Manufacturing

Successful scale-up and BLA filings for products manufactured by microbial biomanufacturing require strategic planning.

This article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.

Manufacturers are taking the first steps toward process intensification.

DuPont’s new manufacturing site will expand its biopharmaceutical tubing manufacturing capabilities.

WuXi STA is opening a new large-scale oligonucleotide and peptide manufacturing facility.

Guest contributor Frederic Kahn discusses the state of the Indian pharmaceutical manufacturing industry.

TFF Pharmaceuticals is expanding its R&D operations with a new facility in Austin, Texas.

Cytiva has acquired a new chromatography resins manufacturing site in the United States as part of its $1.5 billion capacity expansion investment.

Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.

Wacker is investing more than €100 million (US$100.5 million) to expand its Halle, Germany, site with an mRNA competence center.

Croda has entered into an agreement with the US government to support the expansion of its lipid systems capability.

VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.

Automation and digitalization work together in the digital plant.

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.

Finding specific solutions to overcome uncertainty has led to the evolution of a new clinical trial research environment.

Industry adoption of plant-made biologics remains slow, but plant-based technology gains an advantage by mainstream exposure.

Specialty polymers demonstrate the advantages of single-use consumables in biopharmaceutical manufacturing.

Improved real-time visibility during all segments of handling, transportation, and delivery is keeping costs low and reliability high while helping time- and temperature-sensitive biopharmaceuticals to go the distance without incident.

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.

Getinge’s new DPTE-EXO with Sleeveless DPTE-BetaBag is an alpha port with an external opening and an integrated funnel for automated aseptic transfer.

Inceptor Bio and the University of Minnesota aim to build a novel iPSC platform to accelerate cell therapy drug development.

MilliporeSigma and Lotte Group will collaborate on facility design and workforce training for a new biologics business unit in the US.

Under the collaboration, Avantor and GeminiBio will offer custom cGMP solutions to enhance process efficiency and accelerate speed-to-market of novel emerging therapy modalities.

MilliporeSigma’s new BioContinuum Seed Train Platform offering enables a fully closed bioprocessing environment for both fed-batch and perfusion N-production.

ImmunoGen has formed a research collaboration with Oxford BioTherapeutics to develop novel antibody-drug conjugates for cancers with high unmet needs.

The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.

Batavia Biosciences is expanding its headquarters and R&D capabilities in its Netherlands facility.

SCHOTT is planning to triple its ready-to-use vial production capacity in the United States to meet increasing demand for storing injectable drugs.

Merck has entered into a collaboration with Agilent Technologies with the aim of filling the industry gap in PAT for downstream processing.

Exothera, LogicBioTherapeutics, and Polyplus-transfection, are collaborating on the development of a scalable AAV manufacturing platform.