Authors
Latest:
Navigating International PharmacovigilanceInternational pharmacovigilance for biotechs brings about a particular set of challenges, especially for small companies, which face the same rigour as large pharma companies.
Latest:
Automating Glycoprotein Analysis for Vaccine ManufactureOne can improve method precision and productivity by replacing one step in sample preparation with an automated approach.
Latest:
Scale-up and Tech Transfer: From Development Lab Studies to Commercial ProductionAdherence to detail and thorough project management are required for successful tech transfer and scale up.
Latest:
The Value of Pharmacopeial Reference StandardsThis article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS.
Latest:
Nanoparticles for Drug DeliveryOn Demand Webcast Nanoparticles have unique properties that are manipulated to create novel solutions, such as innovative drug delivery systems seen in today’s Covid-19 mRNA vaccines. This webinar explores the analytical techniques used for nanoparticle characterization and its growing significance in drug delivery systems.
Latest:
Industry 1VQ Solutions: Changes That Bring an Additional Restriction on the Product Compared to Registered ConditionsA case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect.
Latest:
Novel Formulations and Line Extensions with Soft Capsule TechnologyAdvancements in soft capsule technology can enable the development of soft capsule formulations, which are becoming the preferred method of oral administration.
Latest:
The Need for Speed: How Operation Warp Speed Shifted the Pharma IndustryA new focus on speed to market creates challenges for facility design and construction.
Latest:
Accelerating Project Delivery with a Lean Alternative to DBBLean delivery offers a promising solution to supply and manufacturing bottlenecks by integrating project teams early on and widening the team’s field of view.
Latest:
Guidelines for Selecting Normal Flow FiltersProper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production.
Latest:
Put a Cap on CAPAsData may be used to improve (or remove) a corrective action/preventive action.
Latest:
Improving Tablet Quality with Compression to Equal Force TechnologyTraditional tablet presses do not measure tablets' tensile strength, yet this characteristic strongly influences tablet quality. The author describes a compression technique that accounts for tensile strength and produces tablets with consistent weight and disintegration time.
Latest:
Adaptable Formulation Development Strategies for Today with a Focus on TomorrowWesley Tatum, PhD (Principal Engineer, Process & Product Development, Serán Bioscience) shares insights surrounding formulation and process development that focus on the future of the industry.
Latest:
Reducing Packaging Costs for Prefilled SyringesBlow-fill-seal (BFS) technology presents an economical option for single-unit dose delivery of vaccines.
Latest:
Fabrication Modulation of Zein-based Fibers for Oral Delivery of HydrochlorothiazideThis study suggests that using a simple centrifugal method can produce a natural polymer-blend molecule that can successfully be used as an oral delivery mechanism for poorly soluble drugs.
Latest:
Reinvesting in European ManufacturingCOVID-19 has brought to light the issues of European manufacturing capabilities, leading industry to question whether it is now time to reinvest in domestic medicines supply.
Latest:
KinetiSol® Technology: Disrupting the Solid Amorphous Dispersion LandscapeElizabeth Hickman (Chief Business Officer, AustinPx) explains the company's approach to improving bioavailability, highlighting KinetiSol technology.
Latest:
Inside USP: USP Metals Testing: A Workshop ReportAttendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients.
Latest:
Strong Quality Culture: A How-To for Busy ManagersBuilding employee participation and forming good habits contribute to a company-wide quality culture that pays off.
Latest:
How To Identify The Right Outsourcing Partner In Asia–PacificHow to find the right partner in Asia–Pacific is a very complex question and there is no uniform answer.
Latest:
EPCAM: A Strategy to Enable Manufacturing-Process Control TransformationEnterprise process control and management (EPCAM) is a new strategy for healthcare manufacturers based on recent process-control breakthroughs in the electronics industry.
Latest:
Solving the Insoluble: Webinar on the Science and Application of the Dispersome® TechnologyWebinar Date/Time: Tue, Nov 12, 2024 9:00 AM EST
Latest:
Supplementary Handwashing Techniques to Improve Hand HygieneA fluorescence test method was used to visually evaluate handwashing efficacy. Difficult-to-clean areas on skin such as skin folds and webbing between fingers were identified; specific washing techniques to address problem areas are proposed.
Latest:
Rapid Sterility Methods for CAR T-cell TherapiesA combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.
Latest:
Capping and Manufacturing Strategies for Increasing mRNA Potency and Reducing CostsIn vitro transcription (IVT) is often used to make mRNA, and in co-transcriptional capping an analog cap can be used to cap the mRNA. This paper reviews the recent history of capping analogs in addition to a state-of-the-art approach to improve protein expression.
Latest:
Transforming CDMO partnerships through qualityThis whitepaper explores the criteria for defining true quality in a CDMO partnership, including multiple product, process, and relationship variables
Latest:
Revolutionizing Biomanufacturing: The Digitalization AdvantageDigital transformation allows for smarter and connected biomanufacturing operations.
