BioPharm Products

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

SciLog Select Go Single-Use Assemblies from Parker Hannifin uses an assortment of validated parts and assemblies to build needed devices for biopharmaceutical manufacturing.

MasterControl has added three new cloud-based analytical solutions to its MasterControl Version 11.7 software for clinical managers and regulatory/submissions professionals.

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

Bormioli Rocco Pharma offers new packaging solutions for powdered oral drugs, parenteral drugs, pediatric syrups, and protein-based drugs.

The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

Supply Chain Wizard has developed a set of integrated digital solutions to improve supply chain functions.

Cole Parmer's Masterflex L/S Cytoflow pump head is suited for use in biopharma and microbiology applications.

Qosina's Y connectors are manufactured from plastisol and produced through a dip-molding process.

An updated version of Shimadzu’s LabSolutions analytical data system features an operating environment for complete data management and security in networked laboratories.

The Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, is compliant with good distribution practices and comes in three models.

Wyatt Technology has added the DynaPro Plate Reader III to its macromolecular and nanoparticle characterization product offerings.

ABEC, an equipment and engineering company, will provide a custom-made, single-use bioreactor to custom manufacturing firm, Emergent, for its Maryland manufacturing facility.

Almac Group’s Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, is available in the United States.

The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.

Fluence Analytics’ Argen is a protein and polymer stability monitoring product that uses continuous light scattering measurements to produce an information stream.

Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.

AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.

Gelest, a manufacturer and provider of silane, silicone, and metal-organic compounds, released a range of dual-function poly(ethylene glycol) (PEG) reagents that enable new approaches to PEGylation for bioconjugates.

Groninger will showcase its FlexPro 50 line for small batch production at CPhI Worldwide 2017, and present on up- and downstream processes with freeze-dryer developer and manufacturer Martin Christ.

DoKaSch Temperature Solutions, a Germany-based provider of climate-controlled air cargo containers, announced that its Opticooler air cargo containers are now available in the United States.

The new purification resin is expected to improve monoclonal antibody purification capacity by up to 40% due to its high binding capacity.

Single-use and single-pass TFF devices are facilitating advances in biopharma manufacturing.

Steris added the Amsco 430LS and 630LS sterilizers to its line of medium steam sterilizers.

The acquisition adds sterile manufacturing capability to the CDMO’s services, which include API formulation and manufacturing.

Higher-flow peristaltic pumps from Watson-Marlow Fluid Technology Group are designed for upstream and downstream bioprocessing with single-use fluid path assemblies.

ABEC increases the maximum capacity of its Custom Single Run Bioreactors to 4000 L, doubling the industry standard.

Quattroflow’s EZ-Set Pump Chamber Replacing System for its single-use pumps allows users to change chambers quickly by hand.

Sartorius Stedim Biotech expanded its range of single-use membrane chromatography solutions with Sartobind Cassettes.