07.03.25 -- How APBio Builds Multispecific Analytical Target Profiles

Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

Understanding top safety concerns, from combustible material handling and chemical exposure to HPAPIs, is the first step toward preventing accidents in biopharmaceutical manufacturing environments.

The revised EU GMP Annex 1 mandates a comprehensive Contamination Control Strategy, continuous environmental monitoring, and species-level contaminant identification to ensure compliance.

Discover how Computer Software Assurance updates the FDA's Computer System Validation (CSV) framework to promise streamlined validation and cost reduction despite industry uncertainty.

In aseptic manufacturing, laser induced fluorescence shows great potential to replace growth-based methods in certain manufacturing paradigms — highly automated, near-continuous processes.

Moving beyond last-minute checklists, true Operational Readiness is about intentionally building success into your facility’s DNA. Discover the foundational elements that enable a smoother and safer startup.

Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.

Explore a novel dPCR workflow for tracking CAR-T and leukemia cell biodistribution in rodents that enhances precision, sensitivity, and reliability in preclinical assessments of investigational cell therapies.

While it’s good to track the known CQAs, this industry needs to do a better job of diminishing the impact of “unknown” outputs i.e., through stringent process control over “knowns” via the process. Through this control, certain downstream attributes would be less inclined to wreak havoc.

Review the regulatory expectations for pharmaceutical QC release testing and which additional characterization analytics are anticipated to be required to characterize the mRNA-LNP product.

Ensure product quality and patient safety by examining the FDA's draft guideline on Computer Software Assurance that emphasizes a risk-based approach to streamline software validation.

Learn essential conceptual design principles for transforming alternative spaces into efficient, regulatory-aligned cleanroom environments for your critical processes.

Patient-derived organoids are revolutionizing drug discovery by mimicking tumors and predicting therapeutic efficacy. Discover a scalable bioprocess that enhances reproducibility and cost-effectiveness to pave the way for broader adoption.

Discover a customizable checklist that helps teams evaluate QMS software and focuses on essential features to align with your organization’s unique goals and compliance needs.

mAbs are a type of biological medicine that is used to treat a variety of diseases. The development of biosimilar mAbs is a complex process that requires careful analysis of the product's quality attributes.

Quality analysis of in vitro transcribed (IVT) has become an essential part of biotherapeutic workflows. Discover a high-sensitivity kit made for analyzing IVT mRNA quality to advance your research.

Watch Erika Kovacs, Senior Director of Bioassay, as she discusses critical considerations for developing stage-appropriate bioassays to support complex biologics and bioconjugates on the path to IND.

Isothermal Titration Calorimetry is a powerful technique for analyzing biochemical binding events, which is crucial for understanding molecular interactions and enzyme kinetics in biomedical research.

Raman spectroscopy revolutionizes ADC manufacturing by enabling real-time monitoring of solvent clearance. Discover how it enhances process control, ensures regulatory compliance, and supports the production of high-quality therapeutics.

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.

Learn about host cell proteins (HCPs) along with how they are produced, their negative effects, how to identify HCPs in drug substances, and some technologies offering a solution for manufacturers.