Author Archives: Dan Stanton

Lonza adding capacity to service Servier and high microbial demand

As it expands capacity in Switzerland, Lonza says demand for antibody fragments, scaffolds and bioconjugates services is driving microbial manufacturing. Contract development and manufacturing organization (CDMO) will add a sixth microbial manufacturing facility at its biopark in Visp, Switzerland, currently under construction. The 3,000 L scale microbial facility will be used to service an extended manufacturing agreement with Servier, producing the asparaginase-based active pharmaceutical ingredient (API) for its acute lymphoblastic leukemia (ALL) therapies. Speaking with Lonza directors Clemens Jakobi and…

Robust first half results as Repligen feels COVID-19 tailwinds

A robust quarter included a ramp-up in COVID-19-related orders, something Repligen says will set the scene for increased revenues in the second half of 2020. “Our results for the second quarter and through the first half of 2020 have been stellar,” Repligen CEO Tony Hunt told stakeholders last week. “We delivered overall revenue growth of 25%, including organic growth of 19% in the second quarter.” This equates to $164 million for the first half, compared to $131 million over the…

Moderna on $1.3bn manufacturing scale-up of mRNA COVID vaccine

Moderna is confident of attaining 500 million doses of its COVID-19 vaccine candidate after using proceeds from a stock offering to scale-up manufacturing at its site in Massachusetts and at CDMO Lonza. In May, Moderna Therapeutics raised $1.3 billion through the sale of shares. According to the prospectus, the funds were to be used for “raw materials, labor and capital equipment purchases related to the manufacturing of mRNA-1273,” Moderna’s messenger RNA vaccine candidate in late-stage trials for COVID-19. This money…

Staying single: Lilly looks to optimize antibody manufacturing for COVID-19

Eli Lilly is testing several antibodies in its efforts against COVID-19 but says a monotherapy, if successful, would help optimize manufacturing. Eli Lilly has several potential therapies in the clinic attempting to take on COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus. But speaking during the firm’s second quarter financial call last week, chief scientific officer Dan Skovronsky said the two programs he is most excited about are virus neutralizing antibodies for the treatment and prevention of COVID-19 are…

Merck betting on ‘swish-and-swallow’ and single administration COVID vaccines

A recombinant vesicular stomatitis virus-based COVID-19 vaccine may be active when administered orally, says Merck as it begins clinical manufacture from facilities in Pennsylvania. Merck & Co. (known as MSD outside North America) entered the battle against COVID-19 relatively late, inking a triumvirate of deals in May. Two of the programs focused on vaccine development, one of which – a collaboration with non-profit research organization IAVI – is expected to begin clinical studies in the next few months. The program,…

MolMed latest add-on for expansion hungry AGC Biologics

AGC Biologics has acquired Molecular Medicine (MolMed), increasing its presence in the CDMO space and adding a pipeline of cell and gene therapy candidates. In March, contract development and manufacturing organization (CDMO) AGC Biologics launched a voluntary tender offer to acquire Italian cell and gene therapy developer and manufacturer MolMed for €240 million ($284 million). Today the deal has been completed, bulking out AGC’s biopharma offering. On the services side, AGC adds two GMP sites in Milan and Bresso, both…

GSK confident traditional vaccine tech has major role in COVID-19 efforts

The headline-makers in the race to develop a COVID-19 vaccine are not the traditional firms, but GSK says its proven adjuvant approach will set its offering apart. During GlaxoSmithKline’s (GSK’s) second quarter financial call, an analyst from Wolfe Research pointed out the vanguard of COVID-19 vaccines were not being developed and made by the big three traditional vaccine firms: GSK, Merck & Co., and Sanofi. Chinese efforts aside, the frontrunners dominating the media coverage are AstraZeneca/University of Oxford’s effort based…

ABC news: Lonza to scale-up ophthalmic therapy for Kodiak

CDMO Lonza will use its global network, including a dedicated facility in Switzerland, to produce Kodiak Sciences’ antibody biopolymer conjugate (ABC) KSI-301. KSI-301 is an anti-VEGF biopolymer conjugate being developed by Kodiak Sciences for various ophthalmic retinal diseases. The candidate is in Phase II/III studies for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), and as the firm looks to commercialization it has inked a deal for manufacturing scale-up with Lonza. The contract development and manufacturing organization…

Pfizer blasts Trump’s pricing plans, threatens to pull US investments

CEO Albert Bourla says Pfizer will rethink plans to invest in US R&D and manufacturing after lambasting four executive orders aimed at reducing drug prices unveiled last week. Like most areas of society, Big Pharma’s relationship with US President Donald Trump has been tumultuous. Initial fears of a clampdown on drug pricing through promises to ‘drain the swamp’ were abated through Trump cozying up with the sector once in office. And reforms passed by Congress in 2017 through the ‘Tax Cuts…

COVID-19: ‘Pandemic-ready’ set-up placing Emergent apart in CDMO space

Emergent BioSolutions is at the frontline of COVID-19, supporting vaccine candidate production for AstraZeneca, J&J, and others. Head of Emergent’s CDMO business explains why. Before January, the biologics contract development and manufacturing organization (CDMO) landscape was “very, very exciting,” Syed Husain, senior vice president and CDMO business unit head at Emergent, tells Bioprocess Insider over a Zoom interview. On the drug substance side, there was a healthy amount of demand for capacity coming from industry with a lot of opportunities…