Sponsored Podcasts

Poorly-soluble APIs present formulation and development challenges. Excipient selection and manufacturing process development are crucial. Continuous twin-screw granulation is gaining acceptance as a manufacturing technology to address issues presented by these APIs and is offering high production capacity in a small footprint. In this dedicated dialogue, solubility enhancement expert Andreas Gryczke from BASF will answer additional questions that have been posed in our recent webinar on Twin Screw Wet Granulation for Solubility Enhancement of Poorly Water-Soluble Drugs.

This podcast will feature the instructor of PDA’s new Education course, Establishment of a Risk-Based Environmental Monitoring Program, to be offered September 11, 2015 at PDA’s Training and Research Institute, located in Bethesda, MD. This course will present information on the establishment of a risk based environmental monitoring (EM) program, covering both the establishment of new EM programs as well as reassessment of current EM programs to ensure they are in compliance with industry standards. The goal is for participants to understand the tools available for conducting EM risk assessments and how to properly use them to create risk-based EM programs.

Cindy Dubin and Joe Kubicek, president and general manager of the Ansell Single Use Global Business Unit, discuss changes in how today’s pharmaceutical manufacturing and drug development companies approach their workers’ PPE and safety needs.   

Aerosols are used in several key areas within the pharmaceutical industry.  These include spray drying for the production of Active Pharmaceutical Ingredients, spray coating of APIs on tablets and stents, as well as nasal sprays and nebulizers as a preferred method of drug delivery.  In all these applications, the quality of the nozzles used in generating the aerosol spray is paramount to achieving the desired outcome.  This podcast discusses the major techniques for conducting a quality audit of spray nozzles and nebulizers.

When the clinical protocol dictates and/or helps with patient compliance, it can be necessary for investigational drug products to be packaged in blinded blister cards (wallets) that contain two, or more, different strength products. The presence of different products (placebo and/or active strengths) inside a packaging suite clearly raises the potential for error. So to combat this, a whole series of physical segregation and process controls are put in place to act as safeguards against product mix-ups.

Weiler Engineering, Inc.’s corporate focus is to provide advanced aseptic liquid processing technology through the application of customized ASEP-TECH® Blow/Fill/Seal machinery and services. Serving the pharmaceutical industry has been Weiler’s core business for more than 50 years. Weiler focuses on the patient and strives to provide the safest sterile aseptic packaging process for pharmaceutical liquids. This concept is based on studying and implementing learned technological advances driven by Science.

The podcast will showcase Vetter´s capabilities in its Chicago development service site. Additionally, it will inform about the completed site expansion with the addition of a third cleanroom. Clinical syringe projects are now being accepted at the facility.

This podcast will review BioSpectra?s interpretation of product suitability for intended end use. We will go over the meaning of product suitability as well as provide types of end use applications supported by BioSpectra?s products. Additionally, we will provide examples of BioSpectra?s offerings and key differences of these offerings based on intended end use.

Parenteral drug development is complex, costly, and subject to many levels of risk during the clinical phases. Only a few drug products ever make it to phase III, through approval, and on into commercial manufacturing. Given the numerous hurdles that exist, realizing the drug development process efficiently during all phases has become ever more important. And, having the right partner on board to support the project is critical in preparing a valuable drug package that can be used for either further product development and commercialization, or for a successful out-licensing deal.

Best Practices for Overcoming Softgel Coating Challenges

In this podcast, you will get an overview of hollow microneedle drug delivery and the importance that human factor research plays in the design and use of these devices.

Extractables and Leachables studies are an important part of the development cycle of any new drug product. It is important that an appropriate packaging system is chosen such that the product is stable and protected from degradation. It is equally important that this packaging system does not affect the purity of the product by leaching chemicals into the product. Rigorous extractables and leachables testing can ensure the proper packaging system is chosen, and an integral part of this testing regiment includes an extensive knowledge polymer chemistry.

Welcome to Pharmaceutical Technologies Podcast Series, "Do you really know your Relative humidity calibration vendor?" Our sponsor, Rotronic, is a technology leader in the field of relative humidity measurement. Rotronic operates company subsidiaries in The Americas, Europe, and Asia and is represented worldwide. Be sure to visit their web-site at www.rotronic-usa.com for further information.

Sartobind membrane adsorbers are an expedient and effective option for chromatographic removal of contaminants from a process feed stream. Built on a membrane of regenerated cellulose, Sartobind is available in strong anion and cation , hydrophobic interaction and salt tolerant anion exchange versions.

The practice of using inhaled substances to treat medical conditions has been around for millennia. It?s only in the last hundred years, though, that advancements in technology have allowed inhalation drug delivery systems to become an important delivery method for pharmaceuticals used by millions of patients worldwide. In this episode, Richard Beesley from 3M Drug Delivery Systems gives us an overview of the factors that have shaped inhalation drug delivery and considers how we may best equip ourselves to manage change in the future.