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s CDC Vaccine Committee Overhaul for the Pharmaceutical Industry June 10, 2025 By Christopher Cole News Article The dismissal of all 17 members of the Advisory Committee on Immunization Practices has far-reaching impacts for the industry and beyond.
In this exclusive Drug Digest video, Adi Kaushal from Lonza summarizes the current state of the oral solid dosage market, identifies the main challenges to drugdevelopers, explains how CDMOs are leveraging expert techniques to improve OSD bioavailability, and looks into the future of advancements in drug delivery.
During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drugdevelopment. What are the trends affecting drugdevelopment today?
As drugdevelopment professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are the main challenges quality assurance and compliance professionals face during the drugdevelopment and review process?
Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).
In this episode of Drug Digest, Pharmaceutical Technology’s European/Senior Editor, Felicity Thomas, chats about the trends shaping solid dosagedrugdevelopment and manufacturing with Jan Vertommen from Lonza and Dave DiProspero from CRB Group.
According to a 2021 study by the Tufts Center for the Study of DrugDevelopment, the average cost to develop a new drug is a staggering $2.6 A robust patent strategy often involves filing multiple applications at different stages of drugdevelopment. billion[1].
The technology is an additive manufacturing process which enables the development and production of complex formulations and geometrical structures of oral dosage forms to optimise the release profiles of common pharmaceuticals in addition to new drugdevelopments.
3D screen printing provides innovative drugdevelopment capabilities that are difficult or impossible to achieve with traditional methods, including complex multi-layered formulations, precision control over drug release profiles, and near-endless possibilities in the geometric shaping of dosage forms.
As environmental concerns continue to intensify, the pressure on the pharmaceutical industry to reduce its overall environmental impact, particularly in final dosage forms, is growing proportionately. Lonzas comprehensive sustainability approach spans the entire value chain, from raw material selection to end-of-life solutions.
News All News Bio/Pharma News Publications All Publications PharmTech PharmTech Europe Resources Marketplace ICH Q9 Revision: A Comprehensive Resource on Quality Risk Management Peer-Reviewed Research PharmTech Products Pharma Insights Sponsored Podcasts Sponsored Videos Sponsored eBooks Whitepapers Webcasts Multimedia All Videos Ask the Expert Behind (..)
The company informed that it is equipped to support the clinical manufacturing of a wide range of dosage forms, including oral solids, liquids, topicals, and films. We look forward to leveraging these capabilities to support our customers’ drugdevelopment needs, enabling them to bring life-changing medicines to patients worldwide.”
With this highly marketable dosage form, scientists can effectively formulate poorly soluble drugs and supplements, while reducing development time and costs.
How the trade tariffs are fueling the shift back to oral solid dosage (OSD) products like tablets and capsules. Learn more about: Techceuticals and PharmParts, value-add businesses that focus on novel technologies, comprehensive training, and simplicity for CDMOs.
Drugdevelopment is already a difficult endeavor, with the vast majority of R&D efforts failing to produce a market-worthy product. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S. While this process is essential, it’s also slow, expensive and unpredictable.
This executive summary focuses on dose-flexible manufacturing strategies and their role in drugdevelopment. However, flexible dosing strategies are often neglected or not prioritized early in development.
The 31,600 square meter facility produces some 40 million finished solid dosage forms each year, including tablets, capsules and pellets. The acquisition will strengthen the CDMO’s position in the Netherlands, where it already owns a manufacturing facility in Bladel and an injectable drugdevelopment centre in Leiden.
Achievement of the first dose in human patients is a “milestone” for AI-driven drug discovery and drugdevelopment , stated Feng Ren, PhD, co-CEO and Chief Scientific Officer of Insilico Medicine. In February 2021, the small molecule drug INS018_055 started a first-in-human study for IPF in November 2021.
HPAPIs may now represent more than 30% of the drugdevelopment pipeline. Within that figure, GlobalData estimates that around 60% of pipeline HPAPIs are developed to target oncology. Nowadays, you have drugs against cancer which have a very high impact even at a very low dosage.”.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a first-of-its-kind trial to run this year to test psychedelic drugs as a treatment for major depressive disorder (MDD). The clinical trial will combine dosages of a new psilocin-based drug with specialist therapy.
Paradigm Shift in DrugDevelopment: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.
To help improve adherence in children, drugdevelopers need to consider innovative new dosage forms that can deliver flexible and convenient medications for young patients.
But to overcome the challenges of adherence in children, drugdevelopers need to consider innovative new dosage forms that can deliver flexible and convenient medications for young patients.
Chromatography can be used throughout the drugdevelopment process, from the identification od potential drug candidates (with HPLC enabling high throughput screening) to ensuring drug formulation purity, analysing the bioavailability and release time of novel drug formulations to determine dosages to devising manufacturing techniques.
This proposal is clearly intended to address difficulties in formulating generic drugs with the same quantity and quality of inactive ingredients as required by regulation for certain dosage forms. “FDA FDA believes this change would effectuate timelier and more cost-efficient generic drugdevelopment.”
Pharmaceutical solid dosage forms are the most popular in the pharmaceutical industry and are one of the most used drug delivery methods across patient groups. Growth of oral solid dosage contract manufacturing in the pharmaceutical industry.
There are so many different types of careers within the field of pharmacy—from research and drugdevelopment to pharmacy informatics! And when the medication was delivered to her home, she realized the dosage no longer matched her regimen. This patient received a 30-day supply of insulin before discharge.
The lack of measurability in neurological diseases plagues pharma every step of the way when it comes to drugdevelopment. Just recruiting for a trial of a drug that’s meant to intervene at an early stage of Parkinson’s or Alzheimer’s is difficult, because patients are almost never diagnosed until they’re symptomatic.
By: Mayuri Mutha, Senior Manager, CMC Development & Project Management Joseph Sclafani PhD, Director, CMC Development & Project Management Drugdevelopment is a complex, expensive, and multistage process which could take 10 to 15 years to bring a new molecule from discovery to commercialization.
WuXi STA , a subsidiary of WuXi AppTec, has announced that its first continuous manufacturing ( CM ) line for oral solids is in operation at its drug product site in Wuxi city, China. A report has estimated that the oral solid dosage (OSD) contract manufacturing market will be valued at $54.7 Oral solids. billion by 2030.
With a focus on optimising patient experience with next-generation oral dosage forms, the US facility complements the cutting-edge research activities of Roquette’s existing pharma innovation centers in France and Singapore. Expert training, troubleshooting and scale-up advice will be priorities at the facility.
Nicklas Westerholm, the CEO and president of orphan drugdeveloper Egetis Therapeutics, says disease awareness amongst paediatric neurologists and endocrinologists is low for MCT8 deficiency. The FDA will weigh the concerns and benefits of this drug before its PDUFA date in October.
It guarantees delivery of the right drug and the right dosage at precisely the right time , tailored specifically for that person. Drugdevelopers must establish stable, robust, and cost-efficient manufacturing processes, especially for rare disorders with small patient populations and limited therapeutic options.
But what are the key potential changes and how could they impact drugdevelopers and manufacturers? He noted that within the proposals, there is likely to be a differentiation in incentives for drugdevelopment in the orphan and unmet medical need areas. Key areas of potential legislative change. Future outlook.
The potential to use these scientific breakthroughs to make a real difference to patients’ lives is what drives many highly skilled scientists to the world of drugdevelopment. Yet commercialising a drug is no easy journey, hence why just 10% of new drug candidates succeed in making it to market.
The dose form manufacturing follows API manufacturing to produce the final dosage form (FDF such as tablets and injectables. These companies offer services such as formulation development, process optimisation, analytical method development, qualification, validation and testing, regulatory guidance and several other solutions and products.
eligible dosages, how the drug is administered, and frequencies of drug intake). In the general case, RCTs are the optimal approach to clinical research and drugdevelopment. Various sophisticated methods are possible and sensitivity analyses should be applied to check on the robustness of results. Discussion.
The traditional model of drugdevelopment and healthcare delivery is undergoing a seismic shift, with patient engagement emerging as a critical factor in achieving better health outcomes and driving innovation. This change is further driven by major regulatory bodies emphasizing Patient-Focused DrugDevelopment (PFDD).
a) It has no impact b) It improves medication taste c) It simplifies dosage instructions d) It provides discounts on medications 9 / 20 According to a study in the Journal of General Internal Medicine, what percentage of patients feel rushed during doctor's appointments?
Given the plethora of new chemical entity (NCE) candidates, pharmaceutical research groups frequently face challenges when selecting the most promising candidate for development purposes. With all this in mind, how do drugdevelopers know which strategy and approach is right for their molecule at this early stage?
This makes early R&D less risky, as many lead compounds are discontinued due to inadequate pharmacokinetic profiles and require excessively high dosages to be pharmaceutically active.
Compaction simulation is arguably the most important when dealing with oral solid dosage forms. The single-punch tableting press enables drugdevelopers to test formulations at full production speed, replicating the parameters of all types of industrial rotary press.
For Skyepharma, a CDMO specialising in oral solid dosage forms, notable reductions in costly product waste was one advantage. Versatility Finding a versatile R&D tablet press is key for flexible drugdevelopment. Testing a formulation on MEDELPHARM’s single-punch tablet press required just 0.9kg of powder.
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