APIs and Excipients

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.

Dow’s portfolio of solutions for pharmaceutical applications now includes products from Dow Corning’s silicone technology platform.

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.

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.

Europe updates the guideline on excipients information in labeling and packaging.

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.

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.

Compared to traditional drug discovery approaches, drug repurposing, repositioning, and rescue can be faster and cheaper.

Sartorius begins building a new, EUR 30-million (US$35.2 million) Cell Culture Technology Center in Ulm, Germany.

CDMOs have established strategies for handling new chemical entities with unknown biological activity.

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

This article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.

Omya will be presenting its functionalized calcium carbonate for several applications at the show.

Solid state solutions provider Holodiag and fine chemical R&D provider Holochem join forces.

Additional reactor capacity and a wastewater processing plant increase API manufacturing capacity at the Cambrex site in Kalskoga, Sweden.

ADC Bio announces plans to expand into clinical and commercial drug manufacturing for ADCs.

BASF will build a new specialty amines plant at its existing wholly owned site in Nanjing Chemical Industry Park in China.

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.

Drug repurposing, repositioning, and rescue can be faster, cheaper, and target more diseases than traditional drug discovery approaches.

Roquette has completed its previously announced acquisition of Itacel, an excipient division of Blanver.