Manufacturing, Biologics

Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.

The new Acquity Arc Bio System by Waters is specifically engineered to enable efficient transfer and improvement of bioseparation analytical methods.

The company will invest $139 million in sterile manufacturing technology at its facility in Ballytivnan, Sligo, Ireland to support the growth of its oncology pipeline.

The funding from the Walloon Region will enable Univercells to start developing a manufacturing platform aimed at driving down costs of biosimilars manufacturing.

Lonza Pharma & Biotech's's Modular Automated Sampling Technology (MAST) platform, which allows for the collection of up to 10 sterile sample sources for automated analysis in multiple analytical devices, won the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing.

GE Healthcare will equip Cellular Biomedicine Group's cell therapy manufacturing facility in Shanghai, China, with its FlexFactory single-use platform, designed to speed up cell therapy manufacturing timelines.

A new target for the treatment of multiple myeloma using CAR-T technology was discovered by researchers at Osaka University.

Sartorius Stedim Biotech will equip Abzena’s contract development and manufacturing facilities in Bristol, PA, and San Diego, CA, with single-use equipment and scale-up technologies.

The companies aim to develop a potential zinc finger protein transcription factor-based gene therapy for treating Lou Gehrig’s disease.

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.

Proper selection and installation optimizes fluid system performance.

Advances in TFF and single-use systems help advance UF/DF on the continuous processing path.

The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).

FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.

BioTek Instruments has released a second edition of its BioSpa software that now offers users a simplified but effective interface for kinetic imaging or detection workflows.

Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, has filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.

In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.

FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Lonza has entered into strategic license agreements for exclusive rights to a gene-therapy platform for developing treatments for hearing and balance disorders.

The company has opened a new California facility that, combined with its existing site in Foster City, CA, will quadruple its laboratory footprint for gene therapy products.

Single-use systems provide replaceable fluid paths.

A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.

The Biomanufacturing Technology Roadmap is accelerating innovative manufacturing strategies for biopharmaceuticals.