Manufacturing

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.

Market changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain.

Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.

Is there enough talent to go around?

Scientists and industry experts seek effective preventive therapies to combat global disease.

Large-scale implementation of Protein A chromatography offers several challenges.

A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.

Baxter announced that its new biopharmaceutical arm, scheduled to become independent from Baxter in 2015, will be located in Bannockburn, Illinois.

Leased facilities in California will expand Kite Pharma's capacity for T-cell therapies.

The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.

MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

The Berlin-Buch facility will begin manufacture of the company’s immune cell therapy.

The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.

Antibodies in research should be standardized and categorized using a barcode-like classification system, according to research published in Nature.

Juno's new manufacturing facility in Washington state will support clinical trials for immunotherapies.

The new center represents AmerisourceBergen’s first facility erected specifically for clinical trial and commercial third-party logistics activities.

Thermo Fisher Scientific adds Advanced Scientific’s custom single-use systems and equipment to its bioprocessing offerings.