Author Archives: Gareth Macdonald

Oxford Biomedica working to optimize vector production platform

Oxford Biomedica is optimizing its vector production system to boost yields and accelerate production in response to growing demand. The UK gene and gene therapy firm and contract development and manufacturing organization (CDMO) talked about efforts to improve its vector production platform last week during its Q4 presentation. The main aim – according to chief scientific officer Kyri Mitrophanous – is to increase viral vector production capacity and remain competitive. “We continue to invest in the lentiviral vector platform in…

Preparation key to gene therapy commercialization, MilliporeSigma

Gene therapy firms are under pressure to get to market quickly according to an expert from MilliporeSigma, who says process development and tech transfer are significant hurdles. The ability to treat – or cure – disease at the genetic level in a targeted manner is an attractive proposition for drug companies. The challenge now is to make these therapies in a cost and time efficient manner according to Ratish Krishnan, associate director for cell and gene therapy bioprocessing at Milliporesigma.…

Thermo Fisher to buy PPD to build in ‘high growth’ clinical services sector

Thermo says buying PPD will position it as leader in the “high growth” CRO sector and help it win more business from new and existing customers. Thermo Fisher Scientific announced its intention to buy contract research organization (CRO) PPD for $17.4 billion in a statement on Thursday, citing demand from pharma and biotechnology sector customers. Thermo Fisher’s CEO Marc Casper said “The acquisition of PPD is a natural extension for Thermo Fisher and will enable us to provide these customers…

BPI West: Modular tech key to rapid COVID-19 vaccine development

The coronavirus pandemic has underlined the benefits of modular manufacturing according to an expert who says the approach has been key to accelerating vaccine production. SARS-CoV-2, the virus that causes COVID-19, was first isolated in December 2019 and sequenced a month later. The first vaccines against it were developed, tested, and approved about a year after the first was identified. The record speed with which industry created the COVID-19 shots is testament to vaccine industry efforts, according to John Yoshi…

Resilience adds CDMO Ology to growing manufacturing footprint

Five months after launching, Resilience has acquired Ology Bioservices bagging a facility in Florida. The 200,000 square feet of biomanufacturing space joins a growing footprint, which includes a plant in Fremont, California subleased from Orchard Therapeutics. Financial details regarding the acquisition have not been disclosed, but Ryan Flinn, a spokesman from Resilience told us the addition of contract development and manufacturing organization (CDMO) Ology brings more than 200,000 square feet of mostly biologic drug substance manufacturing space, along with 300…

CGT firms making progress but manufacturing remains a hurdle, says analyst

Cell and gene therapy developers have yet to address delivery, production and safety challenges but progress is being made. The conclusion came from RBC Capital Markets, which published analysis of trends in the cell and gene therapy sectors this week. According to executives quizzed by the market research firm, the biggest challenges that modern gene therapy firms face are pretty similar to those encountered by pioneers in the field a couple of decades ago. “Gene therapies hold considerable promise in…

Lifecycle approach could cut cell and gene therapy costs

Cell and gene therapy firms should consider a ‘lifecycle approach’ to process development and manufacturing to reduce cost of goods, says ElevateBio. Developing cell and gene therapies is highly complex. Such work requires specialist skills and hard to make materials like vectors, the lack of capacity for which has been raised as a constraint in the scientific and mainstream press. But cell and gene therapy firms also need to keep commercialization in mind according to Mike Paglia, COO at cell…

BARDA to give Emergent another $23m for tech after J&J jab mix-up

BARDA to give Emergent Biosolutions an extra $23 million for new tech after plant mix up ruined millions of doses of J&J’s single-shot COVID vaccine. The facility in question is Emergent’s plant in Baltimore, Maryland which made the news after it emerged the contract development and manufacturing organization (CDMO) had mistakenly mixed ingredients of the J&J jab with those of the AstraZeneca shot, rendering 15 million doses unusable. The incident prompted the Biden administration to place Johnson & Johnson in…

Biotech and CDMOs need to evolve to support innovate therapies, says Ilya Pharma

CDMOs and the cell and gene therapy sector need to evolve to support the increasing number of innovative therapies entering trials, says Ilya Pharma. Ilya CEO Evelina Vågesjö made the comments about innovative therapy manufacturing after the Sweden-based biotech released first-in-human (FIH) trial data indicating ILP100 – a bacteria-based therapeutic candidate designed to treat chronic wounds – shortens healing time by six days. “We have evaluated multiple CMOs [contract manufacturing organizations] for clinical material production and commercial supply already and…

CDMO and COVID delays push back Vaxcyte’ pneumococcal vaccine IND

Vaxcyte will file VAX-24 pneumococcal conjugate vaccine later than planned citing capacity constraints at CDMO Lonza and the COVID-19 pandemic. The California biotech had intended to file the vaccine for US FDA review early this year, however, according to its Q4 results presentation, submission is now planned during the first half of 2022. Vaxcyte said it expects to submit an IND application “between January and June 2022 and plans to announce top-line data from the ensuing Phase I/II clinical study…