Manufacturing

Prequalified manufacturing suites could benefit from a new business model, say some industry executives.

The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

NIH announced positive safety results from the vaccine, VSV-ZEBOV, and found that all patients in the study experienced a strong antibody response.

This article presents first-hand perspectives from industry users to suppliers of single-use sensors.

The author explores various biocontainers-both old and new-in the single-use space.

Making the switch from batch to continuous manufacturing requires a thorough understanding of the process.

Ethylene vinyl acetate (EVA) drug-release technologies are explored.

Second-generation needle-free injection systems will make parenteral drug administration more convenient, efficient, and safe.

As an affiliate member, TraceLink brings serialization expertise to the Pharma & Biopharma Outsourcing Association.

A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.

Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.

Drug makers back alternative to FDA labeling update rule.

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.

Genentech plans to invest more than $125 million in an expansion of its fill/finish facility in Hillsboro, OR.

Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.

Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.

The new 2000-L bioreactor will double Rentschler’s single-use manufacturing capabilities.

WuXi's new US facility will manufacture CAR T-cell therapies and other cancer immunotherapies.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

Drug spending rose last year at the highest rate since 2003, driven by specialty medicines, according to a report from pharmacy benefit manager Express Scripts.

The agency will employ a ring vaccination method similar to the one used to eradicate smallpox.

The upgrades will offer the opportunity for higher product yields and higher purity levels.

It is important to understand degradation and processing to maintain product stability in biologics.

Sessions address cell therapies, serialization, contract services, and more.