API Synthesis and Manufacturing, Large Molecule

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.

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.

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.

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

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

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

Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing. 

The addition of 20,000 sq. ft. of manufacturing and office space increases Avecia’s Milford, Ma, oligonucleotide capacity to 3.0 mol.

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.

Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.

As of mid-December, less than half the number of new drug approvals were issued by FDA in 2016 compared with 2015.

AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.

Clinical biotechnology company Moderna Therapeutics will build an integrated clinical manufacturing facility for mRNA production in Norwood, Massachusetts.

Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.

Enzymatic catalysis offers pharma manufacturers a way to implement the Principles of Green Chemistry.

The collaboration will provide GMP manufacturing ahead of future clinical studies.

A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.

A new study in Nature Communications explores how to remove the bulk of the soaps that are added to injectables to make hydrophobic drugs more soluble.

Bioprocess operations-from cell line selection to final filtration-can influence the consistency and purity of biologic drug substances.

Shire announces plans to build a flexible biopharmaceutical manufacturing facility in County Meath, Ireland.

A global API marketplace increases the burden of supply chain monitoring for drug companies.

Unsafe material may remain in the US supply chain, according to a March 29th letter to FDA Commissioner Califf

Novo Nordisk broke ground on a facility in Clayton, NC, to manufacture APIs for GLP-1 and insulin medicines.