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Articles by John Baumann
11.21.25 -- AI Assesses Passion At CDMOs, But Humans Think Differently
An Overview Of FDA's Expedited Program For Serious Conditions Review additional details on the FDA expedited review programs, the incentives for obtaining such designations, and the required information/data needed to better position products in development.
11.19.25 -- We're A Virtual Biotech. CDMOs Should Treat Us As A Priority
Webinar: Extrusion-Based ASD Scale-Up: Ensuring Performance Through Process Understanding Boost your drug development success with Lonza’s upcoming webinar on amorphous solid dispersions (ASDs). Learn how hot melt extrusion (HME) can enhance bioavailability, cut costs, and scale efficiently—backed by real-world lab and pilot trials. Compare HME and spray drying while gaining exclusive insights into Lonza’s advanced capabilities and proven expertise in ASD manufacturing.
10.10.25 -- New FDA White Paper Ties Quality To Financial Benefits
Considerations In Sterility Testing And Assurance Mammalian cells play a crucial role in the biopharmaceutical industry for producing complex molecules such as recombinant proteins and monoclonal antibodies. Ensuring the safety of these products requires rigorous control of microbial contamination throughout cell culture batches and downstream processing.
08.26.25 -- The 3 Big Barriers To AMT Implementation
Advancing In Silico Predictions In Early Drug Discovery Examine a high-throughput approach that streamlines LogD measurements, offering faster and more accurate insight into compound lipophilicity to support better decision-making in early drug discovery. Data Modeling Guidebook Discover how digital transformation is revolutionizing industrial operations with smart technologies and data modeling to help optimize production, predict failures, and enhance quality.
07.22.25 -- FDA Leading The Decline Of Animal Testing
The gold standard practice of conducting animal studies for evaluating toxicity, pharmacodynamics, and immunogenicity is being challenged by innovative alternatives – New Approach Methods (NAMs). Formulation Development Of A JAK1 Inhibitor Extended-Release Tablet This scientific article presents a summary of the formulation development strategy of a JAK1 inhibitor extended-release tablet, with a focus on experimental design, data interpretation, and formulation decision-making.
Fresh Meniscal Allograft Transplantation Is Associated With Superior Functional Outcomes for Acetabular Labral Reconstruction in a Preclinical Canine Model - Brent A. Prenger, John R. Baumann, James L. Cook, Chantelle C. Bozynski, Cristi R. Cook, Aaron M.
Get full access to this article View all access and purchase options for this article. References 2. Amanatullah DF, Antkowiak T, Pillay K, et al. Femoroacetabular impingement: current concepts in diagnosis and treatment. Orthopedics. 2015;38(3):185-199. 3. Atzmon R, Radparvar JR, Sharfman ZT, Dallich AA, Amar E, Rath E. Graft choices for acetabular labral reconstruction. J Hip Preserv Surg. 2018;5(4):329-338. 4. Barrera Oro F, Sikka RS, Wolters B, et al.
01.30.25 -- Here's Why The Life Sciences Struggle To Exploit Process Knowledge
A Closer Look At Inspection Systems In Tablet And Capsule Production Walk through the rigorous inspection process pharmaceutical products undergo to ensure safety and quality, from granulated ingredients to packaging. Considerations In Selecting A Biomaterial For Implantable Smart Devices Smart implants revolutionize healthcare with embedded sensors for real-time monitoring. Polycarbonate urethanes offer biocompatibility, overcoming challenges with biomaterials for safer devices.
11.13.24 -- Aftershocks: Catalent's Leader Assures The Market
Establishing Commercial Manufacturing Services For Antibody-Drug Conjugates A significant portion of ADC projects are outsourced to CDMOs and with the continued expansion of pipelines and more commercial products reaching the market, CDMOs with plans to support commercial-scale ADC manufacturing need to invest in facilities and set up processes to handle complex supply chains and ensure efficiency, quality, and safety.
07.24.24 -- Outsourcing At Cerus: Blood, Sweat … And FTEs?
Webinar: Innovative AI-Driven Solutions to Address the Growing Complexity of APIs Discover CASP technologies - the award-winning AI and vast data that propel Lonza’s leading predictive retrosynthesis technology, used to mitigate the impact of rising small mol API complexity and its resulting longer syntheses.
07.23.24 -- Beware AI Hallucinations
Webinar: Innovative AI-Driven Solutions to Address the Growing Complexity of APIs Discover CASP technologies - the award-winning AI and vast data that propel Lonza’s leading predictive retrosynthesis technology, used to mitigate the impact of rising small mol API complexity and its resulting longer syntheses.
06.11.24 -- Sorting Through Winners And Losers Of New Technology In Pharma
Adare has over 30 years' experience transforming the challenges of pediatric drug formulation into product solutions that drive compliance. Our scientists combine expertise, integrated services, and specialized technology platforms to develop optimized pediatric formulations that provide ease of application and improved patient outcomes. From NCEs to product lifecycle extensions, we can deliver flexible and convenient medications for your youngest patients.
Application Of A Novel Temperature Shift Process For Particle Engineering
By John Baumann, head of R&D Advanced Engineering Technologies – Small Molecule, Lonza Spray drying of amorphous dispersions improves solubility and bioavailability that enables supersaturation in the intestine, driving higher rates of absorption when compared to crystalline drug forms.
A standardised method for improving patient education material readability for orthopaedic trauma patients
While the National Institutes of Health and American Medical Association recommend patient education materials (PEMs) should be written at the sixth-grade reading level or below, many patient education materials related to traumatic orthopaedic injuries do not meet these recommendations.
A standardised method for improving the readability of patient education materials for total hip & knee arthroplasty patients
Orthopaedic Patient Education Materials (PEMs) related to total hip and total knee arthroplasty (TKA) have repeatedly been shown to not meet American Medical Association and National Institutes of Health recommendations for readability. PEMs that are written with too much complexity limit the ability of some readers to comprehend the material. These complex PEMs also limit the health literacy of patients, a key determinant of health status and outcomes.
01.02.24 -- Biochips: The Small Devices With Big Promise
Biochips are small medical devices with microarrays for carrying out biochemical processes. Biosensors enable the screening of different biological materials such as enzymes, proteins, DNA, biological molecules, and more, and are used in drug discovery and research. They can also be implanted in the body for targeted drug delivery or to track health data.
12.12.23 -- Baxalta v. Genentech: The Latest Case In Patenting Functionally Claimed Antibodies
On September 20, 2023, in Baxalta v. Genentech, the Federal Circuit invalidated patent claims directed to functionally claimed antibodies, finding that they failed to satisfy the enablement requirement. The author of this article is a patent attorney, and he shares the key takeaways for biotech/pharma companies going forward.
09.13.23 -- Pharma Driving ADC Market To Triple By 2030
Is the growing demand for small molecule outsourcing impeding your ability to find a reliable partner with capacity? Don’t miss Outsourced Pharma Capacity Update — a virtual event focused entirely on the available capacity and related service area capabilities, volumes, locations, and facilities of CDMOs. This multiday event is conveniently grouped by molecule type and will feature small molecule partner presentations on October 4th. Registration is free.
06.01.23 -- Not All Plate Counting Technologies Are The Same
By Tim Sandle, Ph.D. While rapid microbiological methods have advanced, most microbiology lab tests remain reliant upon assessing microbial growth on agar plates. Discrepancies with plate counting, together with the limitations of human vision, have led to regulatory concerns. This article shares the advantages of automated colony counters. Keep in mind that not all automated plate counters are the same, though — you'll want to look for important functionality.
05.01.23 -- Top Innovators In Pharma: By The Numbers
By Ed White, Clarivate Clarivate has published its 2023 list of the Top 100 Global Innovators, identifying the companies and institutions globally that have pushed the boundaries of technology and applied knowledge the furthest. To define “innovation” in this context, Clarivate uses global invention data, which includes patent applications and issued/granted patents.
02.28.23 -- Driving Sustainability In Spray Drying Through Enabling Technologies
Have you heard of ? Check it out today for access to candid interviews with top-tier executives on how they do business.
01.24.23 -- Application Of A Novel Temperature Shift Process For Particle Engineering
Have you heard of ? Check it out today for access to candid interviews with top-tier executives on how they do business.
01.02.23 -- A Methodology To Support Particle Investigations In Biopharma Products
Is Your API Ready For Scale-Up? What To Demand From Your CDMO A CDMO that can optimize your API synthesis early during technology transfer will reduce the risk of delay or failure. That will also help your molecule run more efficiently in their plant.
08.17.22 -- Heightened Standards For Satisfying Written Description In Pharma Patents
By Jonathan B. (J.B.) Fitzgerald, Ph.D., J.D., Snell & Wilmer, L.L.P. In Biogen Intl. v. Mylan, the Federal Circuit invalidated claims in one of Biogen’s patents based on its finding that a claimed dosage limitation was insufficiently described in the disclosure and, thus, failed to meet the written description requirement. Between that case and another recent case, the Federal Circuit is showing heightened scrutiny on this patenting subject.
An Injectable Containing Morphine, Ropivacaine, Epinephrine, and Ketorolac Is Not Cytotoxic to Articular Cartilage Explants From Degenerative Knees
Purpose The purpose of this study was to determine the effects of a multidrug injectate containing morphine, ropivacaine, epinephrine, and ketorolac, commonly referred to as the “Orthococktail,” on cartilage tissue viability and metabolic responses using an established in vitro model. Methods With institutional review board approval and informed patient consent, tissues normally discarded after total knee arthroplasty (TKA) were recovered.
04.07.21 -- 11 Critical Steps To Manage Solvents During API Manufacturing
By Grant Mordue, Pro-Active GMP Consulting Ltd. Manufacturers and distributors use multipurpose tankers for organic solvents for the manufacturing of APIs and associated intermediates. This presents a cross-contamination risk that might go undetected when the solvent is tested before offloading into a manufacturing site distribution system. This article explores the risks and mitigation options available to API manufacturers.
04.06.21 -- Marketo Split-Test Test 3
By Grant Mordue, Pro-Active GMP Consulting Ltd. Manufacturers and distributors use multipurpose tankers for organic solvents for the manufacturing of APIs and associated intermediates. This presents a cross-contamination risk that might go undetected when the solvent is tested before offloading into a manufacturing site distribution system. This article explores the risks and mitigation options available to API manufacturers.
Science Of Scale For Spray Dried Intermediates
By David K. Lyon, Ph.D., Senior Fellow, Research and John M. Baumann, Associate Director, R&D Speed to market is a critical aspect of developing new pharmaceutical products and scale-up—or scale-down—can play a key part in that process. Significant interest has been focused on the science of scale for spray drying, since this process is the leading technology for formulating drugs with slow dissolution rates or poor solubility, which can lead to poor bioavailability.
Science Of Scale For Spray Dried Intermediates
By David K. Lyon, Ph.D., Senior Fellow, Research and John M. Baumann, Associate Director, R&D Speed to market is a critical aspect of developing new pharmaceutical products and scale-up—or scale-down—can play a key part in that process. Significant interest has been focused on the science of scale for spray drying, since this process is the leading technology for formulating drugs with slow dissolution rates or poor solubility, which can lead to poor bioavailability.
An Engineered Platform For High-Loaded Dosage Forms Of Amorphous Solid Dispersions
By Dr. Deanna Mudie, Dr. Kimberly Shepard, Dr. Michael Morgen, John Baumann This poster outlines a novel engineered platform for the formulation of high-active-loading oral solid dosage forms containing amorphous solid dispersions (ASDs) of a rapidly crystallizing drug with a low glass-transition temperature (Tg).
The hidden controversy over online shopping
When you go online to buy clothing, furnishings, or children’s toys, you may not realize that your simple transaction has become a controversial part of a political fight that threatens to reduce consumer choice and impose chaos on small and mid-size remote sellers.
A GC's Battle With Parkinson's Gives Hope to Others by Stephanie Forshee, Corporate Counsel October 19, 2016
John Baumann worked in-house for 22 years at Exxon, Tosco and Steel Technologies. After being diagnosed with Parkinson's, he was forced to quit his dream job. Now he's a motivational speaker and author, but he still misses his days as an attorney. John Baumann loved being a lawyer. He was sure he'd be one his entire life. "I always thought I'd be one of those lawyers who worked until I had a heart attack at my desk," he says.
Emotional support animals on commercial flights: a risk to allergic patients
The Lancet's Manifesto We at believe it is our moral imperative to empower research and to grow the social impact of science. Improving lives is the only end goal that matters, and research is only relevant when it has impact on human lives. We therefore select only the best research papers, based on their quality of work and the progression they bring: the best science for better lives. Find out more about The Lancet's vision
Guest commentary: Investing in school readiness can lift families out of poverty
Few of the families in the communities and churches where I work have never taken a course in Greek mythology, but they can tell you the story of Sisyphus because they live it every day. It's an uphill struggle to make ends meet, with little hope of climbing out of poverty. Tomorrow is likely to bring another boulder pushed down on their shoulders -- a costly car repair, a sudden illness, a change in work schedule that destabilizes care for their kids -- and makes it impossible to get ahead.
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