Authors

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.

The Promise of Microgravity for R&D and Manufacturing

As access to low Earth orbit expands, space-based research is opening possibilities in drug discovery, formulation, and manufacturing. In Part 1, the authors look at how microgravity changes biology and chemistry in ways that can’t be reproduced on Earth and where it fits from target discovery to life cycle management.

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.

Drug Digest: Expedited Regulatory Pathways for Biologics

Experts Harpreet Singh and Steven Quay discuss FDA expedited regulatory pathways for biologics, including Fast Track, Breakthrough Therapy, RMAT, Real-Time Oncology Review, and the National Priority Voucher Pilot Program, and explain how these mechanisms can accelerate development without lowering evidentiary standards.

The Promise of Microgravity for R&D and Manufacturing

As access to low Earth orbit expands, space-based research is opening possibilities in drug discovery, formulation, and manufacturing. In Part 1, the authors look at how microgravity changes biology and chemistry in ways that can’t be reproduced on Earth and where it fits from target discovery to life cycle management.

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.

IPEC’s EIP: A Standardized Communication Platform for Sharing Excipient Information as an Alternative to Questionnaires

IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.

Q&A with Dr. Athenesia Faggins: Practical Challenges in Raw Material Management for Advanced Therapies

Athenecia Faggins of Minaris Advanced Therapies discusses raw material qualification, supplier management, testing, and risk control for advanced therapy manufacturing.

Biogen’s Salanersen Shows Potential to Address Unmet Needs in Spinal Muscular Atrophy

In an interview with BioPharm International, Stephanie Fradette, head of Biogen’s Rare Neurology Development Unit, discussed FDA Breakthrough Therapy designation for salanersen and early Phase 1b data evaluating the therapy in individuals with spinal muscular atrophy who had suboptimal responses following gene therapy.

IPEC’s EIP: A Standardized Communication Platform for Sharing Excipient Information as an Alternative to Questionnaires

IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.

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.

Solving QC Bottlenecks and Enabling Scalable, Fully Automated QC

Cell therapy QC bottlenecks stem from fragmented systems, for which scalable, automated ecosystems require systems-level redesign, digital integration, and mindset shift.

FDA’s ARC Program Highlights Opportunities and Limits of Bayesian Methods in Rare Disease Trials

Dr. Paz Vellanki discusses Bayesian methods, challenges in developing rare disease endpoints, and why sponsors should engage FDA early in clinical development.

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.

Integra Therapeutics Targets Next-Generation CAR T Development with FiCAT Gene Writing Platform

Integra Therapeutics is advancing its FICAT gene writing platform to enable more sophisticated CAR T-cell engineering, combining CRISPR precision with high-capacity DNA integration for next-generation cancer therapies.

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.

Human-Based Preclinical Models May Improve Toxicity Prediction in Oncology Development

At BIO International Convention 2026, Mohit Trikha, PhD, CEO of Kiva Bioscience, discussed why emerging human-based preclinical models may have their greatest impact in predicting drug toxicity and tolerability rather than replacing animal testing outright.

PDA Week 2026 Plans Unveiled

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.

Reducing Timelines and Eliminating the White Space in Complex Biologic & Bioconjugate Development

Campbell Bunce, CSO, Abzena, explains their integrated drug development model that combines front-end R&D with process development and manufacturing under one roof.

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.

De-risk Biologic Development: Engineering Flexibility from Early Development to Launch

Jonathan Haigh, Head of UK Sites, FUJIFILM Biotechnologies, explores how advanced technologies are being used to reduce risk and strengthen global supply chains for biologics.

Adalvo Acquires Enzene’s Romiplostim Biosimilar Program for ITP

Adalvo’s purchase of Enzene’s Nplate biosimilar program extends it into biologics and moves Enzene toward a CDMO-only model.

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.