Manufacturing

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

TCR² Therapeutics will add a second clean room to their manufacturing operations.

GenScript’s new gene synthesis center in Piscataway, NJ, is highly automated to accelerate production time and increase supply chain resiliency for biopharma and synthetic biology.

Gentronix has expanded it lab facilities and increased capacity for genetic, ocular, and skin toxicology testing.

Thermo Fisher Scientific showcases its new mass spectrometry and chromatography solutions at the ASMS Conference on Oct. 31–Nov. 4, 2021.

Lonza is expanding its exosomes development and manufacturing capabilities with the acquisition of a service unit from Exosomics and a manufacturing facility from Codiak BioSciences.

Janssen Sciences Ireland was honored for its project execution of a large-scale expansion of biologics drug substance fed-batch capacity.

ADC development is on a positive trajectory from a deeper understanding of therapeutic mechanisms and technological advances.

The adoption of perfusion cell culture continues to advance with the help of PAT tools.

The need for improved analytics grows.

Disposable equipment components find use in small-volume aseptic biopharmaceutical manufacturing.

A coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.

The research collaboration between Sartorius and Matica Biotechnology will aim to optimize PAT technologies, automation software, and single-use platforms for large-scale viral vector production.

Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia.

The $691 million deal will see Vertex use Mammoth’s systems to discover and develop in-vivo gene-editing therapies.

Global CDMO, ten23 health, has acquired filling technology and drug product manufacturing expert, swissfillon, enhancing its integrated offering.

SGS’s new Antwerp, Belgium, clinical research site will house both clinical trial patients and good manufacturing practice drug manufacturing, and its Glasgow, UK, biosafety testing site now has increased testing capacity.

A new GMP facility in Raleigh, NC, and a starting materials facility in Paris, France, give Cellectis end-to-end, in-house manufacturing capacity for its UCART product candidates.

EMA's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.

ANGUS’ planned expansion will double its tromethamine buffer production capacity.

Evonik’s LIPEX Flow extruder is a new version of its high-pressure equipment for manufacturing liposomal drug products.

In this collaboration, Takeda will utilize Poseida's biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of gene therapies.

MilliporeSigma announced the opening of its second Carlsbad, California-based facility, which doubles production capacity to support commercial and industrial manufacturing of viral vectors.

BioPharm International checked in with AAPS, IPEC-Americas, and PDA to get an update on how the organizations are navigating the pandemic and planning for the future.

For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.

Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.

Aceto will acquire A&C Bio Buffer, including the company’s custom buffer and chemical blend portfolio.

The collaboration between Intellia and SparingVision will work to develop genomic medicines for ocular diseases.