Authors

Best Practices for Secure Disposal of Controlled Substance Pharmaceuticals

Pharma manufacturers must securely destroy expired or off-spec drugs to meet DEA standards, avoid compliance risks, and protect public safety.

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.

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.

A-TEEM: A Novel, Powerful Tool for Evaluating and Monitoring Cell Culture Media

Fluorescence spectroscopy with A-TEEM offers rapid, precise monitoring of cell culture media variability for improved biopharmaceutical quality control.

Building Robust Biomanufacturing Networks for the Next Wave of Therapies

Biomanufacturing is shifting toward more resilient and digitized networks for enhanced supply security amid global and supply-chain volatility.

Navigating the Next Wave of Biopharma Manufacturing Innovation

The articles in this issue capture a sector balancing innovation with practicality as it prepares for the next generation of medicines.

Optimizing Downstream Processes for Biotherapeutic Development with Prepacked Chromatography Columns

As development of novel drugs accelerates, enhanced downstream production processes maintain product efficacy, safety, and quality.

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.

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.

A Step Closer to Closure in Bioprocessing

As biopharma anticipates the “Facility of the Future,” a definition of what closed processing is, and quantification of its value, can be helpful information.

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.

Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

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.

Inside Codexis: Redefining Pharma Biocatalysis

Mandy Vink, VP of Business Development at Codexis, explains how the company leverages over 20 years of expertise in small molecule APIs to advance biocatalysis across pharma.

Outsourcing Hits Record Levels for All Bioprocess Platforms

Outsourcing is booming across all platforms, from fill/finish to cell therapies, as companies pursue efficiency, scale, and strategic flexibility.

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.

HHS Releases New Guidance on Lowering Prescription Drug Prices Through DTC Programs

The guidance provides clarity to drug manufacturers on offering lower drug prices directly to patients, including patients on Medicare and Medicaid.

Single-Use Technology: Transforming Biomanufacturing Today and Tomorrow

Advanced technology platforms optimize the efficiencies and sustainability of single-use bioreactors, setting the scene for the next evolutionary step in biomanufacturing.

Developing Next-Gen Cell Lines Using Targeted Integration

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

Digital Transformation in Pharmaceutical Manufacturing

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.

Formulation Strategies, Tech Advances, Challenges, and Considerations in Novel Drug Delivery

The transformative impact of complex biopharmaceuticals hinges on integrating advanced delivery systems, often accelerated by AI modeling, with robust manufacturing practices and regulatory alignment to ensure stability, safety, and effective patient access.

Developing Next-Gen Cell Lines Using Targeted Integration

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

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

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.

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.

Gene Therapy Unlocked: Overcome Challenges and Accelerate the Path to Patients

A long-term, trust-based CDMO partnership can support cell and gene therapy developers from early process development through GMP manufacturing and commercial supply.

A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.