Manufacturing

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

In a roundtable Q&A with biopharma executives, the vulnerability and challenges of dealing with extractables and leachables in single-use bioreactor bags are explored.

The companies will collaborate on the development of vaccines to expand GeoVax’s cancer immunotherapy program.

The IFPAC annual meeting on advancing the understanding and control of manufacturing processes using process analytical technology will be held Feb. 11-14, 2018.

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

The Industrial Internet of Things can be used in the bio/pharmaceutical industry to monitor equipment health, optimize processes, and enable modular facilities.

PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.

Proper selection and installation optimizes fluid system performance.

Closures that protect solid-dosage drugs and the capping equipment that applies them have new product-protecting features.

Measurements by a drone-based online pressure monitoring system help identify weak points in the filling line, enabling the process to be optimized.

The Wilden Quattroflow QF10k size pump from PSG, a Dover company, has been designed to fill the gap between the existing QF4400/5050 and QF20k pump sizes.

Sterile-molded filling assemblies from AdvantaPure are suited for single-use vial and syringe filling.

SupaPore Junior cartridge filters from Amazon Filters are suited for low flow up to 2m3/Hr of fluids and 100Nm3/Hr of gas processes, and are available in 2.5- and 5-in. sizes.

Ross, Charles & Son’s four-gallon model PDDM-4 planetary dual disperser is suited for vacuum operation, mixing thick slurries and highly-filled pastes. Ross, Charles & Son’s four-gallon model PDDM-4 planetary dual disperser is suited for vacuum operation, mixing thick slurries and highly-filled pastes.

Bio/pharma professionals manage expectations amid industry uncertainty.

Will business decisions and drug pricing policies help or hinder science and drug approval advances in 2018?

Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the US Drug Supply Chain Security Act serialization deadline.

A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.

Everyone may not be ready for the deadline, but open standards based on GAMP and GS1 will soon be released; more companies are also leveraging what they’ve learned from serialization to improve overall efficiency.

The biotechnology company has filed for FDA approval of a new plasma manufacturing facility in Covington, GA, to support its immunology franchise.

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

Implementation of the Packaging Serialization Standard cuts serialization costs, shortens deployment time, and expedites compliance with anticounterfeiting regulations.

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

FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.

MilliporeSigma will collaborate with IPS and G-CON to offer end-to-end, turnkey, modular MAb manufacturing.

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, have 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.

MJR PharmJet's MicroJet Reactor technology is a continuous process for producing nanoparticles with tightly controlled particle size and particle size distribution.

The company is seeking approval from FDA for use of the drug, migalastat, to treat Fabry disease in patients who have amenable mutations.