PharmTech Podcasts

2016 PDA Universe of Pre-filled Syringes & Injection Devices
This podcast will feature the two members of the Program Planning Committee overseeing the 2016 PDA Universe of Pre-filled Syringes & Injection Devices, taking place October 17-18, 2016 in Huntington Beach, CA. The speakers will be discussing some of the key issues to be addressed at the Conference.

 


Decontamination and Depyrogenation of an ASEP-TECH® Blow/Fill/Seal System
Weiler Engineering has teamed up With Noxilizer to be the first to offer the market with an NO2 Gas sterilization method for effectively Decontaminating, sterilization and Dehydrogenating the Inside of the Class 100 filing zone. During testing cycle parameters were varied to determine the optimum process efficiency; these parameters included Humidity, NO2 concentration and exposure time. For each exposure cycle, there were nine biological indicators and four endotoxin vials for the demonstration of decontamination and depyrogenation. The BI’s and endotoxin vials were widely distributed during testing. The BI results demonstrated complete decontamination, with a consistency 6 log reduction of viable spores. The endotoxin results demonstrated a more than 3 log reduction in endotoxin units. These tests utilizing NO2 demonstrate that the ASEP-TECH Blow/Fill/Seal system can be decontaminated and depyrogenated.


Road to Global Serialization
With the increase in the drug counterfeiting across the world, many countries along with the Global Standards body (GS1) have come up with various country regulations which can keep counterfeiting at bay. With Serialization and new traceability requirements in many countries, the life sciences industry is undergoing a paradigm shift in the way it labels and transacts sales of prescription drugs and biologic products.


PDA 11th Annual Global Conference on Pharmaceutical Microbiology
This podcast will feature the two members of the Program Planning Committee overseeing the PDA 11th Annual Global Conference on Pharmaceutical Microbiology, taking place October 24-36 in Arlington, VA. The speakers will be discussing some of the key issues to be addressed at the Conference.


Outsourcing Pharmaceutical Manufacturing: Keys to Successful Technology
Today’s pharmaceutical pipeline requires more flexibility in manufacturing than ever before. Fast, reliable product launches are critical, and a wide range of product and network strategies are needed to support demand for tailored manufacturing solutions. In this episode, we will discuss the roadmap for successful technology transfers and important factors to be taken into account when choosing the right partner.


Secure Document Workflows in Drug Development

Intensified regulatory scrutiny of data and reporting has increased demand for authentication of documents used in bio/pharma development and manufacturing. Mollie Shields Uehling, CEO of SAFE-BioPharma an association working to provide high-assurance identity trust for cyber transactions, describes the role digital signatures can play in ensuring the integrity of documents used in drug development and manufacturing processes.The discussion includes applications for digital signatures in pharma research, development, and manufacturing; regulatory requirements for document authentication; and how digital signatures can improve document authentication and workflow within organizations and when collaborating with external partners. 



Zydis® - The Versatile Orodispersable Tablet (ODT) Technology
Orally disintegrating tablets are well known for their advantages in terms of patient compliance and convenience.  However, as a freeze dried product, the Zydis® ODT platform offers additional benefits including sublingual delivery of conventional small molecules to avoid first past metabolism and improve bioavailability, stabilization of API nano-particles for improved oral bioavailability of BCS class II & IV compound, potential for sublingual delivery of peptides and vaccine antigens.


A Decade of CordenPharma
Since inception in 2006 as a pharmaceutical brand of International Chemical Investors Group (ICIG), CordenPharma has grown over the last decade into a Full-Service CDMO with broad capabilities for the supply of APIs, Drug Products and associated packaging services to the global pharmaceutical market. We will discuss its strategy for growth, changes, challenges and trends in the CMO industry and where CordenPharma is headed in the next 10 years.


Oral Dose Development for Macromolecules
Today, a majority of macromolecule doses are delivered in traditional but invasive injectable formats, which often results in poor patient compliance and therefore is not the most suitable route for long term treatment. Although oral delivery has always been preferred, there are a variety of development challenges faced by formulation scientists. In this episode, we will discuss a new approach OptiForm® Solution Suite Bio, introduced by Catalent, to optimize oral dose development for macromolecules.


Industry Perspectives
Robert DeWit, PhD, DABT, recently joined MPI Research as the Company’s president. During this interview Dr. DeWit will share his insights on industry trends, outsourcing opportunities, and the future of drug development.


What to Look for in a Solubility Enhancement Vendor
Pharmaceutical Technology will be interviewing Kaspar van den Dries, Sr. Director Solid Dosage Development at Patheon regarding what customers should consider when looking for a solubility enhancement vendor. Kaspar will discuss critical areas to evaluate, including technology experience, scientific expertise, problem solving culture, speed to clinic and approaches to addressing low solubility challenges. 


Vitamin E TPGS for drug delivery innovation
Vitamin E TPGS is an attractive excipient for innovative drug delivery solution. TPGS is natural Vitamin E derivative, non-ionic surfactant, an attractive tool for solubility improvement, for stabilization of micro emulsions and for building nanoparticles in drug formulation. ISOCHEM is a key producer/supplier of Vitamin E TPGS offering top level service by delivering cGMP product from research quantities to multi-tons for commercial phase.


The Importance of a Project Manager with Outsourcing
When outsourcing, there are many factors to consider when choosing a Contract Manufacturing Organization (CMO) partner. In this podcast, Regis Technologies' Lead Project Manager, Rebecca Centko, discusses the importance of choosing a CMO that provides a dedicated Project Manager. She discusses how a Project Manager is the customer's advocate and voice within the CMO's internal groups, and she provides tips on how to work with a Project Manager starting during the proposal process to ensure a successful outcome for timeline, budget, and quality.


Advantages of Continuous Manufacturing
Batch processing is a trusted approach has been used for decades in the pharmaceutical industry. However, other industries that produce and process materials are steadily moving to continuous manufacturing, driven mainly by cost and quality considerations. Pharmaceutical Technology magazine recently spoke with Dr. Eric Jayjock, Director of Continuous Manufacturing at Patheon, about the company’s approach to building a continuous manufacturing framework.


Taking a More Informed Approach to Solubility Enhancement
A comprehensive solubilization strategy must include a comprehensive understanding of the drug molecule and the target product profile. Only then can a solubilization-enhancing technology be selected. Pharmaceutical Technology magazine recently spoke with Marshall Crew, Vice President, PDS Global Science, at Patheon, about how this approach enables formulation scientists to know the starting point and direction of the process from the earliest stage to formulation design and optimization.


 

Twin Screw Wet Granulation for Solubility Enhancement of Poorly Water-Soluble Drugs
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.


Healing the World with Surgical Precision
MPI Research understands the value of precise, high-quality discovery and preclinical skills. During this event the audience will learn about wound healing models, lessons learned, and industry trends.


The Role of Semisolid Microstructure in Topical Formulation Performance and Functionality
BASF explains how the selection of excipients in topical semisolid formulations can de- termine the structure of microscopic phases that form during processing.Pharmaceutical Technology magazine recently spoke with Dr. Bozena Michniak-Kohn, Pro- fessor and Director of Center for Dermal Research at Rutgers University, and Norman Rich- ardson, Global Technical Development and Marketing Manager, Skin Delivery at BASF, about the importance of semisolid microstructure and the impact they have on the final formulation.


Considerations in the Development of Controlled Release Formulations
Developing a controlled  release formulation of a new chemical entity (NCE) is more and more becoming the standard practice for innovator pharmaceutical companies. The typical rationale for developing a controlled release product is to provide better therapeutic benefits and minimize side effects. In addition to the therapeutic advantages, a controlled release formulation provides a route for additional patent protection and the extension of a product's life cycle. It is important to understand what NCE  characteristics need to be considered when developing a controlled release drug product, and what criteria to evaluate to help decide what is the best technology for formulating a particular compound.  The extra time and resources it may take to develop a product using a Quality by Design approach is well worth it.  Also, creating an in vivo/in vitro correlation can speed up the regulatory approval process.


Binding of Peroxide Sensitive API Podcast
Excipients are crucial for effective drug formulation, and excipient manufacturers continue to make advances in technology designed to address the formulation challenges presented by new drug substances. Pharmaceutical Technology magazine talked with Dr. Bernhard Fussnegger, Global Development and Technical Marketing at BASF, about the excipient developer’s family of peroxide-free excipients that are recommended for APIs sensitive to oxidation.


PDA Education Course: Establishment of a Risk Based Environmental Monitoring Program
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.


PDA 10th Annual Global Conference on Pharmaceutical Microbiology

This podcast will feature the two members of the Program Planning Committee overseeing the PDA 10th Annual Global Conference on Microbiology, taking place October 19-21 in Bethesda, MD. The speakers will be discussing some of the key issues to be addressed at the Conference, which is also celebrating its milestone 10th Anniversary.


Smart Supply Chain Management: Managing Complexity
Senior Editor Agnes Shanley reviews key points pharma companies should address to meet global requirements for pharma supply chain safety. Hear how pharma companies can address the concerns such as drug counterfeiting, adulteration, and drug shortages.


Trends in Hand & Product Protection
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.


Spray Characterization for the Pharmaceutical Industry
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.


Clinical Blinded Blister Cards- How to Create Multi-Fill Blister Cards Using Product Placement Shields© and UV Reactive Inks
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.


Advanced Aseptic Liquid Processing Technology
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.


Vetter Development Service Chicago: New manufacturing options tailored to your drug product needs
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.


Product Suitability for Intended End Use
A podcast reviewing 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.


Explore state-of-the-art clinical filling in Chicago
The podcast will showcase Vetter's service portfolio as a company in general, and its offering in the development service area in detail. In addition, this podcast will focus on the companies` capabilities in its Chicago development service site, including its customer base. An informative case study highlighting the critical expertise needed in today's drug development environment will be presented.


Best Practices for Overcoming Softgel Coating Challenges
A webinar, Best Practices for Overcoming Softgel Coating Challenges, sponsored by BASF and Pharmaceutical Technology magazine, describes advantages of the drug dosage form, solubility issues, and fill selection criteria for moisture regulation and gelatin compatibility. Rita Peters, editorial director of PharmTech, joins Kai Zhuang, Senior Technical Sales Representative, BASF, to share some key points from the presentation.


Patient-centric Considerations for Intradermal Delivery via Hollow Microneedles
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.


The Rheology of Pharmaceutical Products
Physical tests for rheological behavior are performed by R&D scientists who qualify new formulations for processability in manufacturing and acceptability to customers when consumed. Rheology is the science of flow behavior and applies to a broad range of materials, ranging across powders, liquids, soft solids (E.g. ointments), and solids (E.g. tablets, hard shell capsules). Instruments used to conduct these tests include viscometers, rheometers, texture analyzers, and powder flow testers. QC has responsibility to implement “short” versions of these tests to verify that product with consistently acceptable quality is manufactured on a daily basis.


Influence of Gut Microbiota on Drug Metabolism
Drug metabolism is a central area of research for effective drug design and therapy. What has been well explored is the metabolism of drugs after they enter the body following oral absorption. The main organ for systemic metabolism of drugs is the liver which metabolizes drugs into more hydrophilic metabolites to be excreted mainly with the urine. Other drugs and their metabolites may be excreted with the feces or via other pathways. However, what has just recently gained interest is the presystemic metabolism of drugs by bacteria in the intestinal tract. Since nearly 85% of all drugs on the market are given via the oral route, consideration of what happens to the drug after it is released from its dosage form is an important part of providing patients with the best possible therapy depending on their condition and health status. This podcast will explore the various influences that the gut microbiome may have on the metabolism of drugs. This in turn may influence the way drugs are designed and formulated to achieve the best therapeutic outcome for patients.


The Importance of Possessing Good Polymer Chemistry Knowledge in Conducting Extractables/Leachables Studies
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. Davie Love answers a few short questions to help you better understand the capabilities of your vendor.


Do you really know your relative humidity calibration vendor?
There are so many ways to incorrectly calibrate a relative humidity sensor that it is important to closely look at the capabilities of your calibration vendor. ISO17025 accreditation is a very good place to start, but not all ISO17025 calibration labs are equal. David Love answers a few short questions to help you better understand the capabilities of your vendor.


Realizing Opportunities in Caregiver-intensive Settings through Transdermal Drug Delivery
In this episode, Dr. Kirsty Gapp, Transdermal Drug Delivery Platform Business Manager, EMEA, at 3M Drug Delivery Systems discusses how an aging global population and the need for continual innovation in the pharmaceutical industry factor into drug delivery systems that move beyond traditional pills and capsules into transdermal drug delivery.


Sartobind Membrane Adsorbers
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.


Inhalation Drug Delivery
The practice of using inhaled substances to treat medical conditions has been around for millennia. Only in the last hundred years, though, have 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 interview, Richard Beesley from 3M Drug Delivery Systems provides 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.


Basic Training: Glycan Analysis
In the Basic Training series, experts from the National Institute for Bioprocess Research and Training (NIBRT) provide in-depth looks at key bioprocessing steps. Here, Pauline Rudd discusses glycan analysis.


Establishing a Culture of Compliance
Ron Johnson, President of Becker & Associates Consulting, an NSF International Company, discusses the critical need for establishing a “culture of compliance” for companies seeking to prevent, or remediate, regulatory compliance violations. An organization’s culture is shaped by its values, principles and beliefs. These are established at the top of the organization and must be effectively communicated throughout the enterprise. Training of employees and management is one of several critical elements to the establishment of a culture of quality.

 

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