Newsletter | February 6, 2026

02.06.26 -- Reimagining HACCP And Other Process Flow Risk Analysis Methods

INDUSTRY INSIGHTS

Ensuring AI Compliance In Life Sciences: 5 Critical Requirements

Life sciences manufacturers face growing pressure to adopt AI while staying compliant. Discover five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.

Helping Deliver A Patient-Centric Future For OSD Manufacturing

Drug developers and manufacturers must address several key challenges, including formulation complexity, improving bioavailability of poorly soluble compounds, and optimizing drug release profiles.

The Importance Of A Multifaceted Approach To Containment

Risk assessment is integral to manufacturing processes, particularly in drug production, and having effective containment strategies can help identify potential hazards and ensure worker safety.

FEATURED EDITORIAL

Reimagining HACCP And Other Process Flow Risk Analysis Methods

Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

INDUSTRY INSIGHTS CONTINUED

AI Predictive Maintenance Prevents Batch Loss And Production Shutdown

AI-powered predictive maintenance with wireless vibration sensors prevented costly batch loss and production shutdowns in manufacturing by detecting equipment issues before failures occurred.

The Art And Science Of Topical Formulations

Chief Scientific Officer Jon Lenn discusses the balance of art and science in topical formulation development, emphasizing advanced skin models for optimized delivery, activity, and product stability.

Target Product Profiles And Phase 1 Clinical Plans: Laying The Groundwork

By integrating scientific rigor, regulatory foresight, and market awareness into early-stage planning, companies can leverage a robust TPP to optimize decision-making and development.

SMB Technology: Optimizing API Purification

Explore how Simulated Moving Bed (SMB) technology can enhance API production while overcoming common misconceptions about chromatographic purification.

Bridging The Gap Between Product Readiness And Equipment Availability

See how manual precision at scale bridges packaging gaps, accelerates product launches, and ensures uninterrupted supply to deliver quality when automated equipment isn’t yet operational.

HVLD Technology Pre-Filled Syringe Inspection

Advanced HVLD technology delivers non-invasive, deterministic inspection for pre-filled syringes. Learn how this method improves reliability and patient safety compared to traditional approaches.

Optimizing Monitoring: The Science Of Particle Loss

Uncover how tubing configuration impacts compliance under Annex 1, using evidence-based guidance, risk assessment tools, and practical strategies to strengthen contamination control.

A Closer Look At Multi-Lane Checkweighing In Pharma

Find out how multi-lane checkweighing boosts operational efficiency, ensures accurate dosing, and simplifies changeovers, making it ideal for applications like dual-chamber sachets.

The Challenges Of Moving A Bioconjugate From Clinic To Market

Working with a partner that provides a one-stop shop for bioconjugate development and manufacturing helps prevent missteps that threaten the delivery of life-saving drugs to patients who need them.

Unlock Smart Production: The Key Role Of Checkweighing

In today's fast-paced production, precision checkweighing is crucial. Gain insight into how smart algorithms, real-time analysis, and automation optimize performance and minimize downtime.

Formulation Strategies For Enabling "Undevelopable" Compounds

Enhance the bioavailability of poorly soluble drugs with a platform that produces dense amorphous dispersions, outperforming traditional MBP methods in pharmacokinetics and dissolution.

SOLUTIONS

Developing A mAb For A Small Biotech Developing Precision Medicines

Enhanced Intelligent Batch Records

3-Bucket Mopping System - Correct Mopping Protocol

Reusable PCD Designed For Routine Monitoring

Our Small Molecule Development And Manufacturing Experience

Manufacture High-Quality Products With Streamlined Compliance

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