Newsletter | June 14, 2024

06.14.24 -- Bioprocessing Technology: You Are The Standard


Webinar: Embarking on a Successful Cleanroom Project: Conception to Delivery

Join AES on June 26th! Successful cleanroom projects rely on accurate foresight for regulatory compliance, defining process operations and facility relations. Conceptual design, tailored to client needs, sets the project on course. Our turnkey approach starts at conception, assesses processes, and ensures optimal functionality. Integrated construction uses quality materials for durable, compliant spaces, meeting cGMPs and regulatory expectations. Click here to learn more.


Bioprocessing Technology: You Are The Standard

Single-use bioprocessing equipment engineer and expert Paul Priebe has some advice for you. Next time you catch yourself questioning an equipment standard (or the lack thereof), take a good look in the mirror. 

Selecting The Right Single-Use Materials In Biopharmaceutical Manufacturing

Manufacturing operations are getting a boost thanks to single-use technologies, but how do biopharmaceutical manufacturers choose the right materials for constructing their single-use solutions?

Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology

Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.

Cleaning Proteins, RNA, And DNA From Laboratory Equipment

Learn about three of the best methods for cleaning proteins, RNA, and DNA from laboratory equipment.

Environmental Risk Assessment: PQ Systems And Tools

Hear from a Senior GMP Scientist about environmental monitoring and contamination control for aseptic pharmaceutical manufacturers, along with the impact of effective cleanroom monitoring.

Manual vs. Automated Labware Washing

Compare manually washed labware and labware cleaned in automatic washing systems, to see how the challenges of manual washing can impact your labs efficacy and repeatability.


Plant 5 - Dream Plant: Within Your Reach. Built For Your Success. - Samsung Biologics

Cleaning And Disinfecting For Viruses And Other Pathogens - Alconox Inc.


A ballooning clinical-stage ADC development community is putting stress on both manufacturing capacity and antibody engineering and conjugation talent. What does this burgeon mean for ADC manufacturing, process development, and, ultimately, clinical progress? Join Bioprocess Online Live on July 9th as we navigate the complexity of the ADC manufacturing environment. From linkers to payloads to conjugation, we’ll cover the lay of the land for developers. Registration is free thanks to the support of Cytiva.


Defining And Overcoming Batch Release Deviations

Agencies lack a specific definition for deviations, so it’s up to each company to clearly define what they, and then build systems to prevent and react to them.

Implementing A Risk-Based Approach To Calibration

Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.

Best Practices To Adapt And Improve Quality Control Programs For CGTs

Cell and gene therapies require adaptive, advanced assays for characterization and safety assessments; in many instances, the assays historically used for biologics must diversify to accommodate them.

PEG In LNP Formulations: Addressing Challenges And Seeking Solutions

Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks. Explore those concerns, here.

Formulating Better ASDs And mAbs: Advances In Applied Nanotechnology

Learn about new data on nanotechnology formulations for multiple dose forms and routes of delivery, including oral, long-acting injectables, inhalation, and ophthalmic.

Assessing Reliability, Confidence, And Batch Variation In PPQ Runs

Examine the procedures and benefits of two statistical methodologies and how new technologies are requiring a risk-based approach to calculate the necessary number of PPQ runs.

Evaluating CAR T-Cell Therapy Recruitment And Efficacy

Learn about Organ-on-a-Chip technology and how it can be employed to assess the efficacy of CAR T-cell therapies against solid tumors.

Comparing Mass Photometry And CDMS For AAV analysis

Review the results of a study comparing mass photometry and CDMS techniques for their ability to distinguish AAV loading distributions and evaluate adeno-associated virus (AAV) capsid content.

Optimization-By-Design - A Critical Factor In Viral Vector Scale Up

Learn how leveraging the expertise and capabilities of an experienced partner is a key factor in optimizing AAV processes using Design of Experiment, thereby reducing variability and risk.

Optimization Of Nuclease Digestion Unit Operation In A LVV Process

Discover the statistical analysis results based on several DoE studies for the reduction of hcDNA and pDNA levels in a lentiviral vector (LVV) platform process.

Potency Assays 101: How To Develop A CMC Relative Potency Assay

This eBook dissects the potency assay development process into its key steps, offering a clearer understanding of the journey.

Optimized Performance Model For Yield And Quality Of The mRNA Product

Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment approach.

Putting The “Process” Into Process Characterization

Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Explore a platform approach to Process Characterization that's been proven effective.

Establishing A Stage-Gate Approach To Biomanufacturing

Biotech leaders highlight how to perform critical activities leveraging process and analytical development resources from early-stage clinical to commercialization.

How To Bring (Any) mRNA To Life: Simplifying Nucleic Acid Encapsulation

New technologies for the encapsulation of nucleic acids, such as FDmiX, can potentially overcome limitations of currently available standard mixing technologies.

Innovative Analytical Strategies To Address Development Challenges

Discover analytical strategies designed to address challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs, and diverse post-translational modifications.

The History Of Microcalorimetry

Here, we review the beginnings of calorimetry and microcalorimetry along with their modern history, applications, and use in biologics drug development.


How To Choose A Capping Method In MRNA Production - Cytiva

Culture Module That Sustains The Life Of Cells - Emulate

Analytical Assay Development & Qualification - JOINN Biologics

Optimize Antibody Developability Using Prometheus - NanoTemper Technologies, Inc.

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