As environmental considerations move up the agenda for biopharmaceutical manufacturers, process intensification can offer a win-win situation for those looking to lower costs and improve sustainability.
Process intensification is the natural next step for the biopharma industry as it transitions from a focus on global blockbuster drugs to a diversified portfolio of specialized biopharmaceuticals, finds a study.
The compelling benefits of single-use technologies (SUT) have been demonstrated in bioprocessing for many years. They are deemed to have a role to play in facilitating process intensification through enabling low capital costs and fast change-over time...
Despite continuous bioprocessing being talked about as the future of manufacturing in biologics for years, this has not become reality. However, in recent years, the US government has begun to dedicate funds to intensify the production of biologics.
AstraZeneca's long-acting antibody combination Evusheld has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection: marking the first global marketing approval of...
A study has demonstrated the effectiveness and safety of adalimumab biosimilars Hulio and Hyrimoz in the therapy of patients with inflammatory bowel disease (IBD).
ElevateBio and the University of Pittsburgh have entered into a long-term strategic partnership to accelerate the development of innovative cell and gene therapies: with ElevateBio to locate its next BaseCamp process development and GMP manufacturing...
Employment in Greater Philadelphia among cell and gene therapy companies has more that doubled since 2019, while employees at contract manufacturing organizations have grown by nearly 40%. Continuing to build the workforce will be crucial as the area...
BrainVectis, a subsidiary of AskBio, has received clearance from the French authorities to start a Phase 1-2 clinical trial for its novel Huntington’s Disease gene therapy, BV-101.
The World Health Organization (WHO) has published its first guidelines for Ebola virus disease therapeutics, issuing ‘strong recommendations’ for the use of two monoclonal antibodies.
Pfizer and BioNTech have completed their application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine: saying they stand ready to start shipping...
The WHO has updated its advice on COVID-19 booster doses: including recommendations on which groups should receive a second booster shot and how countries should plan around the upcoming availability of variant-specific vaccines.
San Diego headquartered, Regen BioPharma, has filed a provisional patent application filing covering utilization of dendritic cell technologies to augment efficacy of its patented survivin mRNA cancer immunotherapeutic vaccine.
Bavarian Nordic has entered into an agreement with Grand River Aseptic Manufacturing (GRAM), a US based contract manufacturer, for fill and finish of the Jynneos smallpox/monkeypox vaccine in the country.
EMA has begun its review of the conditional marketing authorization application from South Korean developer, SK biosciences, for its COVID-19 vaccine, Skycovion, a recombinant protein-based vaccine with adjuvant from GSK.
As part of its strategy for growth in the biopharmaceutical industry, Trelleborg Healthcare & Medical will make an investment of several million dollars in expanding its manufacturing facility and BioPharma Center of Excellence in Northborough, Massachusetts....
The U.S. Food and Drug Administration (FDA) has approved bluebird bio’s Zynteglo (betibeglogene autotemcel), also known as beti-cel: a one-time gene therapy custom-designed to treat the underlying genetic cause of beta thalassemia in adult and pediatric...
West Pharmaceutical Services has made an investment in Latch Medical, a Dublin-based company working on next-generation vaccine and biologics delivery technology.
AGC Biologics and RoosterBio have launched a strategic partnership to create an end-to-end solution for the development and production of hMSC and exosome therapeutics.
The AI and QC specialists have joined to use AI and QC in order to discover biological pathways relevant to the treatment of triple-negative breast cancer.
The first Omicron bivalent COVID-19 vaccine has been authorized: with the UK’s regulatory agency giving the green light to Moderna’s Spikevax Bivalent Original/Omicron booster shot.
Merck and Orna Therapeutics have announced a collaboration agreement to discover, develop and commercialize Orna’s next generation oRNA technology across multiple programs, including vaccines and therapeutics in infectious disease and oncology.
Biomanufacturing company National Resilience has announced a strategic collaboration with Mayo Clinic in biomanufacturing to deliver novel biotherapeutics for rare and complex conditions.
The purchase brings under the UPS Healthcare umbrella several temperature-controlled facilities in 14 countries situated throughout Europe and Latin America.
The pharmaceutical company has inked a strategic collaboration with the drug discovery firm, centering on uncovering novel targets in Alzheimer’s disease.
Novartis has set out how it expects biosimilars to affect its business in the coming years, identifying sales of $80bn that are open to its off-patent business and expressing confidence in the ability of some of its own products to weather the arrival...
Charles River Laboratories, International Inc. has received regulatory approval - in the form of Good Manufacturing Practice (GMP) certification - to commercially produce allogeneic cell therapy drug products for distribution in Europe, from the European...
Millipore Sigma has launched its VirusExpress 293 Adeno-Associated Virus (AAV) Production Platform: meaning the CDMO can now provide a full viral vector manufacturing offering including AAV, Lentiviral, CDMO, CTO, and process development.
Teva Pharmaceutical Industries has given a bullish assessment of its chances of claiming a big slice of the Humira biosimilar market, arguing it has “the best product profile of all companies coming to the market in 2023.”
Pfizer is planning to deliver COVID-19 vaccines against two sets of omicron subvariants in the autumn in the belief its “robust manufacturing capabilities” are up to the task.
Biopharmaceutical company Global Blood Therapeutics specializes in conditions that often disproportionately impact underrepresented communities, such as SCD.
BioNTech and Genmab are expanding a global collaboration to develop and commercialize novel immunotherapies for the treatment of cancer patients: with the first monospecific antibody candidate expected to enter clinical trials by the end of the year.
Edinburgh CDMO RoslinCT and Massachusetts CDMO Lykan Bioscience will combine to create a global advanced therapies CDMO: offering significantly expanded manufacturing capacity.
A $76m investment in the facility in Grand Island, New York, will increase capacity to produce raw materials used in manufacture of vaccines and biologic therapies.
Vaxess Technologies has launched a phase 1 trial for its H1 influenza vaccine patch: outlining its mission to increase access to vaccines via the shelf-stable, sustained-release patch.
