Authors
Latest:
Optimizing Loss-in-Weight Feeding of Poorly Flowing MaterialsPrior to use in a continuous manufacturing system for oral solid dosage forms, loss-in-weight feeders need to be tested and validated to understand the performance capabilities of a given material–feeder combination. In this article, the proper strategy for set-up and optimization of a loss-in-weight feeder is demonstrated for a range of materials. The optimized set-up of the feeders was demonstrated to provide suitable performance for even the most challenging, poorly flowing materials.
Latest:
Capturing The Advantages Of Co-CrystalsHow can crystal engineering and pharma sciences be combined to enhance the clinical performance of drugs?
Latest:
Shining a Light on the Long Shadow of Subjectivity in Quality Risk ManagementThis article explores the emergence of subjectivity in ICH Q9 (R1).
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:
Selecting a CMO Partner for Sterile Injectable ManufacturingFor tech transfer of sterile injectables, vetting CMO partners means more than availability of facilities or the equipment, CMO partners should offer end-to-end support
Latest:
Early-Stage Considerations for the Manufacture and Delivery of VaccinesAlthough vials and prefilled syringes have different advantages, both find use in vaccine fill/finish.
Latest:
Validating Single-Use SystemsThere are a number of validation approaches that can be adopted for single-use systems - all of which incorporate an established approach.
Latest:
Clinical And Cost Considerations Of Developing A BiosimilarBoth biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.
Latest:
A Four-Phased Approach for Evaluating a Quality Risk Management ActivityUsing the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.
Latest:
Method Development and Impurity Control in Late-Phase API ManufacturingOnce APIs move into later phases of development, an advanced impurity control strategy is vital and demands a comprehensive analytical methods approach.
Latest:
Running a Marathon in Flip-Flops – Part 2: The Value of Incorporating Prerequisites into Equipment QualificationEquipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective.
Latest:
Manufacturing OSD Forms: Key Trends Shaping the IndustryThe latest manufacturing technologies are essential for helping pharmaceutical formulators meet up-and-coming trends in OSD treatments.
Latest:
Reducing Packaging Costs for Prefilled SyringesBlow-fill-seal (BFS) technology presents an economical option for single-unit dose delivery of vaccines.
Latest:
QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract ManufacturersQMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.
Latest:
QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract ManufacturersQMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.
Latest:
Formulation of Sustained-Release Ketorolac Tromethamine PelletsThe authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.
Latest:
Stability Studies: An Essential Step for Quality Management in Drug DevelopmentSufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.
Latest:
An Alternative to the USP Disintegration Test for Orally Disintegrating TabletsThe authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.
Latest:
REACH: has the cloud of confusion cleared?The pharmaceutical industry must understand its responsibilities to improve the safety of chemicals as defined by the REACH initiative.
Latest:
Tackling Cybersecurity Challenges in Legacy SystemsOngoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.
Latest:
Implementing Data Integrity Compliance in a GLP Test FacilityConsider how to apply ALCOA+ to a building management system in non-clinical laboratories.
Latest:
Automated Inspection of Pre-filled Syringes and Biologics During Fill/FinishShifts in pharmaceutical packaging have spurred tremendous growth in the pre-filled syringe fill/finish industry.
Latest:
Self-Emulsifying Drug Delivery SystemsThis review article explains how self-emulsifying drug delivery systems can increase the solubility and bioavailability of poorly soluble drug.
Latest:
Empowering Pharmaceutical Quality Control Laboratories through Strategic Change ManagementChange management is central to the evolution of quality control laboratories, but what factors can maximize patient outcomes?
Latest:
BioSpectra Announces Launch of New Class 6 Manufacturing SuiteBioSpectra Launches Class 6 Manufacturing Suite for Sterile filtered, GMP bulk Solutions, utilizing sterile, SUT packaging. First product launch: 5M NaCl solution made with WFI and multi-compendial salt.
Latest:
Looking Ahead to Factors Shaping Market ActivityDespite the market challenges caused by COVID-19, M&A activity in the life sciences sector is recovering well.
Latest:
Evaluating the Impact of Fatty Alcohols on Permeation of Clotrimazole from Topical CreamsStudy results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.
Latest:
Dose Administration, Compatibility, and Clinical Usability of BiologicsWebinar Date/Time: Mon, Nov 18, 2024 11:00 AM EST
Latest:
Navigating the Formality Spectrum in ICH Q9(R1)The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.
Latest:
Viral Vector API Characterization of Product-Related ImpuritiesFDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.
