Facility Design and Engineering

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.

Recent investments show expansion activity in cell culture facilities.

The biotechnology company has filed for FDA approval of a new plasma manufacturing facility in Covington, GA, to support its immunology franchise.

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

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.

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

The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.

The company will expand two of its Ohio facilities, investing approximately $145 million to support manufacturing and warehouse operations.

The company has opened a new California facility that, combined with its existing site in Foster City, CA, will quadruple its laboratory footprint for gene therapy products.

In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.

A new facility type integrates next-generation mobile cleanroom systems.

The use of approved platform technologies can reduce the time and cost required to generate new vaccines.

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 API manufacturer has announced that it has completed the expansion of large-scale manufacturing capabilities at its Charles City, Iowa site.

The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.

The company is investing EUR 170 million (US$201 million) to expand its vaccine manufacturing site in France for its newest influenza vaccine.

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.

Eurofins Scientific has opened a £4-million (US$5-million) pharmaceutical chemistry and microbiology facility in Livingston, Scotland, to support the company’s product and water testing businesses in the UK.

Fresenius Kabi broke ground on a previously announced $250 million expansion of its Melrose Park, IL, manufacturing facility.

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

The International Society for Pharmaceutical Engineering announced the release of ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition).

FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.

Roquette, a biopharmaceutical company specializing in plant-based excipients, announced the opening of a new R&D and customer technical service facility in Singapore in fall 2017.

GlaxoSmithKline (GSK) opened a new vaccine manufacturing facility in Montrose, Scotland. The £44 million (US$57 million) facility will be used to manufacture aluminum salts, which are used for vaccine production.

The acquisition adds sterile manufacturing capability to the CDMO’s services, which include API formulation and manufacturing.