Manufacturing

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.

The revised USP Chapter 1207 gives best practices for obtaining reliable data in container closure integrity testing.

Amid corporate restructurings, regulatory initiatives, and aging R&D assets, will drug development accelerate or stall in 2016?

The Ross AMK Kneader Extruder combines the technologies of a double-arm mixer with an extrusion screw.

The BioClamp Plastic Tri-Clamp, from BioPure Technology, part of the Watson-Marlow Fluid Technology Group, is a patented plastic union tri-clamp meant to reduce distortion on polymeric fittings when subjected to heat.

Mass Spec Lab, a privately owned analytical company, announced its official launch on Dec. 28, 2015 in Southern California.

Boehringer Ingelheim announced it will establish a new biopharmaceutical production facility in Vienna.

Samsung BioLogics begins construction on their third facility in Songdo, Korea.

GENEWIZ signs definitive agreement to acquire Beckman Coulter's gene services business.

Recipharm has signed an agreement with Sweddish pharmaceutical company LIDDS for the production scale up and manufacture of LIDDS’ Liproca depot for the treatment of prostate cancer.

The agency has launched a new web platform to foster scientific innovation.

Collaboration between users and suppliers to increase understanding, clearly define user requirements, and mitigate risk is facilitating acceptance by industry and regulators.

Quotient Clinical announced on Dec. 16, 2015 that is has acquired Co-Formulate Limited.

Capsugel adds clinical trial and commercial manufacturing, as well as particle engineering services with two acquisitions.

Rockwell Automation’s updated PlantPAx DCS enhances automation and control.

Millipore Express PHF hydrophilic, sterilizing-grade filters from EMD Millipore offer faster flow rates to speed the process or reduce the process footprint.

Grand River Aseptic Manufacturing expands disposable technology capabilities at aseptic facility.

AstraZeneca partners with the Wallenberg Center for Protein Research to conduct studies on the Secretome.

PSL has installed several advanced contained filtration and drying facilities as part of an expansion of a pharmaceutical manufacturing plant in Singapore.

Ajinomoto Althea expands biological drug product manufacturing operations to include ADCs.

Sandoz announces that the European Medicines Agency has accepted a MAA for a biosimilar of etanercept.

Catalent has entered into an exclusive long-term supply agreement to produce Pfizer’s OTC proton-pump inhibitor for heartburn treatment, Nexium 24HR (esomeprazole), which is also marketed as Nexium Control outside the US.

FDA released an interim response to AbbVie’s citizen petition on the labeling of biosimilars.

TxCell signs strategic agreement with MaSTherCell for European manufacturing of its cell therapy products.

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.

Paragon Bioservices entered into a contract with the International Aids Vaccine Initiative for the process and analytical development and cGMP manufacturing of an HIV vaccine candidate.

Biogen, Genentech, Johnson & Johnson, Novartis, and Patheon publicize their support for action on climate change.

Seqirus, CSL Limited’s influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.

Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.

All openings and potential apertures for air penetration must be considered when designing a cleanroom so that the HVAC system can maintain the desired negative or positive pressure.