Newsletter | September 6, 2024

09.06.24 -- Are You Taking The HPCs In Your ADCs Seriously?

FOCUS ON FACILITIES DESIGN

Are You Taking The HPCs In Your ADCs Seriously?

The wave of ADC (antibody-drug conjugate) development and manufacturing activity we’re currently witnessing, and importantly, the HPC (high-potency compounds) comprising the payloads in these therapies, demand thorough assessment of development and manufacturing facility design.

Connection Technologies Enable Modular Single-Use Systems

Explore the benefits, challenges, and solutions presented by modular single-use systems.

Single-Use vs. Stainless Steel Debate In Biopharmaceutical Manufacturing

Investigate the advantages and disadvantages of single-use technologies and stainless steel systems with a focus on performance, adaptability, and economics.

Avoiding IT Outages With Continuous Cleanroom Monitoring Technology

Examine how one environmental monitoring system provided seamless and continuous cleanroom monitoring and control during the major global IT outages due to the CrowdStrike incident.

Reducing Risks In Your SIP Validation Cycles

Utilizing tape for positioning during Sterilize in Place (SIP) validation can introduce numerous issues. Explore the top eight reasons why tape should be avoided during SIP validation cycles.

FACILITIES DESIGN SOLUTIONS

Addressing Rapid Biomanufacturing Capacity Needs - Cytiva

Biopharmaceutical Cleaning Validation - Alconox Inc.

FOCUS ON PROCESS ENGINEERING

Should You Be Using Unique Container Identification?

Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.

Antibody Coverage Analysis Of E. coli HCPs In The BL21(DE3) Strain

Review a study conducted to determine the suitability and similarity of Cygnus E. coli HCP ELISA Kits to quantify BL21(DE3) Host Cell Proteins (HCPs).

Considerations In Depth Filter Scale-Up

Explore study findings aiming to assist process development scientists and engineers in understanding the structure of depth filter capsules, identifying key parameters for development, and more.

Process Optimization For mAb Commercial Manufacturing

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

The Aqueous Cleaning Handbook

This handbook is intended to assist laboratory and manufacturing plant scientists and engineers in accurately selecting and maximizing the performance of aqueous cleaners and systems.

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.

Building A Broad Oncology Portfolio With SOTIO CEO Dr. Radek Špíšek

Establishing an organization that can manage a diverse development pipeline for oncology therapies requires an equally diverse wealth of expertise.

Welcoming The "Era Of ADCs"

Dr. Loretta Itri sat down to explore the promise of TRODELVY®️ and other antibody-drug conjugates as transformative treatments for a range of malignancies and intractable diseases.

Distinguish And Quantify Particles In Adenoviral (AdV) vectors Capsids

Explore the application of macro mass photometry in analyzing AdV vectors, distinguishing between empty and full viral capsids, and accurately measuring the proportion of full capsids present.

Combining Digital Platforms And QbD Principles

How can data and digitalization further improve pharmaceutical development and the continuous, quick, and efficient delivery of products?

Universal AAV Enhancer For Better Titers, Quality, And Lower Costs

AAV therapies require high quality and high titers of viral genomes per dosage, prompting the need for a more efficient AAV manufacturing method to reduce overall costs.

Reaching BLA Success: Fast-Track Approach To Process Characterization

Discover how knowledge of microbial processes and process characterization understanding can be used to design targeted BLA programs while managing risks.

Engaging Early In Process Development To Bring mRNA Sequences To Life

Examine why template sequence characteristics are relevant for cGMP manufacturing of high-quality mRNA and consider insights on how to develop a scalable, robust, and economically viable process.

Big Pharma Rethinking Resource Recovery Strategies

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

Developability Assessment Of Three Therapeutic Antibodies

This poster reviews studies for three monoclonal antibody drug candidates utilizing a panel of small scale, fast, and predictive tests used to evaluate therapeutic antibodies’ developability.

PROCESS ENGINEERING SOLUTIONS

Superior Transfection Solution Scalability And Efficiency - MaxCyte, Inc.

Streamlining Your AAV Characterization - Refeyn

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