Drug Substance Analysis

Through its Janssen pharmaceutical companies, Johnson & Johnson, has partnered with Theravance to develop and commercialize a therapeutic for inflammatory bowel diseases.

X-ray powder diffraction exploits the interaction between x-rays and matter to study the structural and microstructural properties of materials.

Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.

A different perspective on controlling fixed costs of biomanufacturing, based on know-how from other industries, provides a competitive edge, says the CEO of Samsung BioLogics.

The new Acquity Arc Bio System by Waters is specifically engineered to enable efficient transfer and improvement of bioseparation analytical methods.

Corning will feature its 3D bioprinting technology and tools to support 3D cell culture at booth #1029 during the SLAS 2018 conference on Feb. 3-7, 2018 in San Diego, CA.

Comecar will provide cell culture equipment for biopharmaceutical company CO.DON AG's new production site in Leipzig, Germany.

The acquisition, valued at EUR 520 million (US$631 million), would expand Takeda’s late-stage pipeline in gastroenterology and would extend an already existing collaboration between the two companies.

Graham Reynolds, vice-president and general manager, Global Biologics at West Pharmaceutical Services, Inc., shares insights on key considerations when developing a biologic drug product in a prefilled syringe.

The companies aim to develop a potential zinc finger protein transcription factor-based gene therapy for treating Lou Gehrig’s disease.

The companies aim to discover and develop locked nucleic acid oligonucleotides as orally available therapies for treating inflammatory bowel diseases.

The development of new packaging solutions that are fit for drugs of the future requires close collaboration between the pharmaceutical manufacturer and its packaging suppliers and machine vendors.

The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.

FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.

MilliporeSigma will collaborate with IPS and G-CON to offer end-to-end, turnkey, modular MAb manufacturing.

BioTek Instruments has released a second edition of its BioSpa software that now offers users a simplified but effective interface for kinetic imaging or detection workflows.

Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, have filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

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 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.

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.

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.