Manufacturing

A well-defined contamination control program is essential to maintain quality through aseptic manufacture of parenteral drug products.

Bioprocessing advances improve product yield, cut costs, and streamline integration between upstream and downstream processes.

The ASTM standard describes how to evaluate single-use systems for foreign particle analysis.

Supplier of punches and dies to tablet producers, I Holland, has reported that it will be revisiting its webinar series, investigating best practices in tablet manufacture, for those currently working from home.

The new cell-line producing platform enables fully scalable production of high-performance adeno-associated virus vectors.

The goal of the collaboration is to manufacture up to one billion does per year of mRNA-1273, Moderna’s vaccine against the novel coronavirus.

Sartorius adds chromatography systems and resins, tangential flow filtration, and biomolecular characterization technologies.

Catalent and Johnson & Johnson announce joint investment and tech transfer to prepare for rapid scale-up and segregated cGMP commercial manufacturing capacity.

Solentim and ATUM will bundle together the Leap-In Transposase platform with the VIPS single cell cloning instrument for cell line development.

MilliporeSigma’s Bio4C Software Suite combines process control, analytics, and plant-level automation.

With funding from the Bill & Melinda Gates Foundation, Batavia’s low-cost vaccine manufacturing process will be used to produce Wistar’s drug substance and drug product formulations, to be distributed to vaccine manufacturers.

NIH trial shows remdesivir accelerates recovery; Gilead study shows similar efficacy for 5- and 10-day dosing.

Merck will provide funding and will work with researchers at the Institute for Systems Biology to identify targets for therapeutic intervention and vaccine development.

A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.

The vaccine will be based on a ReiThera-proprietary simian adenoviral vector with strong immunological potency and low pre-existing immunity in humans.

Emergent will offer up its drug substance manufacturing services with support by investments from Johnson & Johnson starting in 2020.

Wavelength Pharmaceuticals expanded production of APIs for certain pharmaceutical products needed to manage respiratory critical care patients in the COVID-19 pandemic.

Analyzing process and equipment data provides insights that can improve quality and productivity of pharmaceutical manufacturing.

The company will build an additional commercial-scale, contract manufacturing facility for viral vectors and gene therapies near its existing site in Carlsbad, CA.

Through the agreement, BARDA will support the advancement of the vaccine candidate to FDA licensure and will handle all late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020.

The International Safe Transit Association’s Pharma Committee published a guideline on the passive thermal packaging qualification process.

Dutch company HALIX has announced it is joining a consortium of partners that are all under the guidance of the University of Oxford to provide good manufacturing practice (GMP) manufacturing services for a COVID-19 vaccine.

This milestone achievement will allow the companies to move forward with developing a GMP-compliant manufacturing process for clinical testing.

The technology center is dedicated to developing greener, safer chemistries for manufacturing pharmaceutical raw materials and intermediates.

Civica Rx plans redundant manufacturing capacity to relieve and prevent shortages of generic, sterile injectable drugs.

ISPE’s Facility of the Year Awards for 2020 go to bio/pharma companies in eight award categories, including two winners in the new Social Impact category.

This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.

Advanced analytics and modeling can be used to predict downstream failures, allowing for corrective action before batches are lost.

As the coronavirus pandemic unfolds, Pharma must practice science over hype.

With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.