Analytics

The companies will collaborate to develop and manufacture Grid’s lead therapeutic candidate for the treatment of solid tumors.

Industry experts were honored for business, scientific, and social contributions.

In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested.

Inadequate endotoxin testing places patients at risk. Knowing the relative strengths and weaknesses of available test methods is crucial to maintaining quality and safety.

Forced degradation tests, conducted in early development stages, can provide insight into degradation pathways and products of a drug substance.

Join experts from SGS and Thermo Fisher Scientific to hear how to improve workflows for confident extractable and leachable studies. Live: North America: Tuesday, Oct. 31, 2017 | 11am EDT | 10am CDT / Europe: Tuesday, 7 Nov., 2017 | 9am GMT | 10am CET / On Demand available after airing until 7 Nov., 2018. Register free: http://www.pharmtech.com/pt_w/analytical

AbbVie will pay a $205-million upfront payment and have the option to develop and commercialize two antibody targets globally.

The new BioLive event, which will be a global hub for biopharmaceutical manufacturing, will launch alongside CPhI Worldwide 2018 in Madrid.

ABEC, an equipment and engineering company, will provide a custom-made, single-use bioreactor to custom manufacturing firm, Emergent, for its Maryland manufacturing facility.

The biopharmaceutical company has received a $4.2-million grant from the Bill & Melinda Gates Foundation to invest in the development of new treatments for Enterotoxigenic Escherichia coli infections, a bacterial cause of diarrhea in the developing world.

The $72-million investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

The companies aim to use CureVac’s proprietary messenger RNA technology to develop and commercialize up to five potential cancer vaccine products.

The new center will serve as a regional hub where scientists and engineers can work with customers for biological development.

Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.

The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.

The company announced plans to expand its viral vector process development facilities in the United States and its cleanroom facilities in the Netherlands for vector-based products.

Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity.

The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.

The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.

Fluence Analytics’ Argen is a protein and polymer stability monitoring product that uses continuous light scattering measurements to produce an information stream.

Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.

AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.

Johnson & Johnson’s Janssen Sciences Ireland UC will invest more than EUR 300 million (US$355 million) to expand manufacturing capacity for biologic medicines at its Ireland facility.

Clariant’s Tri-Sorb Desiccant Tablets are designed for USP moisture testing of blister packs.

Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.

Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.

The Thermo Scientific Pharma mini implant line is an integrated solution built around the Thermo Scientific Pharma mini HME twin-screw micro compounder.

An updated version of Shimadzu’s LabSolutions analytical data system incorporates additional functions to comply with data integrity regulations, and to support development and quality inspection procedures.