November 23rd 2024
The Thousand Oaks, Calif., cell therapy manufacturing facility now houses new production suites, updated development labs, and more after expansion.
The $3.6 million investment will allow the CDMO to boost its advanced labeling, automated visual inspection, and fill/finish capabilities.
November 22nd 2024
Sanofi will use this investment to increase its antibody bioproduction at its site in Lyon Gerland, France.
November 21st 2024
The companies will collaborate to create and test circVec DNA–LNP formulations for use in potential therapeutic applications.
November 20th 2024
SEKISUI has used a £15.7 million (US$20.7 million) investment to expand its clinical-grade drug substance manufacturing at its UK site.
Industrializing Cell and Gene Therapies at Discovery Labs
Joerg Ahlgrimm is now leading The Discovery Labs’ mission to establish a powerhouse for cell and gene therapy development and manufacturing in the Philadelphia area.
Orgenesis Completes Koligo Acquisition and Gains Icellator Technology in Related Transaction
Orgenesis has completed its previously announced acquisition of Koligo Therapeutics with the additional acquisition of Tissue Genesis’ cell isolation technology, Icellator.
Bringing Six Sigma to Preclinical Pharma R&D
Branching out from roots in industrial biotechnology, Riffyn Data Systems (and its CEO Tim Gardner) is taking the message of data-driven process improvement to biopharma.
Due Diligence Assessment of CMC Activities
For planned acquisitions or licensing, a careful analysis of CMCl factors is vital to ensure no problem areas are overlooked.
UK Biotech Investment Continues to be Strong, According to Data
Recent data, from BIA and Clarivate, has revealed that investment in UK biotech continues to be strong.
The Elephant (or Donkey) in the Room
European pharma companies may have a vested interest in the outcome of the US elections.
Vaccine Developers Pledge to Stand with Science
As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.
Labs on the Frontlines: Balancing Re-Entry and the Race to a COVID-19 Cure
How real estate can accelerate productivity as life sciences companies prioritize COVID-19 therapeutics, vaccines, and new diagnostics R&D amidst new guidelines.
Axol Bioscience Appoints Liam Taylor as CEO
The company has appointed Liam Tayler as CEO to guide the growth of the company’s iPSC technologies, products, and services.
Patentability Considerations for Antibody-Related Inventions
Stringent patentability requirements present a challenge to obtaining broad-based antibody claims, so companies should develop a strategy based on multiple reinforcing layers of protection.
Commercialization Poses Challenges for Cell and Gene Therapies
The early success seen on the market for approved cell and gene therapies poses both technical and manufacturing challenges for pipeline candidates on the road to commercialization.
CanSino Vaccine Produces Immune Response
Study reports immune and T-cell response from CanSino COVID-19 vaccine candidate.
mRNA Vaccine Produces Immune and T-cell Response
Preliminary data from a German Phase I/II trial shows Pfizer/BioNTech COVID-19 vaccine candidate produces immune response.
VAR2 Pharmaceuticals Wins MilliporeSigma’s Advance Biotech Grant
VAR2 Pharmaceuticals has been selected for its development of a drug-conjugated malaria protein that potentially selectively binds to most human tumor types.
Sartorius Stedim Biotech Launches Consultancy Services for Viral Clearance Validation
The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.
FDA Cites Travel Restrictions in CRL
Nabriva Therapeutics reports that FDA says travel restrictions are preventing the on-site inspection of a European contract manufacturer.
FDA Revokes EUA for Hydroxychloroquine
Citing clinical trial data that hydroxychloroquine did not show benefits for COVID-19 patients, FDA removes emergency use authorization for the drug as a treatment for the novel coronavirus.
Novavax Secures $60 Million in Government Funds
Novavax announces DoD contract to produce 10 million doses of COVID-19 vaccine candidate.
Are We All In This Together?
Achieving herd immunity will require testing, data, a vaccine, and public support.
Ajinomoto Bio-Pharma Services, Humanigen in Manufacturing Agreement for COVID-19 Biologic
The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19.
Novavax Acquires Praha Vaccines, Expands Large-Scale Vaccine Manufacturing Capacity
The acquisition gives Novovax an annual operating capacity of more that one billion doses of COVID-19 vaccine antigen.
NIIMBL Funds Projects with $10 Million for Advances in Biopharma Manufacturing Innovation
This latest round of funding adds 14 new technology projects, workforce development, and Global Health Fund projects to NIIMBL's portfolio.
mRNA Vaccine Shows Positive Interim Phase I Results
Participants in two dosing cohorts in Moderna’s mRNA-1273 study reached or exceeded neutralizing antibody titers generally seen in convalescent sera.
Catalent, Arcturus Therapeutics Sign Vaccine Deal
Catalent will manufacture a mRNA-based COVID-19 vaccine for clinical trials and potential commercialization.
How Fast Is Too Fast?
Will moving at “warp speed” to develop a vaccine impact efficacy or safety?
Remdesivir Approved for Emergency Use
FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.
Catalent to Manufacture J&J’s Lead COVID-19 Vaccine Candidate
Catalent and Johnson & Johnson announce joint investment and tech transfer to prepare for rapid scale-up and segregated cGMP commercial manufacturing capacity.
Studies Report Effectiveness of Remdesivir
NIH trial shows remdesivir accelerates recovery; Gilead study shows similar efficacy for 5- and 10-day dosing.
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options.
J&J Ramps Up COVID-19 Vaccine R&D
Johnson & Johnson announces clinical trial plans for COVID-19 vaccine candidate, as well as plans to produce 1 billion vaccine doses.