By co-expressing Protein A with the protein of interest, the work proposes to reduce the abundant cost of chromatography resins with a one-pot purification approach.
- The Systems And Choreography Needed For Grade B ATMP Material Transfer
- Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
- Immobilized Enzymes Promise Alternative To Cyanogen Bromide's Toxicity
- What If The U.S. Government Stopped Funding Biotech?
- Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
- Generative AI Can Write The Code, But Who Builds In The Quality?
- UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
EDITOR'S DESK
-
From Biology Grad To Manufacturing Guru
Stephanie Wimberly graduated from Howard University in 2012 with a degree in biology. What was next? An online search turned up an intriguing area – pharmaceutical manufacturing. “It was manufacturing,” she thought, “but I could still help patients." It was a fortuitous start. This young female professional with a penchant for helping others started a manufacturing career that has wound through GSK, and leadership roles at Shire/Takeda. Now as a manufacturing consultant, here is her advice for manufacturing outsourcing, and careers.
AbbVie's head of biologics purification development and digitization teams, Moiz Diwan, Ph.D., and independent technology consultant Kat Kozyrytska share their thoughts on AI and smart technology adoption in this recap of the Bioprocess Online Live event, “How Digital Tools Are Accelerating Biopharma Development.”
Bioprocess Online's chief editor, Tyler Menichiello, reflects on the year and provides a preview of what to expect in 2026.
Chief Editor Louis Garguilo says he's sure some readers will smirk at our headline. CDMOs are running a business; they may attempt to treat all customers equally, but they focus where the most financial gain is. That's usually with bigger clients. Nonetheless, according to a very experienced outsourcing professional, there's nothing humorous here at all.
New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.
GUEST COLUMNISTS
-
The Systems And Choreography Needed For Grade B ATMP Material Transfer
Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.
-
Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.
-
Immobilized Enzymes Promise Alternative To Cyanogen Bromide's Toxicity
Proteases may be more expensive up front, but the benefits of cutting out a highly toxic substance quickly add up when disposal and environmental safety costs go down.
-
Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
Eli Lilly and Company's projects in the U.S. include greenfield sites where little infrastructure exists. Here's how the company's approaching the challenge.
-
Generative AI Can Write The Code, But Who Builds In The Quality?
Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.
-
UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.
-
February 2026 — 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.
-
COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy
Problems emerge when development, manufacturing, and clinical priorities fail to converge in cell and gene therapy development.
BIOPROCESSING WHITE PAPERS
-
The Roadmap To Asset Performance Management In Life Sciences
Find out how asset performance management boosts reliability, compliance, and efficiency in life sciences, which guides organizations from reactive fixes to predictive optimization.
-
Performance Characteristics Of The Mobius® ADC Reactor For Conjugation10/22/2024
Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.
-
Advancements In Microbial Manufacturing Of Biopharmaceuticals9/26/2024
Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.
-
Stopper Migration In Frozen Pre-Filled Syringes10/16/2024
Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.
-
Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes4/8/2025
The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.
-
Overcoming Challenges To High-Concentration Formulation Development3/25/2025
Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.
BIOPROCESSING APP NOTES & CASE STUDIES
- Taking The First Steps Towards Digitalizing Biopharma Development
- Bioprocess Online's 2025 Editorial Reflections
- FDA Releases Draft Guidance To Accelerate Biosimilar Development
- Supporting The Next Generation Of ADCs
- AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing
- On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration
- On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing
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.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Scaling MSC Therapies: Overcoming MSC Manufacturing Risks And Barriers
- A Gentler Workflow: Fc-fusion Protein Purification With Mixed-Mode And Anion Exchange Chromatography
- Applying AI And Rapid Prototyping To Media And Process Development
- Global Manufacturing Excellence Across Quality, Efficiency, And Cost Of Goods Sold
- Ensure Successful Viral Clearance
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 04.03.26 -- New Podcast Episodes: Regenerative Skin Therapy, Orally Available Biologics, Regulatory Flexibility In CGT, and More
- 04.03.26 -- Scaling Regenerative Medicine Production With PolarityBio's Nikolai Sopko
- 04.03.26 -- STREAM Edition: Trends In FDA FY 2025 Warning Letters
- 04.02.26 -- Automation That Delivers: From Liquid Handling To Cell Lines
- 04.02.26 -- FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address