Author Archives: Dan Stanton

Samsung BioLogics to establish US footprint with development labs

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Korean CDMO Samsung BioLogics will open labs in either the Boston or San Francisco area early 2020 on the back of demand for its development services. In 2017, Samsung BioLogics added the ‘D’ to its contract development and manufacturing organization (CDMO) credentials by announcing plans to offer customers cell line and process development (PD) services on top of its well-established clinical and commercial production services. In the 18 months since launching these services, the South Korean firm has undertaken 33…

September 18, 2019

BWB startup pitch: Biopharm America’s got talent

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Secure health data services firm Bowhead Health has won a startup pitch competition run jointly by the Xcelerate and Biopharm America conferences. Bioprocess Insider brought live commentary of the event at Biotech Week Boston. Presided over by seasoned journalist Mike Ward from the EBD Group, twelve participants – well, eleven as one didn’t show – pitched their startup healthcare focused companies in four-minute slots on stage at Biotech Week Boston. Last week’s event, a collaboration between Xconomy’s Xcelerate conference and…

September 17, 2019

Lundbeck adding migraine ‘blockbuster’ and Ab capabilities in $2bn Alder buy

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Danish biopharma Lundbeck says it expects to launch the potential blockbuster migraine biologic eptinezumab early next year after agreeing to buy Alder BioPharmaceuticals. The cash deal, expected to close in Q4 2019, is worth $1.95 billion (€1.78 billion) and falls into Lundbeck’s “expand and invest growth strategy†announced by the Danish biopharma firm in February 2019, aimed at expnding its breadth in brain disease therapies and rebuilding its pipeline. Since then the firm acquired Abide Therapeutics, adding a serine hydrolases…

September 17, 2019

GE and Germfree in modular gene therapy manufacturing collaboration

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GE Healthcare has teamed with cleanroom production firm Germfree to develop a modular biomanufacturing facility for emerging biotherapeutics and gene therapies. Bioprocess vendor GE Healthcare is no stranger to modular manufacturing platforms, with the likes of Bayer, Pfizer and Lonza all opting for its off-the-shelf KUBio platform modular biologics factory. Furthermore, to date 63 manufacturers have selected the firm’s FlexFactory bioprocess platform, which uses predominantly single-use technology. And now the company has partnered with Florida-based Germfree to co-develop a new…

September 17, 2019

AGC Biologics to exit Berkeley CA plant by end of year

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AGC Biologics is undertaking major expansions at sites in Seattle, Denmark and Japan, but the plant in Berkeley no longer fits with the CDMO’s growth strategy. The Berkeley, California clinical biomanufacturing plant will play no further part in the firm’s future, AGC Biologics management told Bioprocess Insider, and will be shut by the end of the year. “Berkeley was no longer the right fit for AGC Biologics,†said CEO Patricio Massera, and so the lease will not be extended into…

September 16, 2019

Coming of phage: BiomX building clinical plant

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BiomX has announced plans to construct a clinical facility in Israel capable of making host bacteria in a 20-40 liter bioreactor for the production of bacteriophages. The facility in Ness Ziona, Israel will primarily be used to manufacture clinical supply of BiomX’s candidate BX002 as it enters the clinic as a potential treatment for inflammatory bowel disease (IBD). The candidate is a phage; a virus that infects and replicates within a bacterium. Such therapies were used extensively in the Soviet…

September 13, 2019

CGT CMC: Plan ahead, avoid comparability studies says Novartis

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Making changes to the manufacturing process for cell and gene therapies is possible but cumbersome due to the need to perform comparability studies, says a Novartis veteran. Speaking at the Cell & Gene Therapy Bioprocessing & Commercialization conference – part of Biotech Week Boston – this week, Novartis’ Sergio Fracchia advised developers of advanced therapies to think about their manufacturing needs several years in advance to avoid future pitfalls. Specifically, Fracchia – who serves as Global regCMC Director, Cell and…

September 11, 2019

Scancell adds first partner for high potent MAb tech

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Immuno-oncology firm Scancell has begun offering its AvidiMab technology to partners looking to increase the potency of their monoclonal antibody pipelines. Scancell has its own pipeline of monoclonal antibodies (MAbs) targeting novel cancer treatments, but this deal represents the first collaboration with an external partnerover its AvidiMab technology. “AvidiMab is proprietary technology to enable the modification of the constant region (FC) of a human antibody to allow direct tumor killing of antibodies directed to tumor associated antigens (TaGs) but may…

September 11, 2019

ABEC breaks plastic ceiling again with 6,000 L single-use bioreactor

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ABEC has launched a single-use bioreactor system with a working volume of 6,000 L – three times that of industry’s standard upper limit. While single-use bioreactors are a staple in the industry these days, one of the commonly discussed limitations of such systems in a commercial setting are their size. Most vendors offer bioreactors of 2,000 L as their upper limit leaving biomanufacturers to either run several systems in unison or opt for stainless-steel tanks if requiring larger volumes. But…

September 11, 2019

Boston T-Cell Party? News from #BiotechWeekBoston

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Industry has convened in Boston this week to celebrate the success of biotech and discuss the bioprocesses of the future. Bioprocess Insider brings together the best of social media as Bioprocess International, Biopharm America and the Cell & Gene Therapy congress combine for #BiotechWeekBoston.

September 10, 2019