization firm BioOutsource in 2015. Now the subsidiary Sartorius Stedim BioOutsource will offer the manufacture of GMP master and working cell banks (MCB/WCB) for mammalian suspension cells from its site in Glasgow, UK.…

CMOs to continue picking up Big Pharma non-core facilities

Recent facility acquisitions by Lonza and Catalent show Big Pharma is divesting its non-core assets in a trend that is set to continue, according to PharmSource. In the previous couple of months, contract manufacturing organizations (CMOs) Lonza and Catalent have both increased their production networks through facility acquisitions. Lonza’s expansion incorporates a sterile, multi-product drug product facility in Stein, Switzerland, acquired from fellow Swiss firm Novartis. Catalent, two weeks prior, added its first biologics plant outside the US through a…