Newsletter | November 5, 2025

11.05.25 -- A (Partial) Vindication For Wuxi AppTec … And Global Outsourcing

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Webinar: Advancing Topical Formulations with Innovative Preclinical Models

In this webinar, experts will explore strategies to improve drug candidate success rates by integrating robust formulation development and predictive preclinical models. Learn how comprehensive drug characterization, in vitro/ex vivo testing, and systematic formulation approaches can identify promising candidates early, reduce development risks, and align with evolving regulatory expectations to streamline development and improve overall therapeutic outcomes. Click here to learn more.

INDUSTRY INSIGHTS

The Importance Of Tablet Density Uniformity

Non-uniform density causes many tablet failures. Learn how optimizing your formulation, tablet proportions, and tooling design ensures proper de-aeration for consistent quality.

The Fusion-Based, Solvent-Free Process Disrupting Spray Drying

Review a commercially-ready process capable of reproducing spray-dried dispersions with less manufacturing complexity and environmental impact, and out-designing and outperforming spray drying.

OSD Manufacturing For Pediatrics And Other Special Patient Populations

Watch as Steven Facer, Adare's Vice President of Business Development EU/ROW, discusses the challenges of pediatric oral solid dose manufacturing and how to overcome them.

FEATURED EDITORIAL

A (Partial) Vindication For Wuxi AppTec … And Global Outsourcing

Chief Editor Louis Garguilo believes WuXi AppTec should take this as a dose of vindication. Even a partial victory. Supporters persuaded the Senate to NOT include WuXi in the BIOSECURE Act. Here’s an analysis of this current situation that can affect anyone outsourcing drug development and manufacturing.

New Guide Aims To Build Robust Framework For Digital Validation Tools

The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

INDUSTRY INSIGHTS CONTINUED

SMB Technology: Optimizing API Purification

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

Nitrosamines: Assessing The Risk To Pharma Products

Nitrosamines are a serious risk in drug products, driven by secondary amines, conducive conditions, and nitrosating agents. Understanding these factors is key to risk mitigation and patient safety.

Providing Packing And Blinding Solutions For An Innovative Drug Start-Up

Discover how a CDMO with integrated services enabled a botanical drug start-up to commence its Phase 1 clinical trial, paving the way for further advancement of its innovative botanical drug.

Spray Drying For Innovative Dry Powder Inhaler Combination Formulations

Combination therapies delivered directly to the lung by dry powder inhalants are an effective means of reducing patient burden. Read about case studies that illustrate the potential for improving care.

Investing In Capacity – API Commercial Manufacturing

A pharma company sought a CMO partner with commercial manufacturing capabilities and expertise as well as exemplary quality systems to find a cost-effective process to produce the API for a new drug.

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SOLUTIONS

From Risk To Readiness: Strategic Regulatory Support

With over two decades of insourcing experience and a global footprint across 110+ client sites, PSS delivers strategic, on-site support tailored to each client’s regulatory landscape.

Applications Of Liquid-Filled Capsules In Pharmaceutical Manufacturing

Liquid-filled two-piece capsules offer advantages like scalability, faster absorption, simpler packaging, and greater product stability. Learn more about their benefits in pharmaceutical development.

Nasal Spray Development And Manufacturing Services

See why partnering with experts with experience in complex, sensitive, and potent APIs, screening for the optimal formulation, and scaling up efficiently is vital for successful trials and commercialization.

Small Molecule Manufacturing Solutions

Consider our cutting-edge services in powder blending, encapsulation, tablet compression, and on-site laboratory testing that meet the highest standards to ensure exceptional quality and compliance.

Supporting Global Pharma Partners With Flexible, Reliable Solutions

As a leading CDMO, we specialize in the development and manufacturing of diverse dosage forms for both clinical and commercial applications, driven by a culture of innovation and commitment to quality.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. 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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