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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.

Specification Equivalence: A Practical Approach to Method and Acceptance Criteria Equivalence

The authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.

Powering Clinical Operations With Knowledge Graphs and LLMs With Merck KGaA, Darmstadt, Germany

Webinar Date/Time: Thu, Mar 13, 2025 11:00 AM EDT

Selecting the Right Drug Delivery Formulations to Enhance Patient-Centric Care

A growing demand for liquid medicines is driven by patient groups' unique needs, improving compliance through flexible and palatable dosing options.

Benefits of Wireless Continuous Monitoring Systems

Best Practices in Host Cell Impurity Analytics – Using Advanced Technologies and Methods to Monitor, Control and Quantify Host Cell Proteins

Webinar Date/Time: Thu, Sep 4, 2025 11:00 AM EDT

Specification Equivalence: A Practical Approach to Method and Acceptance Criteria Equivalence

The authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.

Best Practices for Quantification of Residual Host Cell DNA with Real-time PCR

Improving Vector Yield at Scale: A Fresh Approach to Cell Lysis Quality Assessment

Optimizing the harvest of viral particles is important for the yield and purity of the final product.

Design Quality in Pharmaceutical Design: A Primer for Facility Executives

Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.

Specification Equivalence: A Practical Approach to Method and Acceptance Criteria Equivalence

The authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.

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.

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.

MHC-Associated Peptide Proteomics: Immunogenicity and Vaccine Design

This article looks at how the MAPPs assay works, how it integrates with other immunogenicity assays, and just how it can be flipped to help in vaccine design.

FDA Approves Kedrion's Bolognana Plant for Production of PLGD-1 Therapeutic

With FDA's clearance, Kedrion can manufacture Ryplazim (plasminogen, human-tvmh), the first and only FDA-approved therapy for treating PLGD-1, at its Bolognana, Italy, site.

Comparability in Accelerated or Stressed Stability Studies Using a Quality Range

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.

Risks, Resource Strain, and Trade-Offs in FDA’s CNPV Pilot Program

Industry experts weigh in on the potential impacts of FDA’s CNPV pilot on safety trade-offs, resource strain, and unclear incentives for sponsors.

Mechanistic Hypothesis of Toxicity: Driving Decision Making in Preclinical Translation

Mechanistic toxicity hypothesis is essential in guiding decision-making and predicting toxicities during the preclinical stages of drug development. The authors highlight the growing importance of integrating advanced technologies like mass spectrometry imaging into toxicology to enhance preclinical translation, foster innovation in therapeutic development, and ultimately improve drug safety and efficacy.

DuPont Innovative Solutions: Addressing the Challenges of Biopharmaceutical Manufacturing

Webinar Date/Time: Wednesday, April 2, 2025 11:00 AM EST

Extractable and Leachable Challenges in Lyophilized Drug Products

The authors examine the risks of extractables and leachables and present solutions that emphasize the importance of a strategic multi-prong approach.

Ensuring Biologic Stability with Tailored and Cutting-Edge Lyophilization Solutions

Explore how tailored lyophilization solutions, integrated with quality-by- design principles and advanced modeling, help optimize stability, reduce costs, and enhance global accessibility for biopharmaceuticals.

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.

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.

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.

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.

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.

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.