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Mastering Antibody-Drug Conjugates

In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.

Mechanical Robustness of 2R Glass Vials Across Fill/Finish Operations: Implications for Biopharma Manufacturing

While allowing for high throughput and efficiency, the bulk fill/finish process exerts extreme stress on glass containers, resulting in cosmetic defects and breakage.

The Manufacturing Journey of CAR-T Cellular Therapy—An Overview

Allogeneic CAR-T therapies deliver scalable, off-the-shelf cancer therapy, while autologous CAR-T therapies provide patient-specific but time-intensive treatment.

Supply Chain Execution in Radiopharma: The Industry’s Next Critical Challenge

Andrea Zobel and Marco Hogenboom of Cencora World Courier discuss the operational and logistical challenges shaping the radiopharmaceutical sector as therapies move toward broader commercialization. The executives outline how regulatory complexity, short delivery windows, AI-enabled logistics systems, and global coordination requirements are redefining advanced therapy supply chains.

Meeting Secondary Packaging Challenges of Innovative Delivery Systems for Biologics

Rapid market growth in biologics is helping the packaging market expand as well, but the complex nature of biologics and the desire for personalized therapies present unique hurdles to make packaging solutions cost-effective and safe for patients.

Comparative Deterministic Cold Storage Headspace Analysis–Multi-sourced Injectable Container Closure Systems

This study evaluates the best-in-class elastomer compounds, formulations, and coatings, affixed with aluminum seals and press-on caps to Type I borosilicate tubular glass vials conforming to the International Organization for Standardization (ISO 8362) injection containers requirements.

Inside Codexis: Transforming RNA Manufacturing

Britton Jimenez, SVP of Sales and Marketing at Codexis, explains how the ECO Synthesis® Manufacturing Platform overcomes the limitations in scalability and sustainability that currently challenge the RNA therapeutics industry.

Top 10 Cleanroom Problems That Can Be Prevented via Preventative Maintenance

Cleanrooms require strict environmental control to maintain sterility, prevent contamination, and ensure seamless operations. Without a proactive preventative maintenance (PM) program, various issues can arise, leading to costly downtime, contamination risks, and operational inefficiencies. Below are ten common cleanroom problems that can be effectively mitigated through proper PM practices.

New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.

EU’s MIDBA Framework Could Eliminate Repetitive PK Bridging Studies for Auto-Injectors

A new European Union regulatory framework known as MIDBA may streamline auto-injector approvals for biologics by reducing the need for repetitive pharmacokinetic (PK) bridging studies. Charles Theuer discussed how the model-based approach could accelerate drug-device combination development and potentially influence future FDA policy.

Reshaping Outsourced Development and Manufacturing

Outsourced partners can help innovators make better decisions earlier in development, before uncertainty becomes late-stage risk.

Fresenius Kabi Contract Manufacturing Focuses on Your Success

Saleem Farooqui of Fresenius Kabi explains how the company is addressing today’s pharmaceutical manufacturing needs. Watch this video to learn how these capabilities can help bring products to market successfully.

How Automation Is Improving AAV Purification for Gene Therapy Development

Automated density gradient ultracentrifugation boosts the efficiency of AAV purification.

Navigating Biopharma Complexity: Why Long-Term Partnerships Matter

Trust-based CDMO partnerships are becoming essential to accelerate injectable drug development, manage risk, and ensure resilient biopharma supply.

How Modularization and Digital Delivery are Transforming Pharma Manufacturing

Modular and replication strategies are being utilized to meet growing demand for CDMO facilities.

Mechanical Robustness of 2R Glass Vials Across Fill/Finish Operations: Implications for Biopharma Manufacturing

While allowing for high throughput and efficiency, the bulk fill/finish process exerts extreme stress on glass containers, resulting in cosmetic defects and breakage.

Addressing manufacturing at scale for ATMP’s

Addressing manufacturing at scale for ATMP’s. Reducing costs through reducing batch failures and shrinking footprints, and targeting more focused critical quality attributes for potency but also patient efficacy. Reducing regulatory uncertainty in an uncertain environment to increase patient access to life saving cures.

CRISPR Gene-Editing Technology in the Development of Biopharmaceuticals

Novel nucleases with diverse properties represent promising solutions, emphasizing their potential to overcome current limitations in genome editing and therapeutic delivery.

Axial Compression Column Packing at Process-Scale: Resin Compressibility Insights and Considerations

Webinar Date/Time: Tue, Oct 14, 2025 10:00 AM EDT

Subcutaneous Infliximab Shows Promise for Durable, Patient-Centered IBD Care

Celltrion’s Dr. Juby Jacob-Nara discussed how subcutaneous infliximab may improve convenience, adherence, and sustained remission for patients with inflammatory bowel disease, while reducing reliance on infusion centers and supporting broader patient-centered treatment goals.

Securing the Supply Chain through Purchasing Controls

The development, quality, and procurement teams should work together to determine which materials and suppliers are needed, says Jane Zhang, Co-Founder & Co-CEO, ETCH Sourcing, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company.

Guidance on Quality Culture Standards

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.

Helping you navigate the evolving antibody therapeutic landscape

The Evolving Cost-Benefit Landscape of Biosimilar Drug Development

With more than 100 next-generation biologics set to lose patent exclusivity in the next 15 years, there is widespread agreement that developing biosimilars for these therapies will benefit society as a whole.

Developing Next-Gen Cell Lines Using Targeted Integration

Targeted integration enables predictable clonal cell lines, enhancing transgene control and accelerating biopharma cell line development.

Developing Next-Gen Cell Lines Using Targeted Integration

Targeted integration enables predictable clonal cell lines, enhancing transgene control and accelerating biopharma cell line development.

Considerations for Quality Improvement of Cleaning, Disinfection, and Cleaning Validation in Biopharmaceutical Manufacturing, Part II. Biopharmaceutical Non-Sterile Equipment Cleaning

This second part of a two-part article provides a clear understanding of microbiological load reduction during cleaning processes in the non-sterile pharmaceutical manufacturing.

What It Takes to Support Emerging Biopharma Programs Through Rapid Candidate Identification

Success in emerging biopharma depends not only on speed, but also on making confident, data-informed decisions early in development while managing increasing molecular complexity.

The Importance of Innovation in Mission-Critical BioPharma Cold Storage

Precise cold chain management is essential to safeguard biologics, but traditional ULT freezers can’t keep pace with the demands of modern drug development.

Choosing the Right CDMO for Long-Term Stability

Dr. Patrick Meyer, Global Head of Business Development at Rentschler Biopharma, outlines the deciding factors biotechs should consider when selecting a contract development and manufacturing organization (CDMO) partner.