Pharmaceutical Technology Editors

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

The companies have partnered to launch Conjugated Polymer Nanoparticle (CPN) products for use in molecular imaging and R&D applications.

The drug particle engineering and nanotechnology company offers a nanotechnology platform that can revive failed drugs in the pharma pipeline.

PCI Pharma Services and CSP Technologies will partner on protective packaging solutions for clinical trials and stability testing.

Colin Clarke, from the National Institute for Bioprocessing Research and Training, will lead a four-year project for enhancing upstream biopharmaceutical manufacturing process development through single cell analysis.

Evonik completed a EUR 36 million expansion of its contract-manufacturing capabilities for API and advanced intermediates in the United States and Germany.

The $425-million acquisition adds formulation development and finished dosage manufacturing capabilities to Cambrex’s existing global API manufacturing network.

FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.

In the second half of CPhI’s annual report, experts review industry trends and warn that trade and patent changes could increase healthcare cost by $100 billion over the next five years.

The provider of plant-based ingredients will present recently launched multi-compendial materials for upstream and downstream biopharmaceutical applications.

Guenter Nadler, director of Business Development at Aptar Pharma, will present an insight briefing on new drug-delivery trends in treating upper and lower respiratory tract issues on Wednesday, Oct. 9, 2018 at CPhI Worldwide.

On Wednesday, Oct. 9, 2018, Dr. Caroline Bauer will discuss selecting technologies that enable the progression of compounds that require bioavailability enhancement to achieve target absorption at CPhI Worldwide.

Researchers from Ruhr-Universität Bochum in Germany and the National Institutes of Health modified the protein Nurr1 to enter cells from the outside, possibly enabling the protein to become a drug development candidate for illnesses such as Parkinson’s disease.

Researchers at Vanderbilt University Medical Center have isolated the first human monoclonal antibodies (mAbs) that can neutralize norovirus, a virus that causes acute gastrointestinal (GI) illness.

The companies will develop therapies targeting the in-vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform.

FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.

Avara Pharmaceutical Services acquired Sandoz’s sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada.

At CPhI World-Wide 2018, Bosch will display its Xelum R&D for laboratory-scale continuous OSD production and its new data-mining service for equipment and process troubleshooting.

August Faller will demonstrate boxes for expanded communication space, smart packaging, and tamper-evident labels.

The agency approved AstraZeneca’s Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia.

Gerresheimer started producing its Gx RTF ClearJect cyclo-olefin copolymer syringes in Germany and will exhibit at CPhI WorldWide 2018.

New manufacturing and control technologies are being explored.

The new features on the purifier deliver additional sizes and sterilization/sanitization compatibility.

The collaboration will focus on developing manufacturing solutions for biosimilars.

The agency approved Teva Pharmaceutical’s Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence.

FDA Commissioner Scott Gottlieb, MD, issued a statement regarding new warning letters FDA issued to Chillin Mix Kratom and Mitra Distributing, companies marketing kratom, a potential source of opioids, with unproven medical claims.

Gore’s new flexible freeze containers are designed to protect high-value drug substances from container breakage or leakage.

The collaboration will explore the potential of Dyadic’s gene-expression platform to produce multiple biologic vaccines and drugs.

ICS distribution center will serve manufacturers of specialty medications, biosimilars, and cell and gene therapies.

Bio-Rad introduces CHT Ceramic Hydroxyapatite XT media and Nuvia HP-Q resin resin for process protein purification.