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EDITOR'S DESK

Experts' Advice On Facility Design And Construction
This is a review of the Pharmaceutical Online Live event “Facility Design And Validation Considerations For Drug Manufacturers," which featured industry experts Erich Bozenhardt and Herman Bozenhardt, as well as process architect Fred Grossfeld.

Tariffs Won't Stop Drug-Candidate Licensing From China Biotechs

According to Global Data, the total deal value of U.S. licensing of innovator drug candidates from Chinese biopharma companies has surged since 2020. This is an area way upstream of the current tariff focus on manufacturing. But how this R&D trend and those tariffs play out will impact your U.S.-based CDMOs.

From BPI West: A Roundtable Discussion On Continuous Manufacturing

Process Development experts share their thoughts on continuous manufacturing at this year's BPI West, touching on its benefits and present barriers to adoption.

From BPI West: Key Challenges And Benefits Of Continuous Manufacturing

Continuous manufacturing was a hot topic of conversation at this year's BPI West. AstraZeneca's Ken Lee, Ph.D., weighs in during an exclusive interview with Bioprocess Online.

From BPI West: An Upstream Scientist's Advice On Target Glycosylation

Bioprocess Online spoke to an upstream scientist at Bristol Myers Squibb during this year's BPI West. Here's what he had to say.

GUEST COLUMNISTS

Navigating Data Management Requirements For Sterile Manufacturing
Contamination control strategies are rooted in representative and trustworthy data, but companies still do a poor job at maximizing their use of data to optimize.
Multispecific Trial Supply Stability Hinges On CDMO Agility
Naya's CEO describes the dynamics of producing a complex therapeutic for clinical trials on another continent, and how choice of CDMO plays heavily into that strategy.
The Promise And Challenges Of Cell-Free Protein Systems
CFPS use cell lysates or purified enzymes to synthesize proteins. They have emerged as a promising alternative to production with living cells.
Bracing For The Impact Of The Federal Workforce Reduction
The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.
Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements
This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.
Demystifying The Common Technical Document For Global Submissions
The CTD's Module 3 is notoriously complex and challenging. Here are strategies for an easier path toward CMC submission readiness.
May 2025 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
The Matryoshka Model: The New Face Of Contract Packaging In Pharma
Contract packaging organizations are the outer layer of the pharmaceutical Matryoshka (the iconic Russian nesting doll): the final form that contains within it a series of intricately crafted parts.

BIOPROCESSING WHITE PAPERS

Supplier Quality Is Only As Strong As Your Weakest Link
Your supply chain is only as strong as its weakest link. 52% of organizations attribute recalls to supplier-related issues, and proactive supplier quality management is essential to protect your brand.

The Complete Guide To Immunohistochemistry
9/24/2024

Immunohistochemistry (IHC) is a tool for visualizing the distribution and localization of antigens within tissue sections. Learn about IHC sample preparation, detection and amplification systems, and more.
State Of Validation Report 2024
12/17/2024

Explore trends in compliance, audit readiness, digital systems, process efficiencies, emerging KPIs, and the adoption of Pharma 4.0 technologies.
ATMP Cryopreservation Done Right - Best Practice In Small Volume Cryo-Freezing
3/11/2025

Explore best practices for cryopreserving small-volume advanced therapy medicinal products (ATMPs), emphasizing sterility, cell viability, and efficiency using innovative single-use systems and aseptic connectors.
Transitioning From Using RUO To cGMP Chemicals For Clinical Trials
10/17/2023

Learn about the common challenges and risks associated with accelerating your molecule's timeline from lab to clinic, along with important supply chain considerations for emerging biopharma companies.
Bench To Bedside: Trends In Regenerative Medicine
7/19/2024

Discover the promising capabilities of regenerative medicine. Learn about four advanced techniques that can restore damaged tissue and offer hope to patients with severe conditions.

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BIOPROCESSING APP NOTES & CASE STUDIES

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BIOPROCESS ONLINE CONTENT COLLECTIONS

This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.