Manufacturing

New technologies in the digital factory enhance quality, efficiency, and flexibility for bio/pharmaceutical manufacturing.

HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.

A monoplant may offer greater supply security and flexibility for specialist medicines.

Containment valves and smart monitoring can keep employees safe and improve manufacturing efficiency when handling potent APIs, intermediates, and solid-dosage drugs.

Single-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.

While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.

Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.

The Pulse-Flow PTA dense phase pneumatic conveying system from Gericke USA directs air or nitrogen into the pressure vessel and pipeline in timed, regular pulses that form the dry material into separate, wavelike, pulsed slugs.

Eli Lilly and Company experts share the vision and the value of the digital plant for pharmaceutical manufacturing.

System connectivity and data analysis drive increased productivity in pharma manufacturing.

The Coalition for Epidemic Preparedness Innovations (CEPI) and CureVac partner to develop a transportable mRNA vaccine manufacturing platform.

The $21.4-billion acquisition will create stand-alone business within Danaher’s life-sciences portfolio.

ACG Group highlighted its expanded footprint in Brazil through the launch of a new capsules manufacturing plant in Pouso Alegre-Minas Gerais.

Mustang intends to combine an oncolytic virus with an interleukin-13 Rα2-(IL13Rα2)-specific chimeric antigen receptor to potentially enhance efficacy in treating glioblastoma multiforme.

Teva will apply Insilico’s technology for predictive biomanufacturing to create more efficient biomanufacturing processes.

Suppliers address complex supply chains for global biopharmaceutical manufacturing using disposable components.

As demand increases, new materials and machines broaden options for blister packaging.

The company will invest an additional $60 million to expand its manufacturing facility in Durham County, NC.

Ireland’s National Institute for Bioprocessing Research and Training received funding from the Science Foundation Ireland’s Technology Innovation Development Award program for monoclonal antibody research.

The “hands-on” seminar will be held June 12–13, 2019 and will feature educational sessions and demonstrations in the company’s process laboratory.

The partnership will expand Lonza’s offering of hematopoietic cell lines.

The Society of Plastics Engineers (SPE) Extrusion Division will host the SPE Minitec-PLUS polyethylene terephthalate (PET)/polylactic acid (PLA) Extrusion, a two-day event at the Polymers Center in Charlotte, NC, on May 1–2, 2019.

GS1, a global supply-chain standards organization, launched a new messaging standard in collaboration with GS1 US to help meet the requirements of the US Drug Supply Chain Security Act (DSCSA) for salable returns of serialized prescription drugs.

In a partnership with Thermo Fisher Scientific Pharma Services, Pacira added a manufacturing suite in Swindon, UK, that doubles the company’s capacity by mirroring the company’s facility in San Diego, CA.

The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.

Supply chain players are eligible to participate in FDA’s pilot program to develop an electronic system for tracking drug products.

Honeywell introduces Aclar Accel barrier film with faster production and delivery for pharma packaging.

The agency is requiring companies that make sartan blood pressure drugs to review their manufacturing processes due to the problem with impurities.

PCI Pharma Services expanded capacity of its commercial packaging site in Illinois.

In a deal potentially worth up to $460 million, Genentech and Xencor will develop and commercialize novel cytokine therapeutics.