Whitepapers
WHITEPAPER - Addressing Regulatory Challenges for Ophthalmic Combination Products
Going forward, sponsors developing ophthalmic products formulated for delivery as eye drops must be prepared to pursue development programs that address the regulatory requirements for drug-device combination products. Partnering with a contract manufacturing organization (CMO) that has experience bringing such products to market is essential…..
WHITEPAPER - Use of a Platform Formulation Technology to De-Risk Solid-State Variation in Drug Development
This white paper describes use of mesoporous silica as a porous carrier formulation technology to stabilize unstable polymorphs and to optimize solid state properties.
WHITEPAPER - Long-Acting Injectable Nanoparticle Formulations
Long acting injectable (LAI) formulations have been the subject of continued interest in the recent past due, in part, to their longer systemic circulation requiring less frequent dosing of drugs.
WHITEPAPER - Overcoming the Knowledge Gap: Long-Acting Injectables & Implantables
This whitepaper delves into the numerous benefits of long-acting drug delivery systems, including their ability to harness highly potent APIs, streamline development and intellectual property protection, and provide consistent drug release over extended periods.
WHITEPAPER - PLGA Nanoparticles - Bridging the Gap From R&D to GMP
Poly(lactic-co-glycolic acid) (PLGA) has emerged as a promising material for drug delivery and biomedical applications. Its exceptional biocompatibility, customizable degradation and release properties, and versatility have led to….
WHITEPAPER - Enhancing the Solubility of Active Pharmaceutical Ingredients Using Hot Melt Extrusion & Polyvinyl Alcohol
This white paper describes how hot melt extrusion (HME) and a specially-engineered grade of polyvinyl alcohol can be used to increase the solubility of DCS IIb molecules.
APPLICATION NOTE: Process Optimization & Preclinical Production Using the ANP System
Particle Works is thrilled to announce the launch of a new Application Note that delves into the advancement of nanoparticles as carriers for targeted drug delivery. Developing nanoparticles for this purpose can be….
TECH BRIEF – Expedite FDA Approvals With Certified Pure Materials
A key focus of the U.S. Food and Drug Administration’s evaluation of a medical device’s safety and effectiveness is reviewing its material makeup. If improperly…
WHITEPAPER - How to Mitigate Risk for Biologics During Fill/Finish Manufacturing
Aseptic processing with the highest degree of sterility assurance, filling accuracy, and quality is critical for high-value, small-batch therapies. This white paper explores the specialized…
WHITEPAPER - Extrusion-Spheronization, Engineered for Today’s Controlled Release Forms
Synchronizing and controlling API delivery, extrusion-spheronization (E-S) offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics. Manufacturing oral….
WHITEPAPER - Unique Manufacturing Challenges Associated With Sterile Eye Ointments
The manufacture of ophthalmic ointments is much more complex than the production of ocular liquid therapies and presents several unique challenges. It is essential for…
WHITEPAPER - Improve Process Economics & Enable High Protein Concentrations
What if you could achieve higher protein concentrations during downstream processing? This whitepaper spotlights how excipient combinations can enhance manufacturability and final concentration of mAb formulations.
WHITEPAPER - Purity is Paramount: Assessing N-Oxide Impurities in Lipids Used in Lipid Nanoparticle Delivery Systems
This study demonstrates that Evonik is capable of manufacturing high-quality lipids with a purity greater than 99% and a consistently low level of the N-Oxide impurity.
WHITEPAPER - Case Study-Improving Bioavailability Using PBPK Modeling & Parallel Formulation Screening
A team of bioavailability experts at Catalent used the in-house bioavailability enhancement platform, OptiForm® Solution Suite, to optimize and develop….
WHITEPAPER - Infographic-Zydis® Orally Disintegrating Tablet (ODT) vs. Standard Tablets (ST)
Catalent’s proprietary Zydis® ODT platform is backed by a large number of clinical studies. This infographic provides a high level summary of studies comparing Zydis ODT against traditional oral tablets…..
WHITEPAPER - Maintaining Sustainable Business Practices During the Energy & Supply Crisis
As we come to the end of another year, our global economy faces many significant challenges. Recently, a colleague asked me, “As a biopharma executive, which of today’s major issues are the ones that keep you up at night?”
WHITEPAPER WORKSHOP - Soft Mist Inhalers
Soft mist inhalers (SMIs) are a versatile technology suitable for the delivery of both small and complex large molecules, optimising lung deposition whilst minimising oropharyngeal deposition…..
WHITEPAPER - Accelerated API Manufacturing by Combining Early-Stage and Late-Stage Process Development
Traditionally, early-stage and late-stage process development have been done separately, with early-stage mostly focused on material production and late-stage on process intensification. As more….
WHITEPAPER - Extrusion-Spheronization, Engineered for Today’s Controlled Release Forms
Synchronizing and controlling API delivery, extrusion-spheronization (E-S) offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics.
WHITEPAPER - Launching a Drug-Device Combination: 5 Key Factors to Focus On
Going to market in a delivery device is one of the most complex steps in the life cycle of an injectable medication. A CDMO expert explains where to start and what to prepare for.
