Newsletter | October 29, 2024

10.29.24 -- Suppliers Pushing Novel Analytical Methods Testing Forward

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Developers often aim to cut expenses during development. Discover the long-term outcomes of cost-effective measures like using RUO leukopaks compared to investing in high-quality GMP-grade vectors.

FOCUS ON OUTSOURCING

Suppliers Pushing Novel Analytical Methods Testing Forward

The urgency to develop novel therapeutics must be balanced by rigorous safety testing, but cell and gene therapy testing protocols, of which there are many, have to date been neither standard nor quick. What role are outsourced testing service providers playing to change that paradigm?

A Scalable And Robust Lentiviral Platform For GMP Manufacturing

Review a well-established platform process for lentiviral vector (LV) production based on transient transfection of serum-free cells grown in suspension.

Accelerating Your Gene Therapy: Not All Platforms Are Created Equal

Standardized methods, materials, and analytics are critical for overcoming hurdles in the gene therapy space. Explore how a platform approach to fast-track AAVs can enhance quality and efficiency.

Considerations In CMC For Antibody-Drug Conjugates

The complex nature of ADCs necessitates meticulous attention to CMC. Gain valuable insights for navigating CMC development, ensuring the delivery of safe and efficacious biopharmaceutical products.

Transforming Safety: A Customer Centric Model For Patients And Employees

Explore unique infrastructure around safety operations and quality, with a focus on a new product introduction process with respect to risk assessment.

8 Key Partner Quality Attributes Your CDMO Must Have

CDMOs help reduce the complexity and costs of drug development and manufacturing, making the right CDMO partner essential for many biopharma companies.

Manufacturing Process Transfer: Challenges And Keys To Success

A successful technology transfer sets the stage for GMP production and opens the door to process performance qualification campaigns and licensure.

Advancements In Microbial Manufacturing Of Biopharmaceuticals

Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.

The Potential Of Intensified Scalable Adherent Cell Culture

Intensified adherent cell culture offers a promising solution to the limitations of traditional suspension culture, with the potential to improve efficiency, reduce costs, and accelerate development.

Overcoming Challenges In Combination Product Manufacturing

Blending pharmaceuticals and medical devices into a single product offers immense potential for patient care, but manufacturing these combination products presents unique hurdles.

Navigating The Analytical Complexity Of Oligonucleotide Therapeutics

From identity and purity testing using chromatography and electrophoresis to PCR and microbial studies, explore advanced analytical solutions tailored for siRNA, miRNA, pDNA, and mRNA products.

Tips For Successfully Scaling From R&D To Manufacturing

By partnering with a trusted company that offers expertise in navigating the challenges of scale up, drug developers can have confidence in their ability to successfully bring their products to market.

Accelerate And De-Risk Bioconjugate Drug Development

With a growing interest in developing new and improved bioconjugate drugs, explore an “innovation through collaboration” approach that can facilitate access to next-generation conjugation technologies.

Precision Volume Accounting In Fed-Batch Cultures

Are you searching for a better way to calculate growth rate? Explore a new approach that performs the rate calculations using a simple method to correct for volume changes.

How Client Input Shaped A Production Facility Expansion

In addition to streamlining processes and implementing new technologies, new facility design provides tremendous opportunity to positively impact client timelines, costs, and options for flexibility.

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Webinar: Introducing Two New Highly Effective ADC Payloads For Cancer Therapeutics

Despite increasing interest in ADC drug development, access to safe and effective therapeutic agents (also known as payloads) and linkers is limited. Join us November 6th to learn more about Samsung Biologics’ two novel ADC payloads that demonstrate best-in-class efficacy and safety profiles upon extensive characterizations in vitro and in vivo.

OUTSOURCING SOLUTIONS

Adenovirus Vector Lot Release Package - WuXi Advanced Therapies

A CGT CDMO With Devotion - Theragent

Bionanoparticle Technology - Nanoform

Premier European Product Launch And Packaging Solution - Catalent

Combining Scientific Knowledge And Advanced Technology - Mabion

Live Biotherapeutics And Next Gen Manufacturing - Sacco System

Entegris Life Sciences Technology Center And Partnership Services - Entegris, Inc.

Accelerating Cold Chain Expansion - Jubilant HollisterStier

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