Author Archives: Dan Stanton

Internal capabilities ‘the backbone’ of Pfizer’s gene therapy strategy

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With a $500 million facility in North Carolina set to come online this month, Pfizer has lauded its approach to gene therapy development and manufacture. Big Pharma peers Roche and Novartis (via the acquisitions of AveXis and Spark, respectively), have achieved regulatory success in the gene therapy field, and Pfizer hopes to replicate similar achievements in the coming months and years. To get there, the firm is following a “three-pronged strategy,†according to Robert Smith – SVP of Global Gene…

December 8, 2021

Doggybone DNA ‘ideal tech’ for pandemic vaccine response, says Touchlight

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Doggybone DNA vaccines can overcome the costly manufacturing limitations of plasmid DNA and the complex formulations and cold-chain issues of mRNA, says Touchlight’s chief research officer. With the successful rollout of Moderna and Pfizer/BioNTech’s respective COVID-19 vaccines, nucleic acid vaccines have shown overwhelming success for pandemic response due to their rapidity of manufacture and induction of robust immune responses, but limitations remain. “Most nucleic acid vaccines are mRNA-based, which induce high titers of neutralizing antibodies (nAb) but lower induction of…

December 6, 2021

Danaher and COVID: $2bn orders for 2022 without potential Omicron windfall

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COVID-19 continues to drive bioprocess orders for Danaher Corporation, but the extended vaccine rollout and the unknown impact of the Omicron variant could see a further surge in 2022. In April, Danaher spoke about its efforts in the manufacture of COVID-19 vaccines and therapeutics, adding an estimated $2 billion in 2021 revenue to its bioprocess businesses Cytiva and Pall. As 2022 appears over the horizon, CEO Rainer Blair told delegates at the Evercore ISI Annual HealthCONx Conference orders for COVID-related…

December 6, 2021

Downstream dealmaking: Donaldson buys Solaris, Ecolab closes on Purolite

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Filtration firm Donaldson Company has acquired Solaris Biotechnology to bolster its presence in the life sciences space. Meanwhile, Ecolab has completed the $3.7 billion acquisition of purification firm Purolite. Minneapolis-based filtration firm Donaldson will add a range of bioreactors, fermenters, and tangential flow filtration systems through the €41 million ($47 million) addition of Italy’s Solaris. “This acquisition is an important step on our journey towards strengthening our presence in the life sciences market,†said Tod Carpenter, CEO of Donaldson. “With…

December 2, 2021

Fujifilm to invest $500m+ in UK CDMO business

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Fujifilm Corp has confirmed £400 ($532) million of a previously announced investment program will be spent expanding its CDMO operations in Billingham, UK. According to a plan unveiled today Fujifilm will double the sites development and manufacturing capabilities, establish both a viral gene therapy facility and a mammalian cell culture facility and create up to 350 jobs. Fujifilm Diosynth Biotechnologies will also build a cell culture facility and ramp up antibody-based therapeutics production capacity through the addition of four 2,000…

December 2, 2021

Regeneron moving fast to assess Ab cocktail for Omicron variant

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Regeneron says it can adapt its COVID-19 antibody cocktail to be effective against the Omicron variant if necessary, thanks to lessons learned the first time around. Omicron was the word of the day at the Evercore ISI HealthCONx Conference yesterday, as drug companies assess the potential impact of the recently discovered variant. One company that spoke about its efforts against the new strain was Regeneron, which has been at the forefront of therapeutic development against COVID-19 with its antibody cocktail…

December 1, 2021

Omicron variant disrupts Thanksgiving for COVID vaccine firms

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Moderna says it will know whether its current mRNA vaccine protects against the Omicron variant within two weeks. Discovered in South Africa last week, the B.1.1.529 variant – named Omicron – has become a concern in the fight against COVID-19 due to its large number of mutations. “[There are] at least 30 in the spike protein alone, with nine of them known to be associated with immune escape and another 11 predicted to be associated with immune escape. You bring…

November 29, 2021

Switzerland flexing its CGT muscle with a little help from Novartis and Roche

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Heavy investment in R&D and manufacturing capabilities is driving the Swiss advanced therapy space but challenges including the skill-deficit still exist, says consultancy firm Coulter Partners. As interest in cell and gene therapies (CGTs) grow, certain hubs are arising globally. Philadelphia’s ‘Cellicon Valley’ and Texas both come to mind, but across the pond Switzerland has been subject to numerous investments and the sector is blossoming. “Switzerland remains a highly attractive location for biopharma in general, due to the fiscal situation,…

November 24, 2021

Scaling-up AAV production? Take your time to develop best processes

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The lack of standardization surrounding gene therapy production means process design can be more important than speed to clinic, says Oxford BioMedica’s CCO. The complexities of manufacturing monoclonal antibodies (mAbs) has been ironed out somewhat over the 30+ years of their presence commercially. But for the burgeoning gene therapy sector, there are no standardized mammalian-based platforms, for example, nor tried-and-tested upstream and downstream processes. “Viruses and viral vectors come in many shapes and sizes, each with their own characteristics,†Dave…

November 23, 2021

CureVac reallocating failed COVID vax capacity to support next-gen mRNA

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Having abandoned its COVID-19 candidate CVnCoV, CureVac has switched up its manufacturing network in preparation for a second-generation messenger RNA (mRNA) vaccine. For the third quarter 2021, German biotech CureVac reported a loss of €143.5 million ($162 million) – a €106.4 million increase compared to the same period in 2020. According to the firm, the increase was in line with high development costs of CVnCoV, the firm’s first-generation mRNA vaccine targeting COVID-19. This was propped up due to a change…

November 22, 2021