Manufacturing

Recent technological advancements may have put cleanroom monitoring into a state of flux.

Production of viral vectors requires a holistic view of the product, including its manufacturing process and its ultimate end use.

Experts outline the benefits of single-use consumables relative to traditional approaches.

External expertise is beneficial in helping companies select the right tools at the right stages of development to ensure success.

Standardized risk assessment and analysis protocols facilitate the comparison of processing equipment components.

BFS technology can help maintain sterility during the biologics manufacturing process.

Various advances in contamination control are being utilized to reduce the chance pollutants contaminate a drug product.

Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.

A blended approach to newly revised regulatory guidance to inform environmental monitoring programmes is essential.

Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.

FDA backs joint reviews, common research policies, and modern production methods around the world.

ROSS Ribbon Blenders are a customizable solution designed to minimize risk and maximize productivity.

The new inorganic pyrophosphate from Canvax is intended for use in RNA IVT reactions.

L.B. Bohle’s QbCon 1 is intended to meet all quality requirements for long granulation processing time.

Codex DNA’s BioXp 9600 system is designed for the automated synthesis of synthetic biology workflows.

Forge Biologics will offer three grades of plasmid manufacturing services at its Columbus, Ohio, location.

PerkinElmer has unveiled a cell analysis solution to streamline cell and gene therapy research and manufacturing.

The dedicated solid-state research and development suite is designed to promote discovery of novel polymorph, salt, and cocrystal forms.

Lonza has expanded its HPAPI multipurpose suite for payload-linker manufacturing.

Boehringer Ingelheim will use Virtuosi to train employees at three aseptic sites across its network.

Choosing low-adsorption glass vials helps ensure detection accuracy.

Experts from Umoja Biopharma dive into cell therapy development in this episode of the Drug Solutions Podcast, including the greatest advancements in cell therapy to date, areas for improvement, the biggest trends in cell therapy development, and retention as a pain point.

Civica is expanding in the greater Richmond-Petersburg region and investing $27.8 million in a new testing facility.

Automation enables intensification of downstream processes.

Rapidly growing industry must overcome supply chain constraints.

MilliporeSigma’s €130 million (USD$132 million) investment is designed to increase manufacturing capacity of single-use assemblies.

Charles River Laboratories and Cure AP-4 will collaborate on gene therapy manufacturing for AP-4 hereditary spastic paraplegia.

A new survey has demonstrated that remote audits, brought to the fore thanks to COVID-19, are not necessarily a preferred option for clients.

Hovione has expanded its drug product offering with a new manufacturing line dedicated to continuous tableting.

Biopharmaceutical manufacturers must consider a surprisingly wide range of factors when deciding where to turn for assistance with cell line development.