CPhI Speaker's Corner 2013
CPhI Speaker's Corner Schedule 22-24 October
Tuesday, 22 October
Presentation of innovation award nominees
|10.00 – 10.20||API Corporation||A novel and practical synthesis of highly functionalized pharmaceuticals through C-H activation|
|10.30 – 10.50||Bachem||Pioneering breakthrough in the chemical synthesis of Interferon β-1a||José de Chastonay, PhD|
|11.00 – 11.20||Codexis||Enzymes for Green and Scalable Biocatalytic Oxidations||Jim Lalonde|
|11.30 – 11.50||Bitop||Ectoin® - a new natural ingredient with proven efficacy||Dr. Silke Behne|
|12.00 – 12.20||Camurus||FluidCrystal® Injection depot||Dr. Fredrick Lindström|
|12.30 – 12.50||EmulTech||Microfluidic platform for controled development||Fränk de Jong|
|13.00 - 13.25||PHARMCO-AAPER||New USP 232 and ICH-Q3D Heavy Metal Mandates! Inside the mind of the FDA – what is their ultimate agenda for the impending USP 232 and ICH-Q3D heavy metal mandates? Find out the potential impact on API and final drug manufacturing for years to come and how PHARMCO-AAPER products meet these requirements today!||Paul DiMarco|
|13.30 - 13.55||Dow Corning||Improving efficacy and compliance: Innovative silicone-based topical and transdermal drug delivery systems||Myriam Delvaux|
|14.00 - 14.25||Bachem AG||Synthetic Manufacturing of Glucagon (1-29)||Thomas Meier|
|14.30 - 14.55||Thomson Reuters||For Companies Nearing the Patent Cliff- are Biosimilars the Parachute?||Ludivine Pennaneach|
|15.00 - 15.25||Continuous Manufacturing and Crystallisation (SDI)||Collaboration, Crystallisation and Continuous Conundrums||Craig Johnston|
|16.00 - 16.25||Novozymes Biopharma UK Ltd.||An introduction to Enzymes for Biocatalysis|
|16.30 - 16.55||SAFC||What is the Future for Western CMO's||Andreas Weiler|
Wednesday, 23 October
|10.00 - 10.25||Aptalis||Partnering with Aptalis Pharmaceutical Technologies for Patient-Optimized Products||Nadine Maalouf, Pharm. D.|
|10.30 - 10.55||SPI Pharma||Actimask® 92S, a Novel, Aqueous-Coated, Taste-Masked Ibuprofen for Direct Compression||John K. Tillotson, PhD, R.Ph.|
|11.00 - 11.25||Heraeus Holding||Heraeus – your partner for cytotoxics, payloads and conjugation||Dr Friedrich Wissmann|
|11.30 - 11.55||Rockwood Lithium (Chemetall GmbH)||Complex Metal Hydrides for Selective Reductions||Dr. Christoph Krinninger|
|12.00 - 12.25||Rockwood Lithium (Chemetall GmbH)||New Organometallic Tools for Organic Synthesis||Dr. Armin Stoll|
|12.30 - 12.55||Procaps||Unigel™ Case Study: Extending Soft Gelatin Capsule Benefits to Novel Fixed Dose Combinations||Diego Monterroza|
|13.00 - 13.25||Thermo Scientific Portable Analytical Instruments||Material Identity/Verification with Thermo Scientific Handheld Spectrometers||Shailesh Karavadra|
|13.30 - 13.55||Winclove Probotics Amsterdam||What can probiotics do in health? Ecologic®: clinically proven designer multispecies probiotics||Catherina (Karen) Koning|
|14.00 - 14.25||CABB||Sustainable manufacturing: Outsourcing at CABB||Dr. Jörg Schrickel|
|14.30 - 14.55||LGC Standards||Reference standards: root cause of many FDA 483 observations||Dr Christian Zeine|
|15.30 - 15.55||Dow Europe||Novel Cellulosic Materials for use in Bioavailability Enhancement||Dr. Amina Faham|
|16.00 - 16.25||The Purolite Company||Industrial immobilized enzymes: processes, economics and key applications||Dr. Alessandra Basso|
Thursday, 24 October
|11.00 - 11.25||Avantor Performance Materials B.V.||Controlling Biopharmaceutical Process and Product Variability||Mr. W.Hesselink|
| Aptalis |
| Nadine Maalouf, Pharm. D., Associate Director, Licensing, Pharmaceutical Technologies |
| Weds 23 October 10.00 - 10.25 |
| Partnering with Aptalis Pharmaceutical Technologies for Patient-Optimized Products |
Patient-centric products available in oral dosage forms have great utility and appeal to a range of target patient populations. Partnering with a drug delivery company that has a demonstrated expertise in novel product formulations and the ability to address compounds with difficult delivery characteristics can improve the market value of your product.
| Avantor Performance Materials B.V. |
| Mr. W.Hesselink, Application Project Manager |
| Thursday 24 October 11.00 - 11.25 |
| Controlling Biopharmaceutical Process and Product Variability |
In biopharmaceutical production, the manufacturing process determines the quality of the end product. A typical manufacturing process begins with an upstream development process with cell culture or fermentation, followed by a downstream purification process that includes fill and finish and, finally, formulation of the drug product. Each step has different critical aspects related to raw materials, where a change in a raw material composition could immediately impact product or process consistency.
This presentation will discuss the manufacturing strategy of critical raw materials and demonstrate how controlling variability and consistency can lead to consistent process or products. The accompanying paper will present examples where raw materials have impacted end products along with ways to control variability.
| Bachem AG |
| Thomas Meier, Vice President Production Bachem AG |
| Tues 22 October 14.00 - 14.25 |
| Synthetic Manufacturing of Glucagon (1-29) |
| Glucagon is a linear peptide of 29 amino acids. It is approved as therapeutic in all major pharmaceutical markets. Bachem manufactures this peptide drug substance by chemical synthesis for a regulated market. The presentation will cover the upstream and downstream process and include consideration concerning the DS release testing. In addition it will comprises the test methods that are applied at Bachem to understand aggregation propensity and what measure were successfully employed to optimize the solubility behavior of synthetic peptide DS' with strong tendencies to form fibrils. |
Bachem is an independent, technology-based, public biochemicals company
providing full service to the pharma and biotech industry. Bachem is specialized in
the process development and the manufacturing of peptides and complex organic
molecules as active pharmaceutical ingredients (APIs), as well as innovative
| Mr. A.W. Willemse, CEO |
| Weds 23 October 14:00 – 14:25 |
| How a CMO can help your product development |
|BioConnection is a Dutch contract services and manufacturing organization for the development and production of injectable (bio)pharmaceutical products. We have the means and expertise to bring your invention from the lab to the clinic and/or to the market. Due to our unique setup and best-in-class European network of development and manufacturing partners we are able to provide you with tailor made solutions with unmatched flexibility. Our approach ensures a seamless development and manufacturing chain for your product. We have access to various GMP manufacturing facilities across Europe that are all in compliance with the EMA and/or the US-FDA guidelines. The cornerstones of our CMC services are: Drug Product development (formulation, analytics, freeze-dry cycle), fill & finish and freeze-drying at clinical and commercial scale. We are currently expanding our capabilities with the development and GMP manufacturing of complex formulations such as microspheres, liposomes and nanoparticles. In this network Sinensis Lifesciences is an important player delivering QC-Analysis, microbiology, GMP manufacturing and analytical development services. During our presentation both BioConnection and Sinensis LifeSciences will present their capabilities to contribute to your successful project.|
| CABB |
| Dr. Jörg Schrickel, Manager New Business Development |
| Weds 23 October 14.00 - 14.25 |
| Sustainable manufacturing: Outsourcing at CABB |
| The responsible use of raw materials and energies is important for a sustainable synthesis of chemical intermediates. Atom efficient processes, the reduction of waste and the safety of manufacturing processes are further important characteristics of green chemistry. |
Especially the pharmaceutical synthesis of active ingredients is an energy and resource demanding process. Many production processes are not optimised yet and can be improved regarding atom efficiency, formation of waste, use of solvents, or reduction of the energy needed.
CABB operates a Verbund and recycling system which represents a vertically integrated production system especially for chlorination and sulfonation reactions. This allows to perform chlorination and sulfonation reactions in the most efficient and sustainable way and significantly helps to reduce or prevent the formation of waste. In addition, a safe handling of hazardous reagents can be secured by a sophisticated infrastructure.
The presentation will show comprehensible examples of how these chemical reactions can support sustainable manufacturing and includes case studies of efficient and sustainable chlorination and sulfonation reactions and of continuous processes.
| CMAC - Continuous Manufacturing and Crystallisation |
| Craig Johnston, CMAC Operations Director |
| Tues 22 October 15:00 - 15:25 |
| Collaboration, Crystallisation and Continuous Conundrums |
| CMAC is a world leading industry / academic membership consortium. Industry led, its aim is to accelerate the adoption of more productive continuous processes for high value products, especially pharmaceuticals. GSK, Novartis and Astrazeneca are founding tier 1 members, with technology companies also playing an important role. The physical hub is at Strathclyde University with Glasgow, Heriot-Watt, Edinburgh, Cambridge, Loughborough and Bath Universities contributing to an exceptional multi-disciplinary academic team. |
More than £60m has been raised from various sources. The key research platform is the EPRSC National Centre for Innovative Manufacturing in Continuous Manufacturing and Crystallisation led by Prof Alastair Florence. Achieving this aim will enable quicker, more cost effective product development and cheaper, cleaner and greener manufacturing processes.
| Dow Corning |
| Myriam Delvaux, Global Market Leader – Drug Delivery Systems |
| Tues 22 October 13.30 - 13.55 |
| Improving efficacy and compliance: Innovative silicone-based topical and transdermal drug delivery systems |
Increasing costs of health care are driving payers to demand outcome-based solutions - increasing the need for improved efficacy and patient compliance in the delivery of pharmaceuticals. The materials you choose in your drug delivery systems can have a significant impact on both, especially in non-oral delivery forms, such as transdermal patches and topically applied pharmaceuticals.
As a transdermal system designer, you need adhesion, but also stable, optimized drug loading, delivering a controlled amount of drug over a defined time period. As a formulator of a topically applied API, you also need to make sure the patient is effectively treated with new and appealing forms that are non-oily, non-greasy and easy to apply.
Silicones have a proven history to effectively load, stabilize and release actives from a variety of matrices. As a world leader in silicone technology, we will explain how our new developments can help you address your key drug delivery challenges and how Dow Corning is advancing healthcare through material innovations. Please listen to our lecture and then visit us at booth 31 B06 to learn more.
| Dow Healthcare & Medical |
| Dr. Amina Faham, Senior Pharmaceutical Development Application Manager |
| Wed 23 October 15:30 – 15:55 |
| Novel Cellulosic Materials for use in Bioavailability Enhancement |
One of the current big challenges in the pharma industry is solubilisation of a pipeline of poorly water soluble drugs. The Active Pharmaceutical Ingredient (API) cannot reach its molecular target if the drug is not dissolved in the gastro-intestinal tract (GIT). Therefore, formulation scientists are increasingly in need of reliable and robust technology solutions to overcome this critical drug delivery issue.
The presentation will talk about AFFINISOL™ HPMC-AS offering. Dow is allowing formulators to optimize API performance via substitution levels, utilizing QbD principles. Model compound screening indicates QbD is critical to ensure robust formulations. Low viscosity AFFINISOL™ HPMC-AS is a new product, tailored to enhance spray drying efficiency. As we continually innovate, Dow is also working on AFFINISOL™ HPMC which will bring the utility of HPMC to the Hot Melt Extrusion (HME) process, with an expanded thermal processing window. Neat polymer has been extruded as low as 150°C and as high as 205°C. Both IR and CR profiles are possible with multiple viscosity grades available.
| Heraeus Precious Metals GmbH & Co. KG |
| Dr Friedrich Wissmann, Vice President Operations |
| Weds 23 October 11.00 - 11.25 |
| Heraeus – your partner for cytotoxics, payloads and conjugation |
| Heraeus is a well-established manufacturer for highly potent Active Pharmaceutical Ingredients typically used in anti-cancer therapy since more than 30 years. |
Production capabilities range from inorganic and organic processes to biotechnological operations. Our worldwide customers are all served from Hanau / Germany.
Now we do use our skills in handling highly active APIs to develop new payloads to be used in conjugated drug delivery systems. Here we take advantage from our chemical and microbial development and manufacturing expertise using our perfectly isolated systems.
Additionally, we do work on existing and novel conjugation technologies. Together with our partners we do elaborate smooth and targeted approaches to link novel and known payloads to proteins, antibodies, polymers.
| LGC Standards |
| Dr Christian Zeine, Global Product Manager Pharmaceutical Sector |
| Weds 23 October 14.30 - 14.55 |
| Reference standards: root cause of many FDA 483 observations |
| Reference standards are almost always an issue during inspections from FDA or other regulatory authorities. |
There are a couple of things that can go wrong when handling those materials and using them. And often, these mistakes only become obvious too late, i.e. when the inspectors are already on site, detecting the deficiencies on their own.
This lecture will give a short overview of different types of reference standards, look into case studies of common errors made and give recommendations how to dedicate oneself to this special topic of utmost relevance.
| MVW Healthcare |
| Chris Hall, Vice President and Managing Director, Medical Plastics Division |
| Weds 23 October 12.30 - 12.55 |
| Dispensing Systems and Advancing Adherence to Topical Therapy |
Medication nonadherence is common throughout different routes of administration. While research into oral dose medication adherence is increasing, knowledge about topical medication adherence is a bit limited. Prescribed or recommended medication dosages are often not followed by patients, and poor adherence could lead to failure of the recommended or prescribed topical therapy. There are several marketed and new dispensing systems available to help deliver metered-dose topical medications. This lecture explores how these systems can assist and improve adherence to topical treatments. MWV Healthcare, which has extensive experience in healthcare and pharmaceutical packaging, will review our current topical packaging solutions. We will review market trends in topical products.
| Neogen Chemicals Limited |
| Dr. Harin Kanani, General Manager |
| Tues 22 October 15.30 - 15.55 |
| Bromides, Lithium, Grignard's and more... from India |
Neogen Chemicals Limited is a specialty chemicals company based in India with more than 20 years of experience in Bromine, Lithium, Grignard and Cyclopentyl Chemistry.
The seminar will showcase different bromination strategies and our ability to combine bromination with other chemistries like chlorination, esterification, alkylation, amination, oxidation, grignard reactions to manufacture advanced intermediates under GMP manufacturing conditions.With India's own source of Bromine and years of experience in Bromine chemistry, Neogen offers a unique, reliable Indian source for bromination, specilaity chemicals and pharma intermediates tailor made as per your requirement.
| Novozymes Biopharma |
| Rose Lance |
| Tues 22 October 16.00 - 16.25 |
| An introduction to Enzymes for Biocatalysis |
Novozymes Biopharma is a world leading partner of pharmaceutical and medical device companies offering high-quality and safe biologically-based ingredients and technologies – Hyaluronic acid, Recombinant Albumin and Enzymes for Biocatalysis.
In this presentation we introduce our new area – Enzymes for Biocatalysis. An enabling technology which can help pharmaceutical and intermediate manufacturers achieve enhanced sustainability performance, energy cost savings, and decreased raw material costs. The range of commercial lipases and proteases can be used in chemical transformations in Active Pharmaceutical Ingredient (API) as well as intermediate manufacturing, offering unique advantages. These include high levels of regioselectivity and stereo selectivity in chemical reactions, reducing the length of the process and the use of expensive, toxic raw materials. The selection of lipases includes Candida Antartica Lipase B (Lipozyme®CALB L), Candida Antartica Lipase A (NovoCor®AD L), immobilized lipases such as Novozym® 435 and proteases like Alcalase® and Savinase®. This presentation will highlight how by partnering with us, you gain access to ongoing regulatory and technical support to develop products, which are delivered faster to market with the aim of improving quality of life.
| PHARMCO-AAPER |
| Paul DiMarco, President and General Manager |
| Tues 22 October 13.00 - 13.25 |
| New USP 232 and ICH-Q3D Heavy Metal Mandates! Inside the mind of the FDA – what is their ultimate agenda for the impending USP 232 and ICH-Q3D heavy metal mandates? Find out the potential impact on API and final drug manufacturing for years to come and how PHARMCO-AAPER products meet these requirements today! |
The new USP 232 mandate will eventually be combined with the ICH-Q3D final proposal. What is the FDA's ultimate agenda and how will this change the face of global drug manufacturing for years to come? The FDA views heavy metal concerns as a consumer issue. What does that mean and how will that continue to drive these initiatives? They also want to strengthen cGMP requirements and will use the USP 232 to support that initiative. Find out how. The FDA has articulated their initial position on the new USP 232 standard by requiring the identification and reporting of heavy metals in final drug products. They will no doubt seek the same for the entire supply chain in the future. How is the FDA working to mitigate these significant changes? What other concerns and initiatives can we expect from them and what will be the ultimate impact on EMA, EP requirements?
Join Paul DiMarco, President of PHARMCO-AAPER as he shares his experience in his 20+ year "dance" with the FDA and why his company portfolio of products meet these requirements today.
| Procaps |
| Diego Monterroza, Corporate Manager, R&D |
| Weds 23 October 12.30 - 12.55 |
| Unigel™ Case Study: Extending Soft Gelatin Capsule Benefits to Novel Fixed Dose Combinations |
Fixed dose combinations are desirable for several reasons such as different release profiles and guaranteeing patients´ compliance by reducing the daily intake of a drug product(s). Currently, there are several options for fixed dose combinations like bilayer tablets. However, additional to the manufacturing challenges that this option represents, until now there has not been a fixed dose combination that could incorporate the benefits of soft capsules, like high dose precision, containment for high potent compounds and increased bioavailability for low solubility/permeability BCS compounds, among others. In 2012, Softigel, a division of Procaps, introduced Unigel, a unique technology that allows incorporating the benefit of the softgel dosage form for fixed dose combinations. For this year, Softigel brings a case study that proves the feasibility and benefits of this new technology for combinations of solid and liquid dosage forms and also as a life cycle management extension possibility for your current or future applications, overcoming the challenges faced during product development. The case study relates to combinations of Omega 3 Fish Oil combined with one of the bestselling compounds for cardiovascular therapy.
| Rockwood Lithium GmbH |
| Dr. Armin Stoll, Manager Global Marketing Specialties |
| Weds 23 October 12.00 - 12.25 |
| New Organometallic Tools for Organic Synthesis |
Lithium, magnesium, sodium and zinc based organometallic reagents are used as versatile chemical tools for the synthesis of pharmaceuticals, agrochemicals, flavours, fragrances and other fine organic compounds. Rockwood Lithium offers a broad toolbox of new innovative deprotonation, halogen metal exchange and transmetalation reagents. The commercially available products excel other substances by their high chemoselectivity while meeting today's demands of production departments in any pharmaceutical or chemical company such as safety and environmental regulations as well as operating in a profitable manner. These reagents represent useful tools for directed ortho metalation (DOM) and C-C-coupling reactions such as Kumada or Zn mediated Negishi coupling protocols.
| Rockwood Lithium GmbH |
| Dr. Christoph Krinninger, Manager Global Marketing Specialties |
| Weds 23 October 11.30 - 11.55 |
| Complex Metal Hydrides for Selective Reductions |
Many different types of hydrides are commercially available for the modern synthetic chemist. It is difficult to imagine synthetic organic chemistry without the diverse possibilities offered by these complex metal hydrides. By introducing different substituents the reactivity and selectivity of the hydride can be "fine tuned.
For instance, by replacing three hydride equivalents from lithium aluminum hydride the highly selective LTTBA (Lithium-tri-tert-butoxyaluminumhydride) is formed which can be applied for e. g. stereoselective reductions of amino-ketones.
| SAFC |
| Andreas Weiler, Global Head of Strategic Marketing |
| Tues 22 October 16.30 - 16.55 |
| What is the Future for Western CMO's |
SAFC is the custom manufacturing and services business unit of Sigma-Aldrich Corporation. We are recognized as a top 10 global fine molecule supplier and trusted manufacturer of specialty chemicals and biologics for the life science and high technology industries. Utilizing distinctive technologies and competencies, SAFC is focused on developing tailored solutions that resolve development and manufacturing challenges in order to accelerate speed to market. Our rich portfolio includes high-purity inorganic materials for high technology applications, cell culture products, services for biopharmaceutical manufacturing and biochemical production, and complex, multi-step organic synthesis of APIs and key intermediates.
With the increasing trend to outsource non-core activities to countries that offer perceived cost advantages in terms of low-cost labour, cheaper raw materials and flexibility in terms of production volume, SAFC demonstrates that these gaps can be challenged by a robust, customer intimate strategy, focussing on specialised technologies and services.
| SPI Pharma |
| John K. Tillotson, PhD, R.Ph. |
| Weds 23 October 10.30 - 10.55, Global Applications, Research and Techical Services (ARTS) Manager |
| Actimask® 92S, a Novel, Aqueous-Coated, Taste-Masked Ibuprofen for Direct Compression |
One of the most difficult challenges in formulating chewable and orally-dispersible dosage forms is the taste-masking of APIs. Due to its extensive use in pediatric populations, the taste masking of ibuprofen is of significant interest. Actimask® 92S is a novel, aqueous-coated, and taste-masked ibuprofen specifically formulated for use in direct-compression tableting. Actimask 92S has no residual solvents and provides both an excellent taste barrier and a rapid ibuprofen release which meets compendia standards. Additionally, Actimask 92S has a uniform particle size and excellent flow characteristics. Actimask 92S taste-masked ibuprofen is the ideal taste-masked API for the direct compression formulation of both chewable and orally-disintegrating tablets, as well as for the formulation of orally-dispersible powders.
| The Purolite Company |
| Dr. Alessandra Basso, LifeTech Manager |
| Weds 23 October 16.00 - 16.25 |
| Industrial immobilized enzymes: processes, economics and key applications |
In theory, every enzymatic process can benefit from immobilization of the biocatalyst resulting from economic improvements due to enzyme recyclability. In practice, these benefits can be achieved through a deep understanding of the interactions between the enzyme and carrier with the chemical matrix in which the enzymatic step takes place. Activity, stability (recyclability) and selectivity of the final immobilized biocatalyst can be highly influenced by the type and characteristics of enzyme carrier as well as the enzyme immobilization technique used. Purolite has developed new advanced technologies for enzyme carrier manufacture that allow to customize and increase economical benefits for the final user.
Successful implementation of an immobilized enzyme process is ultimately dependent on cost-effectiveness, which is influenced by various factors, such as: a) enzyme performance and cost, b) carrier cost, c) efficiency and cost of immobilization process, d) stability (recyclability), and e) chemical processing advantages.
Here we present some successfull cases of application of enzyme carriers or immobilized enzymes applied to major industrial processes, in pharma, food or fine chemistry.
| Thermo Scientific Portable Analytical Instruments |
| Shailesh Karavadrav |
| Weds 23 October 13.00 - 13.25 |
| Material Identity/Verification with Thermo Scientific Handheld Spectrometers |
Material Identity or Verification – Embrace the Future with Thermo Scientific's handheld spectrometers.
| Winclove Probotics |
| Catherina (Karen) Koning, Senior Scientist and CRM Winclove Probiotics |
| Weds 23 October 13:30 - 13:55 |
| What can probiotics do in health? Ecologic®: clinically proven designer multispecies probiotics |
|Modern health care faces complex, often multi-factorial, diseases which ask for innovative therapies. Probiotics are capable of addressing multi-factorial diseases. This presentation will discuss the efficacy and working mechanism of Ecologic®, evidence-based, disease-specific probiotic formulations, in different diseases and disorders.|
| || Thomson Reuters |
| Ludivine Pennaneach, Solution Specialist, Newport |
| Tues 22 October 14.30 - 14.55 |
| For Companies Nearing the Patent Cliff- are Biosimilars the Parachute? |
|Between 2013 and 2018 it is expected that over 150 small molecule products will lose patent protection and become subject to generic competition. Innovator companies are looking to new sources of revenue to fill gaps left in the wake of the looming ‘patent cliff', one of which is biosimilars. But will biosimilars and follow-on biologics provide companies with the opportunity they are looking for? Even for aggressive companies with biologic manufacturing capabilities, finding the right biosimilar candidate involves analyzing the current market and recent deals in the biologic space, evaluating biosimilar clinical trials globally as well as understanding manufacturing methods needed to pursue or partner for an opportunity. This presentation will provide information on these topics, and look ahead at what to expect in the biosimilar market.|