An expert from Pharmatech Associates offers a glimpse into the evolution of CM and previews a lively discussion during the upcoming CPhI North America event.
The US will play a key role in the development of advanced manufacturing technologies, predicts a report commissioned by CPhI North America ahead of the 2022 show.
Catalent has announced a multi-year $350m investment at its facility in Bloomington, Indiana, to expand biologics drug substance and drug product manufacturing capabilities.
Quay Pharma, a contract development and manufacturing organization (CDMO), has signed a contract with drug development specialist, Liveome, in relation to the Korean firm’s live biotherapeutic program.
Germany has made a series of contracts with vaccine manufacturers to reserve mRNA manufacturing capacity in the country as part of its pandemic preparedness plans.
US company Catalent is acquiring the UK’s Vaccine Manufacturing and Innovation Centre in Harwell: a facility which had been planned to support COVID-19 and wider vaccine production and which is still under construction.
The US Food and Drug Administration (FDA) has granted commercial licensure approval for Novartis’ Durham, N.C. site, a multi-product gene therapy manufacturing facility, which will start producing Zolgensma immediately.
eTheRNA Manufacturing, a specialist RNA process developer and manufacturing member of the eTheRNA group, has introduced a new lipid nanoparticle (LNP) formulation, development and production service.
CytoImmune Therapeutics, a clinical-stage immunotherapy company developing a novel class of engineered natural killer (NK) cell-based cancer therapies, has announced the opening of its clinical cell manufacturing facility in Toa Baja, Puerto Rico.
The Cell and Gene Therapy Catapult (CGT Catapult) has today published the ‘National Cell and Gene Therapy Vision for the UK’, a document outlining recommendations for a national strategy for the adoption of cell and gene therapies.
Moderna has finalized a strategic partnership with the Australian government to build an mRNA manufacturing facility in Melbourne: which is expected to produce up to 100 million mRNA respiratory vaccine doses annually.
A California based biotech has tripled its capacity to manufacture GMP grade induced pluripotent stem cells (iPSC) space through the expansion of its contract development and manufacturing (CDMO) facility.
Nutcracker Therapeutics, a biotech developing RNA therapeutics using its proprietary biochip-based manufacturing platform, has raised $167m in Series C financing: allowing it to expand and advance its pipeline of mRNA medicines for cancer and further...
Vibalogics, which was recently acquired by Swedish company, Recipharm, says the completion of its expansion project at its facility in Germany boosts capacity and further enhances its flexibility, minimizing time to clinic for customers.
mRNA pioneer Moderna has entered into a Memorandum of Understanding with the Government of the Republic of Kenya to establish an mRNA manufacturing facility in the country.
Charles River recently announced the expansion of its plasmid DNA and viral vector development and manufacturing capabilities in Europe; it says the move is to support the growing need of customers and to safeguard future supply.
A consortium of nine development and finance institutions have announced a partnership with South African vaccine manufacturer Biovac to support its manufacturing expansion.
A global biomanufacturing training hub will be established in Korea to serve low- and middle-income countries wishing to produce biologicals such as vaccines, insulin, monoclonal antibodies and cancer treatments.
Valneva has been awarded up to £20m ($27m) in R&D funding from Scottish Enterprise: which will be used to revive its plans to increase vaccine manufacturing in Scotland.
CDMO Piramal Pharma Solutions will expand capabilities of its Antibody-Drug Conjugate (ADC) facility in Grangemouth, Scotland; and invest in new Active Pharmaceutical Ingredient (API) infrastructure at its Morpeth, England facility.
Over the last 18 months, Aceto has made a series of manufacturing acquisitions, allowing it to better serve customers in biopharmaceutical, vaccine and pharmaceutical industries. It is now investing in several of its newly-acquired North American facilities:...
Orgenesis and The Johns Hopkins University will construct a cell and gene therapy processing facility for point of care treatment of patients at Johns Hopkins.
Performance Cell Manufacturing, a CDMO with a focus on manufacturing cell therapies, has been acquired by Great Point Partners and will now operate under the name Cellipont Bioservices.
Samsung Biologics will manufacture AstraZeneca’s COVID-19 long-lasting antibody combination (AZD7442) and cancer immunotherapy product from next year under an expanded partnership.
Moderna and the Australian government have announced an agreement in principle to build a mRNA vaccine manufacturing facility in Victoria, Australia: providing up to 100 million doses a year.
This month saw BioCina officially open its new biologics manufacturing facility in Adelaide, Australia, flagging it as the only TGA, EMA, Health Canada and US-FDA approved commercial facility of its kind in the country.
Fujifilm Irvine Scientific, Inc, is to build a new bioprocessing center in China, with the goal of ensuring local cell culture media optimization support for vaccines, advanced therapies, and biotherapeutic drug development.
Genezen, a cell and gene therapy focused CDMO, has just opened a new process development and analytical lab, a build that represents the first phase of a 75,000+ square foot cGMP-compliant lentiviral and retroviral vector production facility in Indianapolis.
GreenLight Biosciences and CDMO Samsung Biologics have announced a partnership agreement, with Samsung Biologics to manufacture GreenLight’s messenger RNA COVID-19 vaccine candidate at commercial scale.
To further support the increasing number of pharma companies investing in microbials, Lonza is expanding its microbial development laboratories at its Visp, Switzerland site by 50%.
Culture Biosciences, a company enabling biotech firms to develop and scale manufacturing processes in the cloud, recently announced an $80m Series B round, taking the funds it has raised to date to $100m+.
Waters Corporation and Sartorius are partnering with the aim of providing bioprocess experts with direct access to high-quality mass spectrometry (MS) data to accelerate the speed and improve the accuracy of biopharmaceutical process development.
A leader from Medicines for Europe will share with CPhI Worldwide attendees a look at medicine production and offer solutions for elevating the industry.
During CPhI Worldwide, leaders from two organizations will outline how CM is taking off, potential benefits, and how to clear common obstacles to adoption.
BioNet and Sartorius’ BIA Separations are collaborating on production process development of mRNA vaccines: today announcing an optimized mRNA manufacturing process.
Construction of Samsung Biologics’ new facility is on track, with the CDMO saying pre-sales activities are ongoing for Plant 4, as it is known, despite the challenging business environment amid the COVID-19 pandemic.
