Analytics

Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.

In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.

The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.

The Endress+Hauser iTHERM TrustSens hygienic RTD self-calibrates to verify in-line that the sensor is working as designed

The agency has approved Nucala (mepolizumab) to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) to GlaxoSmithKline. This indication is the first FDA-approved therapy specifically to treat EGPA.

SGS has introduced a Sanger sequencing service at its Glasgow, United Kingdom, laboratory to support genetic stability testing and perform identity testing on cell banks, plasmids, and viral seeds/vectors.

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.

Medherant has developed an improved instrument for testing drug release from transdermal patches.

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.

The Hiden ExQ quantitative gas analyzer is a mass spectrometer system providing continuous on-line analysis of dynamic gas streams at pressures from sub-atmospheric up to 30 bar.

The InMotion Karl Fischer (KF) Oven Autosampler from Mettler Toledo is suited for KF titration and comes in two models, InMotion Flex and InMotion Pro, and allows up to 26 samples to be analyzed on a 25-centimeter platform.

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.

Binding Site has introduced a number of new monoclonal antibodies targeting infectious diseases, including cytomegalovirus, hepatitis (A, B, C, and D), herpes, human immunodeficiency virus (HIV), rubella, and toxoplasma.

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.

Understanding what affects a measurement and implementing appropriate procedures will aid weighing accuracy.

Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

MasterControl has added three new cloud-based analytical solutions to its MasterControl Version 11.7 software for clinical managers and regulatory/submissions professionals.

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

The use of therapeutic vaccines presents a new way to manage diseases, such as cancer and sexually transmitted diseases.

Company completes first successful run of what is believed to be the largest synthesis-scale done for oligonucleotide APIs.

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.

The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.

CDMO Celonic acquired a biomanufacturing facility in Heidelberg, Germany from Glycotope.