Manufacturing, Biologic Drugs

The new bioLIVE event, launching this year with CPhI Worldwide 2018, will explore innovation in bioprocessing and manufacturing with a focus on the roles of innovative methods and technology for biopharma continuous manufacturing.

The companies will work together to discover, develop, and commercialize immunotherapies for patients with solid-tumor cancers in a collaboration worth $695 million per program.

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

A collaboration using Pall’s bioprocessing technology in G-CON’s PODs enables flexible continuous bioprocessing and viral vector facility solutions.

GE Healthcare, Cobra Biologics, and the Centre for Process Innovation (CPI) have entered into a collaboration to advance manufacturing of adeno-associated virus vectors for gene therapy.

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

Cell-line quality has a significant impact on biologic drug quality; learn more about this and other upstream challenges at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

FDA awarded nearly $3 million in grants for continuous manufacturing and other advanced manufacturing technologies as part of the agency’s efforts to ensure a robust and reliable supply of biological products.

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

The biopharmaceutical company will invest approximately $800 million to expand facilities and manufacturing capacity at its campus in Rensselaer County, NY.

Colin Clarke, from the National Institute for Bioprocessing Research and Training, will lead a four-year project for enhancing upstream biopharmaceutical manufacturing process development through single cell analysis.

The provider of plant-based ingredients will present recently launched multi-compendial materials for upstream and downstream biopharmaceutical applications.

The new features on the purifier deliver additional sizes and sterilization/sanitization compatibility.

The collaboration will focus on developing manufacturing solutions for biosimilars.

Bio-Rad introduces CHT Ceramic Hydroxyapatite XT media and Nuvia HP-Q resin resin for process protein purification.

New products were developed as next-generation process intensification technologies, MilliporeSigma reports.

The company is increasing manufacturing capacity at its Copenhagen, Denmark facility with the addition of six new bioreactors.

A collaboration integrates Sartorius Stedim Biotech’s BIOSTAT STR bioreactors and Repligen’s XCell ATF cell-retention control technology to create simplified, scalable equipment for intensified cell culture.

A multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.

The SciLog SciPure FD System from Parker Bioscience is an automated single-use system for the filtration and dispensing of products into either bottles or bags.

Single-use technologies, modular systems, and robots are on the rise.

Immobilizing the antibodies on a solid-phase support, such as a resin, and carrying out the conjugation of the payload-linker while the antibodies are bound to that support will prevent aggregation at its source.

The company is certified as a manufacturer of pressure vessels and components for use in China.

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.

Dompé Farmaceutici’s Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.

The company’s purpose-built facility in Norwich, United Kingdom specializes in plant-based expression of proteins, metabolites, and complex natural products.

FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.