Cellectis chooses Lonza to take on the clinical manufacturing of its UCART blood cancer immunotherapy candidates, intended to be marketed as industrialized, readily available CAR-T cells.
GSK’s biopharmaceutical manufacturing facility will be focused on the company’s pipeline of biologic medicines, including gene therapies, and vaccines.
CGT Catapult adds six additional clean room spaces to its Stevenage manufacturing center, to aid companies readying themselves for clinical and commercial manufacture.
‘Talk to your CDMO early’ is the advice BioConnection gives to developers of biopharmaceuticals, suggesting that they make a reservation to ensure availability.
Unofficial reports suggested that individuals in Tanzania were exhibiting Ebola-like symptoms, but the WHO reports not receiving detailed information from the country.
McKesson partners with TrakCel aiming to address the supply chain challenges of cell and gene therapy developers in late stages of development or approaching commercialization.
Merz announces that it has completed the construction of a new plant for its botulinum neurotoxin product and unveils a ‘robot-controlled’ filling line.
Four pharma companies are providing half of the investment required for ‘world’s largest genetics project’, in return for access to the genomic data generated.
The seventh #NLSDays event saw the latest trends in fields including ATMP, clinical evolution, and R&D technologies, find their audience in Scandinavia.
Lonza’s facility in Singapore will provide Celltrion with the drug substance product to meet demand for the latter’s Remsima biosimilar in the European and US market.
Atelerix to work on the development of gel stabilisation technologies enabling room temperature storage of Rexgenero’s cell therapy candidate, under an Innovate UK grant.
The Alliance for Regenerative Medicine released a ‘Statement of Principles’ on gene editing, as controversy over the technology’s potential rumbles on.
The FDA approves an IND application from ActoBio for AG017, an oral biologic drug candidate for the reversal of celiac disease, a condition which currently has no approved treatments.
UK government invests further in businesses manufacturing advanced therapies, opening a fund for companies working on technology to improve commercial production.
Asia’s largest integrated insulins facility, operated by a subsidiary of Biocon in Malaysia, receives GMP compliance certification from Ireland’s HPRA.
Themis obtains an exclusive licence from Merck to develop vaccine candidates with an undisclosed indication, using its measles virus vector-based platform.
Pfizer invests half a billion dollars to expand its gene therapy manufacturing facility in North Carolina and enhance its position to compete in the booming market.
The US HSS will provide funding to Merck for a year’s supply of its investigational Ebola vaccine for use in DR Congo to combat the repeated outbreaks of the virus.
Merck enters a clinical collaboration agreement with Oncologie to evaluate the combination of investigational drug Bavituximab and Keytruda in cancer patients.
The increasing number of cell and gene therapies in clinical development is evolving the supply chain into a ‘supply cycle,’ says TrakCel CEO, with service providers being called to maintain control under pressure.
Revance Therapeutics says developing a Botox biosimilar is “challenging, but not impossible” in reply to AbbVie’s dismissal of the prospect of a copy of the blockbuster coming to market.
Sanofi warns that the World Health Organization’s delayed strain selection will push back the date on which it delivers vaccines for the 2019-2020 flu season.
The FDA approves targeted biologic, Dupixent, for the treatment of atopic dermatitis in patients 12 to 17 years old, the first treatment of its kind for adolescents.
New data on the genetic biomarkers impacting the development of cancer treatments has been released creating the largest publicly accessible dataset of its kind.
Lonza extends its deal with Omeros for the commercial manufacture of a treatment for thrombotic microangiopathy, ahead of filing with the US FDA and the EMA.
Celltrion has partnered with Nan Fung Group to create Vcell Healthcare, which will manufacture and commercialize three of Celltrion’s biosimilar products in China.
The summer months are traditionally slow on movements across the industry, but July saw a number of manufacturing partnership deals take place as companies look ahead to product commercialization.
Lonza already manufacturers three out of five commercially available ADCs but is preparing for additional demand with a two-year expansion project at its Visp site.
AveXis and BIA Separations announce an agreement for the commercial purification process of SMA gene therapy drug Zolgensma and further gene therapy candidates.
Janssen aims to expand the label of delivery in the US and EU for its product, Darzalex, to include subcutaneous delivery through the use of Halozyme’s technology.
Catalent Biologics works with Novartis to develop and manufacture its SMA gene therapy treatment and provide manufacturing capacity, as the treatment enters the market.
