Expert Content & Resources
Case study: Modeling polymor interactions to improve amorphous dispersion design
In this case study, OSDPredict™ narrowed formulation options early, focusing development on the most viable strategies which reduced experimental burden and conserved valuable materials.
The Last Mile of Digital Implementation: A Technical Framework for Turning Clinical Technology Adoption Into Measurable Value
As clinical trials become increasingly digitally enabled, organizations must look beyond successful technology deployment to determine whether new tools are delivering measurable value. This article presents a five-layer framework for evaluating technical fitness, workflow integration, adoption, data reliability, and operational outcomes to help translate clinical technology investments into better trial execution and evidence.
FROM ASSESSMENT TO SUSTAINABLE ACTION - Circular Economy Strategies & Practical Routes to Lower-Impact Medical Devices
AstraZeneca and Novo Nordisk have both committed to science-based net-zero across their full value chains by 2045. However, decarbonizing manufacturing alone leaves most of the footprint untouched. Meeting these net-zero targets requires changes to the products themselves, the devices that deliver them, and the systems built around them, including the reprocessing and reuse networks. The route to a more sustainable device is not the same for every product, and the single biggest determinant of what is achievable is where a device sits in its product development lifecycle when sustainability is first considered.
Managing Fragmented Small-Molecule Supply Chains Through Strategic Secondary Bulk Packaging
As small-molecule manufacturing becomes increasingly fragmented across regions, specialist facilities, and CDMOs, every product handoff introduces new opportunities for delay and variability. A strategic bulk secondary packaging approach can help standardize product handling, improve operational control, and strengthen resilience across complex pharmaceutical supply chains.
Four Myths About Embedded CMOs, Busted
Are your perceptions of the CMO marketplace serving your drug program—or holding it back? If you’re looking for a contract manufacturer to bring your therapy to market, you’re far from alone. Demand for manufacturing services is shaping the pharma Contract Manufacturing Industry, with analysts predicting a growth rate of nearly 7% per year until 2028. In such a competitive market, how should a project sponsor navigate the choice between one CMO and another? To find the answer, many sponsors begin by distinguishing between typical stand-alone CMOs and an embedded CMO that operates under a parent company—AbbVie, in the case of AbbVie Contract Manufacturing (AbbVie).
How Molecular Biology Technologies Are Transforming Discovery and Development
Advances in PCR, sequencing, automation, and molecular analysis are helping biopharma teams accelerate discovery, improve data quality, and reduce development risk. Thermo Fisher Scientific’s Dr. Anjali Shah discusses how integrated molecular biology workflows are evolving to support increasingly complex therapeutic modalities.
SPECTROSCOPY - High-Precision Tunable Laser Spectroscopy: A “Library-Based” Approach to Quantitative Bioprocess Analytics
The accuracy and speed of analytical measurements play a critical role in biopharmaceutical development and manufacturing. In particular, the ability to quantify both active pharmaceutical ingredients (APIs) and formulation excipients – such as buffers, amino acids, sugars, and surfactants – is essential for ensuring product quality, process consistency, and regulatory compliance.
COLD CHAIN SUSTAINABILITY - Cold Front: The Growing Need for Controlling Cold Storage Energy Costs
The pharmaceutical and biotech industries are not only one of the most prominent users of cold storage solutions today but are also one of the market’s most important growth drivers. Several factors, including the rise of temperature sensitive drugs, growing energy prices, and increasing regulatory scrutiny are inevitably compelling the pharmaceutical industry to consider its use of the global cold chain with sustainability in mind.
Monoclonal vs Polyclonal Antibody Production – Explained Step by Step
Antibody-based therapeutics have reshaped modern medicine. With demand soaring, choosing the appropriate production path can save months and millions.
According to Grand View Research, the global therapeutic antibody market will surpass US $2.21 billion by 2030.
Based on our expertise in monoclonal antibody production, let’s take a look at how each antibody type is produced, contrasts their timelines, costs, and use-cases, and ends with clear next steps to keep your project moving.
Improving bioavailability using predictive modeling for solubility enhancement
In this case study, predictive modeling with the OSDPredict™ platform was used to prioritize optimal formulation strategies for a program facing low-solubility challenges. This approach improved exposure and supported accelerated advancement toward Phase I clinical trials.
Why Assembly and Packaging Have Become the Critical Path to Drug-Device Launch
The pharmaceutical industry has spent decades refining drug discovery, biologics manufacturing and fill-finish operations. However, for many combination products today, the greatest risk to launch timelines no longer sits upstream in formulation or production.
BullFrog AI: Applying an End-to-end AI Workflow to Improve Clinical Development
BullFrog AI Founder and CEO Vin Singh discusses how the company’s end-to-end AI workflow prepares complex clinical data, identifies disease drivers and patient subgroups, and turns those insights into explainable recommendations designed to improve clinical development decisions.
Why NAMs Took Decades to Arrive – and Why iPSCs are Making Them Possible
When US and European regulators acted in recent years to support the use of animal model alternatives for drug development, reactions were mixed. There is broad acknowledgement regarding the limitations of animal-based disease models and their inability to fully recapitulate human biological complexity, contributing to a high clinical failure rate, and so there was true excitement for the possibilities.
Navigating FDA QMSR in 2026
For years, many medical device manufacturers approached FDA inspections through a familiar lens: prepare documents, review subsystem requirements, rehearse likely questions, and demonstrate compliance against a known framework.
eBook: Understanding the Foundation of LNP Formulation Success
Lipid nanoparticles (LNPs) are one of the most significant advances in drug delivery in decades. But developing successful LNP formulations demands deep knowledge of their key building blocks: Lipids.
Avoiding Recalls: How to Ensure Sterility in Ophthalmic Products
In the wake of several high-profile eye drop recalls, we look at the challenges of achieving sterility in ophthalmic products, the consequences of failing to do so, and how AbbVie Contract Manufacturing ensures product sterility and safety.
On-Demand Presentation: Analytical Strategy & Challenges for ADC
Global Vice President of Analytical & Research Development, Scott Zugel, spoke at Veranova’s SCALE Symposium, where he outlined key analytical strategies and challenges in ADC manufacturing in the pharmaceutical industry.
America’s Next Healthcare Crisis Is Already Here - And We’re Not Ready
Bryn L. Dubin, Master’s Student at the LBJ School of Public Affairs studying health and economic policy. Dubin has federal and state legislative and policy analysis experience.
Executive Interview: Advancing Regenerative Medicine for Chronic Disease
Lance Alstodt, CEO of BioRestorative Therapies, discusses the development of its lead cell therapy candidate BRTX-100, the evolving regulatory and manufacturing landscape for autologous therapies, and how regenerative platforms could reshape treatment paradigms for chronic conditions.
The Most Underutilized Route in Drug Delivery: How Vaginal Therapeutics Are Finally Getting the Platform They Deserve
Before we dig into improved delivery methods, we need to acknowledge a more basic issue: women need more therapeutics in the first place. Persistent gaps exist across conditions that uniquely or disproportionally affect women. Gynecologic infections, endometriosis, the vaginal microbiome. Menopause, contraception, oncology.
