What is an Exhibitor Showcase?
Exhibitor Showcases are the platform for Pharma Professionals to present forward-thinking perspectives on their key products, innovations and services. These 25 minute free-to-attend presentations provide an open platform to interact face-to-face with developers.
Raif Kadri Dr. Valerie Desyroy, Vice-President of Sales Organic Chemist
Innovation Solution for Fixed-Bed Large-Scale Purification
Tuesday 10:30 - 10:55 AM
SiliCycle & Graver Technologies
SiliCycle and Graver Technologies will present a new technology developed specifically for rapid and reliable purification in flow format. Such unique product on the market addresses a growing and global interest in reducing the use of insoluble particulates in reactors. Available as cartridges of various SiliaMetS® Metal Scavengers or grades of activated carbon, metal removal will now be easily and quickly achieved from laboratory to industrial scale. This presentation will introduce metal scavenging results using this new technology along with the straightforward procedure to efficiently scale-up your processes. Download presentation slides.
Mark Cabell, Global Pharma Sales Manager, Thermo Fisher Scientific, Portable Analytical Instruments
Qualitative and Quantitative Material Analysis Using a Handheld Raman Spectrometer
Tuesday 11:00 - 11:25 AM
Thermo Fisher Scientific
Ensure the quality of materials from incoming raw material through finished product at the point of need with the Thermo Scientific™ TruScan™ RM handheld analyzer. Increase productivity and efficiency while minimizing lab sampling tests. The TruScan RM provides users with fast and accurate verification of a broad range of chemical compounds through sealed packaging. And now go beyond simple material ID with the Thermo Scientific™ TruTools™ chemometrics package. Build custom methods to deploy on the TruScan RM analyzer and use anywhere in the plant. Conduct quantitative material analysis and advanced qualitative analysis. Download presentation slides.
Oriol Prat, Director Contract Manufacturing Grifols Partnership
Reducing Risk During Preparation Admixtures
Tuesday 11:30 - 11:55 AM
There is a need for needle free valve bags to provide safe handling during preparation of admixtures in pharmacies. Pharmacists, nurses and physicians are particularly vulnerable to puncture and contamination during the process assuming health risk. Fleboflex® Luer is the latest step to offer you a polypropylene bag designed for the preparation, reconstitution and administration of medications without using needles. Download presentation slides.
Manuel Lourenco, Business Development Director
Manufacturing Solutions for the Health Care Industry
Tuesday 12:00 - 12:25 PM
Esteve Química has more than 50 years’ experience developing, manufacturing and marketing oral and injectable-non-sterile APIs (NCEs and generics) for regulated markets. Our cGMP’s multipurpose plants (two in Spain (EQ Esteve), one in Mexico (Sintenovo) and one in China (EHP)) have a total capacity of more than 800m3. Our services include process and analytical development, scale-up, analytical transfer, validation, process optimization and commercial manufacturing, along with any required technical services. In 2016, we have added Spray Drying and HAPI manufacturing capabilities. Please find out more about Esteve Química at www.estevequimica.com. Download presentation slides.
Dr. Andrew Thompson
J-STAR Research, Providing a Comprehensive Suite of Core Competencies to Ensure a Successful Supply of API in support of Preclinical and Phase I Development Programs
Tuesday 12:30 - 12:55 PM
J-STAR has become a world renowned leader in developing optimal synthetic processes supporting API needs for early preclinical and Phase I development programs. At the same time however, having a robust process supporting the synthesis of an API is only one of the critical pieces necessary to ensure a successful CMC program. Over the past number of years, J-STAR has expanded its offerings to also include a number of additional core competencies supporting API needs for early preclinical and Phase I clinical development programs. Additional areas of capabilities provided by the company include: cGMP Synthesis for Phase-I clinical supplies of API, Analytical Method Development and Validation, Stability Studies, Solid Form/Crystallization Screening, Crystallization R&D, Homogeneous Catalyst Screening, Impurity Isolation and ID (complete suite of 2D NMR techniques). By providing a comprehensive suite of capabilities supporting API needs, our clients can realize all of the needs for a clinical development program. Finally, in early April, J-STAR was acquired by Porton Fine Chemical, a world’s leader in the manufacturing of regulatory starting materials. So now, in addition to the comprehensive suite of core competencies as outlined above, the company can now provide an integrated solution supporting supply chain of regulatory starting materials supporting early development through to commercialization.
Dr. Katherine Bakeev, Director of Market and Customer Development
Raman to See Through Containers and Coatings
Tuesday 1:00 - 1:25 PM
Portable and handheld Raman systems with easy, intuitive operation are the tools of choice for raw material identification and research. The applicability of Raman is expanded with a new portable system featuring See_Through™ technology, which enables material identification inside visually opaque barriers such as white plastic bottles, paper envelopes, and coatings. The ST technology features a large sampling area and minimized power density, facilitating the measurement of heterogeneous materials and darker materials that would be susceptible to photo damage under conventional Raman spectroscopy. Download presentation slides.
Ramesh Subramanian, General Partner
What You Always Wanted To Know About Integrated Programs, but Were Afraid To Ask
Tuesday 1:30 - 1:55 PM
The growing number of clinical development projects coupled with cost rationalization initiatives, have led to a mismatch on internal resources that are required to manage drug substance and drug product sourcing needs at pharmaceutical firms. Increasingly, biotech and large pharmaceutical firms rely on global service providers that they can partner with for both their API and drug product needs. In this presentation, we describe Piramal’s approach towards integrated collaborations, our learnings, and our track record on executing integrated programs that include both drug substance/product and sites located in various geographies. Download presentation slides.
Rajiv (Bala) Balasubramaniam, Ph.D., Technical Director, Kodak Specialty Chemicals
Overview of Kodak Specialty Chemicals
Tuesday 2:00 - 2:25 PM
Kodak Specialty Chemicals is a Contract Manufacturing Organization (CMO), located in Rochester New York. Kodak’s multipurpose facilities have 88 reactor systems (100 to 1000 Gallons), Kilo labs and deep expertise in scale up and high quality manufacturing of complex molecules. Today, making over 500 distinct molecules, (ranging from a few kilograms to hundreds of tons), our data driven approach to process development and exceptional project management skills have been tested over decades of experience. Our dedicated project managers work with our customers to execute a fast paced scale up/tech transfer of custom molecules. Put our team and Kodak's extensive infrastructure within the Eastman Business Park to work for you! Download presentation slides.
Christopher McGee, Director, Business Development
Pioneering Partner for Peptides
Tuesday 2:30 - 2:55 PM
Bachem Americas Inc.
The presentation will overview the capabilities of the Bachem group, describe our typical approach to the development of peptide-APIs, and present our approach to partnering. Download presentation slides.
Dr. Yi Jiang, Business Director, Asia Emerging Business Development & Global Reactor Technologies
Innovation Drives Continuous-Flow Chemical Manufacturing
Tuesday 3:00 - 3:25 PM
Corning is a leading innovator in specialty glass, ceramics, and optical physics. Corning products have changed the world many times. We have done this by sustained investment in R&D for more than 160 years, and intense focus on solving tough and important problems.
In this talk, we will provide you our latest updates on Corning’s Advanced-Flow™ Reactor (AFR) innovation in term of new lab reactor system letting more people step into flow chemistry world, and upgraded commercial scale continuous-flow chemical production platform GP4 in Europe and Asia, as well as exciting pulls from China due to high demands on inherent safer manufacturing.
We will walk through our global operation map and priorities in EMEA, NA, and AP regions, and report the challenges and opportunities in promoting this technology, as well as share with what we have learnt.
Continuous Innovation and strategic partnership have played crucial roles in this arena.
Growing Confidence in Airless Dispensing
Tuesday 3:30 - 3:55 PM
Airless Dispensing Solutions from Aptar Pharma perfectly meet the requirements for the growing market for pharmaceutical semi-solid formulations for topical application.
Primary packaging attributes - like bulk protection, consumer convenience, and regulatory standards compliance - contribute greatly to the success of drug development and launch. Compared to bottles, tubes, or jars, Aptar Pharma’s Airless Dispensing Solutions successfully combine all these key attributes for semi-solid formulation dispensing.
Join Aptar Pharma’s presentation to learn more about the principles of Airless Dispensing Solutions and how our expertise can help with your drug development project. Download presentation slides.
Stephen Watt, CEO
Integrated Solid-State Screening and Crystallisation in the Development of Pharmaceuticals
Tuesday 4:00 - 4:25 PM
Solid Form Solutions
Dr. Haering, Cerbios-Pharma CEO
Cerbios HPAI Manufacturing: From 1993 Into the Future
Tuesday 4:30 - 4:55 PM
The presentation will cover the last 24 years of experience in the development and manufacturing of HPAI, (High Potency Active Ingredients), highlighting the capabilities and the latest investments in this fast growing area of Cerbios' exclusive manufacturing.
In addition, we will demonstrate the natural evolution of potent and super potent compound development and manufacturing by presenting the PROVEO ™ Integrated Services for ADCs, (Antibody Drug Conjugates), in which Cerbios is a partner, taking care of the Payload and Conjugation development and manufacturing in its Lugano production site. Download presentation slides.
Stefan Czvitkovich, PhD, Director PP Sterile Pharmaceuticals
Contract Manufacturing Services for Pre-filled Syringes – From Standard Solutions to Complex Products
Wednesday, 10:30 - 10:55 AM
Fresenius Kabi Product Partnering offers contract manufacturing services for sterile liquid injectable drugs from more than 20 manufacturing sites worldwide. Here, we introduce two of our FDA approved sites and their fill/finish capabilities for pre-filled syringes for third party manufacturing. The Fresenius Kabi sites in Wilson, NC and Graz, Austria can accompany our partners during process development and upscaling through to clinical and commercial batch manufacture. Our experience with different pre-filled syringe suppliers and scales enables us to offer drug product manufacture from standard solutions to complex formulations. Download presentation slides.
Gideon Schurder, Commercial Director, LGM Pharma
The Unfortunate Aftermath of the US-FDA Slamming API Factories
Wednesday, 11:00 - 11:25 AM
An in-depth look at the calamitous effects of recent FDA warning letters and import bans and how this affects the pharmaceutical industry; API manufacturers and formulation companies. Prime examples of how API factories should have acted to avoid getting themselves into hot water. How does all of this affect end patients and what the Trump administration can do in order to mitigate the outcome. Download presentation slides.
Gaurav Banerjee, Director of Technical Services and Enterprise Applications
Unrealized Effects of Implementing Serialization
Wednesday 11:30 - 11:55 AM
Sharp Packaging Solutions
As organizations work toward implementing serialization, many realizations inevitably occur – some of which are to be expected, and others not as obvious. In the CPHi NA presentation by Sharp Packaging Solutions, one company’s journey and learnings are presented to inform the audience of many of the changes to business process and infrastructure that take place in support of serializing products. The journey begins with obtaining and installing line level equipment and proceeds to describe the involvement of myriad supporting departments, in almost every business function to deliver serialization services. Download presentation slides.
Elisabeth Gortner, Marketing Manager
Lacamas Laboratories: Company Overview
Wednesday, 12:00 - 12:25 PM
Lacamas Laboratories is a CMO that has been in business for 30+ years with all manufacturing activities in Portland, Oregon, USA. The company has commercial and pilot manufacturing capabilities to produce custom molecules including advanced intermediates for API manufacturing. Lacamas Laboratories’ large scale manufacturing is focused on multi-metric ton quantities for commercial supply. The Process R&D laboratory and pilot plant can support requirements during clinical trials. Lacamas Laboratories is a reliable domestic source to support your project from development to commercialization. Download presentation slides.
Andrew Skinner, Director of Business Development
Overview of the Capabilities of FutureFuel Manufacturing Facility
Wednesday, 12:30 - 12:55 AM
Future Fuel Chemical Company
FutureFuel Chemical Company (FFCC) is a public company (NYSE:FF) which is 10 year young, but our plant has been in operation for 40 years. Starting in 1976 with chemicals for Kodak film, FFCC has history rich in complex organic synthesis. Our plant site is located on 2200 acres located near Batesville, AR. We have approximately 500 employees and we are non-union. We generate approximately $300M in revenue and manufacture products for agriculture, oilfield and automotive applications. Process hazard evaluation, scale-up, and analytical chemical are some of our many strengths. FFCC is a member of the American Chemistry Council and a Responsible Care site. Forbes magazine recently named FFCC one of the top 100 most trustworthy companies in America.
Doug Cochran, General Manager
Optima Chemical and Optima Belle Capabilities
Wednesday, 1:00 - 1:25 PM
Optima is focused on the core business of custom manufacturing and support services for advanced intermediates and fine chemicals to several industries including Pharmaceutical, Nutraceutical, Bioscience, Personal Care, and Food/Flavors. Additionally Optima Chemical offers a wide variety of Organometallic, Organophosphines, and Grignards to complement its established Boronic Acid product line. Download presentation slides.
Wednesday, 1:30 - 1:55 PM
Mr. Takumi Toida, Researcher, Mitsubishi Gas Chemical Company, Inc.
Multilayer Plastic Vial & Syringe with Glass-like Oxygen Barrier for Biologics
Wednesday, 2:00 - 2:25 PM
Mitsubishi Gas Chemical Company, Inc.
We are pleased to introduce multilayer plastic vial & syringe with glass-like oxygen barrier. Although glass is commonly used for parenteral packaging for many years, some disadvantages such as breakage, metal extractables, delamination, protein adsorption, etc. have been pointed out recently. As one of alternative materials, COP or COC is often applied to plastic vials and syringes but the oxygen barrier is much inferior to glass. To overcome every defect of current containers, we have developed OXYCAPT plastic vial and syringe consisting of 3 layers. Download presentation slides.
Giorgio Bertolini, Vice President R&D – Chemistry
Olon Acquisition of Infa Group: Much More Strength in CDMO
Wednesday, 2:30 - 2:55 PM
After the acquisition of Infa Group, Olon SpA has now a stronger position in the CDMO business offering integrated packages and services to support the full development of API based on Olon strong knowledge in both Chemical and Biological process all of them under a full cGMP and regulatory coverage combining specific and differentiating technologies coming from the two companies, for instance cryogenic reactions, photochemical conversions, hydride chemistry, organometallic reactions, cyanation, bromuration and fermentation technologies (Strain improvement and natural selection, Genetic engineering, Recombinant DNA technology with E.coli and yeasts strains). Download presentation slides.
Yadagiri Pendri Ph.D., CEO
Escientia Life Sciences – Discover, Develop, Deliver
Wednesday, 3:30 - 3:55 PM
Escientia located in South Windsor, Connecticut is a contract research, development and manufacturing organization serving Pharma and Biotech companies in the area of drug discovery, development and commercialization. Escientia’s team has synthesized novel molecules to support drug discovery chemistry and developed new routes for manufacturing safe, economical, and scalable processes of regulatory starting materials, advanced intermediates, and APIs. Our core strengths are in the areas of asymmetric synthesis, high-pressure reactions, flow chemistry, and handling fluorinations and high potency compounds. Escientia has well equipped R&D centers in Connecticut and Hyderabad and a state-of-the-art manufacturing plant staffed by experienced chemists for synthesis and analysis, chemical engineers for production and safety assessment, project managers, quality assurance, regulatory and EHS. Escientia keeps a strong focus on cost, speed, quality, safety, ethics, integrity and the ability to deliver significant value to collaborators by leveraging strong scientific and technical skills with global Pharma development experience.
Hebrert Hansen, Advisory Board
The Importance of Particle Size Reduction by Milling and Micronisation on Industrial Scale
Michał Radowski PhD, Technical Competence Center & B2B Pipeline Director
Polpharma B2B – a Central Europe One-Stop Shop” a brief introduction of Polpharma B2B services to the CPhI North America audience
4:00 PM Wednesday
Michał Radowski joined Polpharma Group in 2009 as R&D Project Manager in the API Division. Later he become the Head of the Pipeline and Project Management Department of Polpharma API Division. In 2013 he overtook the position of the Technical Competence Center & B2B Pipeline Director in a newly created Polpharma B2B Division. Michał has 10+ years of experience in the industry being additionally in the past the scientific officer and a co-founder of the Nanopartica GmbH. In addition Michal is a graduate of Chemistry Department of Gdansk Technical University (Poland) and earned his PhD in Nanotechology & Drug Delivery Systems from Freie Universität Berlin (Germany).
Anne Vogt, Ph.D., Account Director Custom Manufacturing, Evonik Health Care
Advantage of US Domestic API Manufacturing for Pharma and Biotech Companies
11:00 AM Thursday
Evonik Health Care
The United States represents the single largest market for pharmaceutical products in the world. Therefore, the demand for US domestic drug substance manufacturing capacities is expected to exhibit increasing strategic importance. In addition to regular potency APIs, high potency APIs represent a growing family of drug substances in the pipelines of pharma and biotech companies. The presentation provides an overview of Evonik’s US manufacturing services for GMP intermediates and APIs at its Tippecanoe Laboratories, Lafayette, IN, manufacturing site, which houses the world’s largest, non-captive HPAPI capacity in the CMO market.
Albemarle Fine Chemistry Services Custom Synthesis Capabilities
11:30 AM Thursday
Albemarle has been an industry leader in contract pharmaceutical, agrichemical, lubricant and specialty chemicals manufacturing for over 40 years. Our world-class facilities and advanced R&D capabilities enable our Fine Chemistry Services team to aid in every stage of product development – from laboratory through commercial-scale manufacturing. We have a GMP site (South Haven, MI) and a non-GMP site (Tyrone, PA). Our manufacturing services are backed by highly skilled R&D teams. Our group was selected as a winner in all six of the core categories of the 2017 CMO Leadership Awards.
Pharm. S. Aykut Adalmaz, International Trade Project Manager
Aiming for Healthy Futures by Creating Comfort
1:00 PM Thursday
Berko Pharmaceuticals Inc.
The presentation will be about how Berko aims for healthy futures by investing in innovation.