Newsletter | October 1, 2026

10.01.26 -- A Breast Cancer Vaccine Moves Prevention Closer To Reality

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Virtual Symposium: Developing Custom GMP Lipids: A Patient-Driven Partnership

From concept to GMP, bringing a custom lipid to production takes more than technical expertise. It takes collaboration. In this virtual symposium, Process Development and Manufacturing experts share how they worked together to navigate custom lipid design, scale-up, and regulatory challenges while maintaining quality and reliability. Discover practical insights for advancing custom lipid programs and supporting the development of next-generation LNP-based therapies. Click here for more.

INDUSTRY INSIGHTS

 

Navigating Regulatory Complexity In International Pharma Supply

Gain essential insights into QP roles, regulatory updates, and best practices for ensuring compliance, supply continuity, and safe handling of cold and frozen pharmaceutical products across the UK and EU.

 

Tech Transfer Answers: How To Successfully Onshore A Mid-Phase Project

Onshoring biomanufacturing operations is an increasingly common decision. While a mid-phase tech transfer from international to domestic CDMO can be complex, the right partner can ensure success.

 

Strengthening cIEF Method Validation With cIEF-MS

Preparing for method validation, a biopharma company needed to characterize cIEF charge variants and confirm peak identities for regulatory readiness.

FEATURED EDITORIAL

A Breast Cancer Vaccine Moves Prevention Closer To Reality

A few times in life you hear something that precipitates a pause – a reality recalibration. Like experienced by Amit Kumar, chairman and CEO, Anixa Biosciences, when he came upon a technology he thought could enable a prophylactic vaccine to prevent breast cancer – perhaps eliminate the disease like we've done for polio. He personally invested over $2.5 million, and his development/commercialization strategy is all-outsourcing all the way.

 

Why Effective CAPA Starts With Accurate Classification

An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

INDUSTRY INSIGHTS CONTINUED

 

Five Hidden Traps In Oligonucleotide Analytical Development

Oligonucleotide analytical development requires robust impurity and structural analysis. Early orthogonal testing improves stability insight, reduces risk, and strengthens regulatory readiness.

 

How To Save Significantly On Early-Phase Clinical Supply

Discover how integrated clinical supply strategies streamline early trials, reduce logistics complexity, cut costs, and ensure timely delivery of investigational products and samples.

 

High Content Imaging

Learn how high-content imaging enables deeper cellular insights, accelerates hit-to-lead progression, and enhances decision-making through multiparametric analysis.

 

A CFD-Based Hybrid Modeling Approach For pCO2 Prediction

Computational fluid dynamics and metabolic modeling predict gas transfer more accurately than volumetric metrics, improving mammalian cell culture scale-up and process control.

 

What Sterile Injectable Sponsors Need To Know

Late-stage sterile injectable manufacturing demands balancing compliance, capacity, and complexity. Early investment in validated systems streamlines scale-up and launch.

 

Advancing Through A Single-Use Facility Journey

Modular single-use facility design — combining closed processing and global standards — boosts flexibility, speeds tech transfer, and strengthens supply resilience in modern biomanufacturing networks.

 

Overcome Common Pre-Filled Syringe Challenges Through Partnership

The pre-filled syringe space is one of the fastest growing pharma sectors, offering greater patient safety and lower manufacturing costs. But pre-filled doesn’t translate to easily filled.

 

Antibody-Drug Conjugates: Manufacturing Precision Medicines

The monoclonal antibody intermediate is engineered for delivery of the linker-payload complex. Discover how storage measures ensure its quality, which is crucial for conjugation and functionality.

 

Developing New Medicines Through Artificial Intelligence

Embrace the future of drug development by leveraging AI and innovative protein synthesis technologies to accelerate the creation of effective therapies and transform patient outcomes.

 

Advancing mRNA Vaccines Through IVT Process Development

An in vitro transcription (IVT) platform enables high-yield and cost-efficient mRNA therapeutic production by leveraging data-driven process optimization and enzyme innovation to overcome challenges.

 

Streamline Biopharmaceutical Manufacturing With Versatile Platforms

View how standardized quality controls, robust analytics, and streamlined processes can improve efficiency, reliability, and scalability across the development lifecycle.

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Webinar: USP <665>: Testing Of Plastic Components And Systems Used In Pharmaceutical Manufacturing

How do you build a defensible USP <665> extraction study? This Pace Life Sciences webinar explores the risk-based framework for evaluating plastic components and systems used in pharmaceutical and biopharmaceutical manufacturing. Learn how to determine scope, assign risk, select extraction conditions, interpret extractables and leachables, and develop complete study packages that support regulatory expectations and product safety. Click here to learn more.

SOLUTIONS

Annex-1 Compliant Robotic Aseptic Powder Fill/Finish Solution

Streamline Global Regulatory Submissions

Expanding End-To-End ADC Development And Manufacturing

Manufacturing At Scale

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

 

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