Newsletter | April 5, 2024

04.05.24 -- Process Development With "The End In Mind" For Startups

SPONSOR

Webinar: Instant Implementation Of RAMAN-Based Monitoring And Control For Key Upstream Bioprocessing Parameters

Join us as we discuss the benefits of MAVERICK, a novel Raman spectroscopy-based PAT solution that can be easily deployed without bioprocess-specific model building. Learn how this platform effortlessly operates as a pH-meter, providing real-time measurements of key process parameters. Discover how it provides access to high-quality, full-spectrum Raman data, facilitating comprehensive bioprocess development. Click here to learn more.

FOCUS ON PROCESS ENGINEERING

Process Development With “The End In Mind” For Startups

We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.

Process Considerations For Closed Connected Processing

By giving examples for the implementation of closed, connected processing in large-scale manufacturing, this paper will help you explore and assess options that work for your objectives.

Increase Yield and Scalability Of Plasmid And mRNA Manufacturing

Review a successful optimization process that increases the yield of plasmids, the precursors for mRNA synthesis, and achieves a scalable, efficient process for high-quality mRNA production.

Optimizing Scale-Up Of AAV Gene Therapy In Upstream Processing

Explore more detail on how to achieve a 2000L scale-up and studies that have been optimized through process characterization and experimental approaches to better understand key process steps.

Process Optimization For mAb Commercial Manufacturing

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

Building Better BioTherapeutics Using ML And Synthetic Biology

Learn about high throughput biologic automation and GMP master cell banking services as well as variable selection services that search the SQL space to find promoters.

Soluble Versus Insoluble Expression In Microbial Fermentation

Expression of inclusion bodies has historically suffered a bad reputation in the industry. So, how do these two routes, soluble and insoluble, compare in terms of their advantages and challenges?

Organ-Chips And Animal Models: Sensitivity Explained

Learn about the significance of sensitivity in drug development and how researchers can improve their pipelines by employing more sensitive models.

Development And Scale-Up Of Insoluble, Microbially Expressed Biologics

Inclusion bodies, which are typically undesirable, are now gaining attention for their potential to produce a range of difficult-to-express proteins in E. coli systems.

Current And Emerging Technologies To Optimize mRNA Manufacturing

Explore the benefits of using mRNA for vaccines and therapeutics, and learn how to address technical, intellectual property, and cost considerations when considering commercial production.

Addressing High Aggregate Challenges In Engineered mAbs

Explore a resin-based method showing promise for effectively reducing high aggregate levels in mAbs, delivering high monomer yields with low aggregate impurity levels, and enhancing mAb purification.

PROCESS ENGINEERING SOLUTIONS

Process Development - ElevateBio

All-Inclusive Modular Liposome Extrusion Systems - Helix Biotech

Leveraging Proprietary CDO Platforms - Samsung Biologics

Phase-Appropriate, Tailored Process Development Support - Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises

Developability Assessment - JOINN Biologics

FOCUS ON FACILITIES DESIGN

Huh? Where Did That Environmental Monitoring Hit Come From?

After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.

Utilize Modular Cleanrooms To Reduce Your Risk Of A Form 483 Violation

Maintaining a cleanroom facility that remains safe for your workers — and where the therapeutics they produce remain safe for patients — can ease your compliance concerns.

ISO/DTR 14644 -21 Cleanrooms And Associated Controlled Environments

Here, we review the Technical Report (TR) outlining how particle counters are used to classify and monitor cleanroom performance, ensuring it meets required standards under normal operating conditions.

Big Pharma Rethinking Resource Recovery Strategies

Here, we provide systematic methods to increase return on investment. Discover the seven primary investment recovery channels.

The Chemistry Of Aqueous Cleaning

In this chapter of The Aqueous Cleaning Handbook, we explore the key definitions of aqueous cleaner ingredients, the types of aqueous cleaners, and the application of isoelectric points to cleaning.

Increasing mRNA Capabilities And Capacity

The growing mRNA vaccine market — projected to reach $127.3 billion by 2027 — is fueling high demand for mRNA, which has resulted in a critical need to address mRNA manufacturing bottlenecks.

FACILITIES DESIGN SOLUTIONS

Pharmaceutical Cleanroom Pre-Engineering And Pre-Construction Services - AES Clean Technology, Inc.

Addressing Rapid Biomanufacturing Capacity Needs - Cytiva

Facility Overview Video: Scorpius BioManufacturing - Scorpius BioManufacturing

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