Facility Design and Engineering

Amgen plans to invest approximately $300 million in a new biomanufacturing plant in the United States.

Layout and supply details must be considered when implementing a fully disposable biopharmaceutical manufacturing process.

Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.

BioPharm International asked Andrew Bulpin, head of Process Solutions at MilliporeSigma, about the end-of-life options for disposable components of biopharmaceutical single-use systems.

The contract development and manufacturing organization has invested £30-million (US$42 million) at its Dundalk, Ireland site to offer expanded clinical trial services.

The company relocated its headquarters to Riverview, Florida.

GE Healthcare will equip Cellular Biomedicine Group's cell therapy manufacturing facility in Shanghai, China, with its FlexFactory single-use platform, designed to speed up cell therapy manufacturing timelines.

Sartorius Stedim Biotech will equip Abzena’s contract development and manufacturing facilities in Bristol, PA, and San Diego, CA, with single-use equipment and scale-up technologies.

Athenex is moving forward with the construction of a new 320,000-square-foot pharmaceutical manufacturing facility in Dunkirk, NY, and has hired the German engineering firm, M+W, to design and construct the facility.

AptarGroup’s Landfill Free Certification program addresses the issue of waste production from pharmaceutical manufacturing processes by prompting its facilities to reduce and reuse operation waste.

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.