Agenda

All times displayed for Europe/Amsterdam timezone.

CPhI Theatre

Champagne taste for beer price? Metabolomic and isotopic fingerprint of commercial saw palmetto (Serenoa repens) extracts.
11:50 - 12:20 CPhI Theatre
Pharma Insight Briefings

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Saw palmetto (Serenoa repens, SP) is the most expensive oil source of the pharmaceutical and healthfood market, and its high cost and recurrent shortages have made its adulteration rampant. The most common adulteration of SP extracts is their replacement, or dilution, with cheaper food-based oils (canola, coconut, olive, palm, sunflower), a procedure easily detected by evaluating the fatty acids profile and the concentration of specific fatty acids relative to lauric acid, the major fatty acid (> 20%) of SP. On the other hand, the growing price of SP berries has spurred the development of novel and more sophisticated adulterations, like designer blends of fatty acids that mimic the phytochemical profile of SP and fraudulently comply with the current authentication assays of the oil. To detect this adulteration, isotopic fingerprint and -omic analysis have been comparatively applied, using Principal Component Analysis (PCA) to handle the complex databases generated by these techniques and to identify the possible source of the adulterants. The presence of fatty acids of animal origin turned out to be widespread in commercial samples of the plant.

Capsule based Dry Powder Inhalation – Opportunities, Trends & Solutions
12:30 - 13:00 CPhI Theatre
Pharma Insight Briefings
Scientific Business Development Manager – ACG Capsules
ACG Associated Capsules Pvt. Ltd

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Capsule based Dry Powder Inhalation – Opportunities, Trends & Solutions

Best practices for Highly Potent API (HPAPI) development & manufacturing
13:10 - 13:40 CPhI Theatre
Pharma Insight Briefings
senior Director, Head of Commercial Development for the Active Pharmaceutical Ingredient (API)
Lonza

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Drug product development for highly potent APIs (HPAPIs) can be challenging. Complications with the interface between operations in drug substance and drug product handling can result in increased program complexity and cost. This presentation focuses on best practices for developing and manufacturing highly potent compounds, contained particle engineering, and overall infrastructure requirements to meet accelerated timelines to clinic and market. Case studies which illustrate efficient and rapid development, scaling and commercial production of HPAPI will be discussed.

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13:50 - 14:20 CPhI Theatre
Pharma Insight Briefings

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14:30 - 15:00 CPhI Theatre
Pharma Insight Briefings

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15:10 - 15:50 CPhI Theatre
Pharma Insight Briefings

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Superba KrillTM oil supplementation improves skin hydration and elasticity in adults
15:50 - 16:20 CPhI Theatre
Pharma Insight Briefings
Director Research & Development
Aker Biomarine

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Polyunsaturated long-chain omega-3 fatty acids are vital to human health, yet average population levels are very low across several regions of the world. Superba KrillTM phospholipid omega-3s are a unique combination of docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and choline, and offers significant health benefits. Here we present preclinical data detailing skin incorporation of EPA and DHA as well as RCT data demonstrating improvements in skin hydration and elasticity following Superba KrillTM oil supplementation. Highlights • EPA and DHA are incorporated into skin following oral intake • Superba KrillTM oil improves skin elasticity • Superba KrillTM oil improves skin hydration

ICSE Theatre

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11:50 - 12:20 ICSE Theatre
Pharma Insight Briefings

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12:30 - 13:00 ICSE Theatre
Pharma Insight Briefings

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TBC
13:10 - 13:40 ICSE Theatre
Pharma Insight Briefings
Vice President, Contract Manufacturing, Pfizer Global Supply and Pfizer CentreOne
Pfizer

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ALCOA data integrity assessment
13:50 - 14:20 ICSE Theatre
Pharma Insight Briefings
Vice President Business Development
PQE

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ALCOA data integrity assessment: ALCOA data integrity assessment is a fundamental tool for successful regulatory and customer inspections.

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14:30 - 16:00 ICSE Theatre
Pharma Insight Briefings

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15:10 - 15:40 ICSE Theatre
Pharma Insight Briefings

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Managing the Pharmaceutical Supply Chain
15:50 - 16:20 ICSE Theatre
Pharma Insight Briefings
Executive Director, pharma biotech
NSF International

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Pharmaceutical supply chains within the pharmaceutical industry have become very complicated with many actors. In these increasingly complex supply chains, how can you identify and manage risks?. This presentation will cover: How to meet the EU regulatory how can you identify and manage risks?. This presentation will cover: How to meet the EU regulatory requirements for API supply chains - What needs to be included in the QP declaration - How you can use recent legislation to identify and manage risks - The potential impact of BREXIT on supply chains.

Accessing the European Market
16:30 - 17:00 ICSE Theatre
Pharma Insight Briefings
Pharmaceutical Scientific Advisory Director
Azierta

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Pharmaceutical supply chains within the pharmaceutical industry have become very complicated with many actors. In these increasingly complex supply chains, how can you identify and manage risks?. This presentation will cover: How to meet the EU regulatory requirements for API supply chains - What needs to be included in the QP declaration - How you can use recent legislation to identify and manage risks - The potential impact of BREXIT on supply chains.

Innopack & P-MEC Theatre

Antimicrobial protection by the matter’s power : application to the pharmaceutical products to replace preservatives and better protect the patients
11:50 - 12:20 Innopack & P-MEC Theatre
Pharma Insight Briefings

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Pharmaceutical products containing an aqueous phase are susceptible to microbial contamination during use and require the addition of preservatives to limit the proliferation of pathogenic micro-organisms. However, some preservatives are allergens, irritants and/or suspected of being endocrine disruptors and cancer-causing agents in humans. Pylote develops, produces and markets innovative technology based on an exclusive manufacturing process for 100% mineral microspheres that transfer microbial properties to the materials into which they are integrated. Pylote technology has a significant impact on a wide variety of microorganisms, including bacteria expressing acquired antibiotic resistance, and viruses. Given that microspheres are listed as authorized additives in international Pharmacopoeas, do not contain nanoparticles and there is no migration from the host material, the technology is totally safe for consumers. Microspheres have been integrated successfully on the industrial production lines of many products such as eye-droppers, liquidsticks, wipes, cosmetic dispensers and applicators, without altering the manufacturing process. Pylote reduces the source
of microbial contamination during use in order to reduce or remove the use of preservatives while guaranteeing a “microbiologically clean” dosage to consumers.

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12:30 - 13:00 Innopack & P-MEC Theatre
Pharma Insight Briefings

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Evolution of Raman into Preferred Method for Pharma QA/QC Analysis
12:30 - 13:00 Innopack & P-MEC Theatre
Pharma Insight Briefings
Business Development
B&W Tek

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Raman technology has evolved quickly over the past 10 years, going from novel lab-based technology to easy-to-use, on-the-spot handheld and portable analyzers that fulfill specific purposes. Handheld Raman is now considered one of the best choices for incoming raw material identification, allowing users to scan through secondary packaging and get results within seconds. Raman is also seeing uptake in pharmaceutical R&D and QC labs, with portable Raman being used for content and blend uniformity as well as in formulation development. During this seminar, Dr. Enrique Lozano Diz will describe several applications and how quality testing with Raman can save companies time and give great returns on investment.

Modern approaches to Pharma QC
13:10 - 13:50 Innopack & P-MEC Theatre
Pharma Insight Briefings
Pharma Marketing Manager
Agilent

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This seminar will describe the application of Raman and Infrared Spectroscopy for Quality Control in Pharma. This will include use of Raman for raw materials verification of incoming goods through unopened non-transparent Containers and the use of transmission Raman as an alternative to UPHPLC for content uniformity studies. Furthermore, use of a next generation IR instrument using a quantum cascade laser will be described for chemical imaging studies including analysis of tablet component distribution, polymorph distribution, salt exchange and stability studies.

Building a Connected Devices Eco-System for Digital Medicines
13:50 - 14:20 Innopack & P-MEC Theatre
Pharma Insight Briefings
Business Development Director for Connected Devices
Aptar Pharma

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At this Pharma Insight Briefing session, Sai Shankar, Director Business Development Connected Devices will discuss Aptar Pharma’s approach to building the Digital Medicine ecosystem for connected drug delivery devices across therapeutic areas. To deliver on the promise of digital medicine to improve patient outcomes, it is important to look at the building blocks of such an eco-system. This starts with understanding the challenges faced by patients while taking their medications, their interactions with the drug delivery systems and how design of connected devices can be seamlessly integrated to improve adherence. This patient-centric design approach will determine the type of data that should be generated from the connected devices, which in turn will drive the type of technology that should be adopted. These design decisions will also impact the electronics design architecture, stacking of different technology options and cross-platform interoperability. Complementing the device design should be a proven high quality manufacturing setup that has a secure supply chain for electronics and plastic components. The last mile of building the ecosystem is the successful pairing of the data from devices to the digital medicine platform.

Container Closure Integrity Testing of Sterile Pharmaceutical Product
14:30 - 15:00 Innopack & P-MEC Theatre
Pharma Insight Briefings

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The recently release draft Annex 1 Revision could result in significant changes to the requirements for container closure integrity (CCI) testing. In addition, FDA requirements for CCI testing are being influenced by the recently revised U.S. Pharmacopeia <1207> chapter on 'Package Integrity Evaluation - Sterile Products'. This presentation will discuss the proposed regulatory changes and present case study examples for industry best practices for CCI testing during the product life cycle. Examples include statistical CCI studies, validation of raised stopper limits, validation of CCI during transport, and CCI testing during shelf life.

Moulding the future? How moulded glass is supporting biotechs and OTC
15:10 - 15:40 Innopack & P-MEC Theatre
Pharma Insight Briefings
Managing Director
VAL-U Advisory
Public Affairs Manager
FEVE
Chief Commercial Officer
SGD Pharma

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The biopharmaceutical is a very important growing market – key insights on the characteristics of this market, the challenges it represents, and expectations customers have from the packaging supply chain will be outlined. OTC is not a new market and glass is already very much present in this sector. However, customers decision-making on packaging is more than often driven by other aspects than the product preservation and the total absence of interaction with the contained product. In this segment there is a need to redefine the role of molded glass as premium packaging material at very competitive market conditions. The glass industry is investing in both segments as major drivers for innovation of the packaging solutions, and for a redefinition of the industry business model from a glass container manufacturer to a value-added and high-quality solutions provider. This will add to the unique inherent properties of glass in terms of inertness and recyclability. How can glass flaconnage industry strengthen its position of key partner for the pharma industry? Is there space for more and better collaboration between the glass supplier and the pharma customer?

Tracking on primary packaging with anti-counterfeiting feature
15:50 - 16:30 Innopack & P-MEC Theatre
Pharma Insight Briefings
CSO Pharma & Medical
Stoelzle-Oberglas GmbH

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Tracking and Tracing is more and more important to all of us. We do want to know where, when, and who has produced the goods to chain back the distribution in the case of an information lack or any issue. Also with the Stölze solution " Track-back to the beginning of glass" we support on the primary packaging the requested information for logistic, quality and even for marketing.

Gx RTF ClearJect - a COP syringe made in Germany
16:30 - 17:00 Innopack & P-MEC Theatre
Pharma Insight Briefings
Manager Technical Support Medical Systems
Gerresheimer

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Besides the traditional glass syringe, polymer syringes have established in the aesthetics as well as in the biotech and animal health sectors. There are some advantages of polymer syringes, especially high break resistance and freedom of design, as they are not produced from tubes like glass syringes. Especially for highly demanding drug formulations the features "glue free" and "tungsten free" are important. Particulate matter caused by the siliconization of the syringes are often an issue for sensitive drug formulations. Low particle loads are achieved by a special siliconization and there are silicone free options feasable. The presentation will give an insight into the new production facility for COP syringes called "Gx RTF Clearject" in Germany.

Workshop Theater

Production of chemical specialties in the Czech Republic
13:20 - 13:40 Workshop Theater
Pharma Insight Workshops

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