newsflashPHARMACEUTICAL SYSTEMS

ISSUE 24 | March 2016

Crystal Clear Insight

It’s clear that as the market be-comes more complex and chal-lenging, the pharma industry and its suppliers must become better, faster and smarter than ever be-fore. The “Insight Forum for Ready- To-Use Solutions in Aseptic Manu-facturing”, organized by SCHOTT in 2015, was designed exactly along that line.

The event brought together cus- tomers, vendors and suppliers for an open discussion of the challen- ges and benefits of ready-to-use (RTU) systems, and to show how a

coordinated effort can bring new packaging solutions to the rapidly changing pharmaceutical market. Partners in attendance included Bausch + Ströbel, GEA Lyophil, ARaymond Life, and West Pharma-ceutical Services. The keynote ad-dress was delivered by the US bio-tech company Amgen, emphasizing the need for closer partnerships between the pharma industry and its suppliers in order to uphold pa-tient safety, reduce particle conta- mination in packaging, and secure the supply chain.

Our flexible future The Insight Forum brought to

the fore several of the wider trends in the industry, and their impact on packaging suppliers. Andreas Reisse, Executive Vice President of SCHOTT Pharmaceutical Systems, opened the event by addressing the growth of the specialty me- dicines market, which is driving demand for smaller-volume ma- nufacturing and greater flexibility. This was an ongoing theme throughout the event, along with the increasing cost pressure on manufacturers and the demand for a wide range of packaging options.

“The environment in which we operate is changing constantly,” explained keynote speaker Ronald Forster, Executive Director Device Technology at Amgen. “As more patients around the world are gaining access to our medicines, supply chains are constantly grow-ing and becoming more complex. Market demands continue to shift. The need for adaptive manufac- turing is growing. In addition, reg-ulatory agencies are constantly rais- ing the bar of what they expect from us. It’s a dynamic situation.”

Together, these factors have led Amgen to reevaluate their manu-

facturing strategies, said Forster, moving towards adaptive manu-facturing. Amgen has already built a next generation single-use sys-tems (SUS) drug substance facility in Singapore. Without the tradi-tionally huge overheads of tradi-tional plants, it allows faster, more flexible production, with a signifi-cantly smaller footprint.

Suppliers team upPackaging suppliers are well

aware of the challenges facing their customers, and are working on solutions to fit these trends. Bausch + Ströbel’s Markus Hoersch picked up the twin themes of flex-ibility and small footprint when discussing the rationale behind the VarioSys platform – a small stan-dard isolator, which can accom-modate various container types, while Gregor Deutschle, Product Manager at SCHOTT, described their new system of RTU vials called adaptiQ® as “a perfect fit” for the wider trends in the indus-try. “Smaller batch sizes and high-value drugs make a nested system particularly appealing to protect the vials and their contents from cosmetic defects and make switch-ing between products easier.”

NEWS

PREVIEW

EDITORIAL

PRODUCTS – SCHOTT Increases Produc-tion of Polymer Syringes by 50 %. Read more on page 2.

TUBING – GMP Certification for all Pharmaceutical Tubing Sites. Read more on page 4.

INNOVATION – SCHOTT Expands Delami- nation Control with new large-format Vial.Read more on page 3.

MARKETS – New Manufacturing Site for Pharmaceutical Packaging in China. Read more on page 4.

Dear Reader,To be truly flexible, drug

products and their packaging must work seamlessly in systems up and down the supply chain. As we explore in this newsflash, there are already some exam-ples for successful cooperation: our SCHOTT Cartridges HS, which were especially designed to meet the requirements of highspeed filling lines. Or the first large-sized de lamination controlled vial we successfully developed and validated in a customer project. Last but not least the lead story of this issue – our SCHOTT Insight Forum, which brought together pharma companies and suppliers.

In short: It’s time for all of us to team up. Therefore, we were all the more thankful that so many of you contributed to our recent customer survey. Your detailed feedback provides us with very valuable insights. It also clearly confirmed that we maintain close contact with our customers. We at SCHOTT believe that this is the way to truly add value.

I hope you enjoy reading our latest newsflash.

Andreas ReisseExecutive Vice PresidentPharmaceutical Systems

Continued on page 2

newsflash | March 2016 2

True patient focus As drug products become more

complex, there is an increasing recognition that to offer truly in-novative solutions, suppliers must have a complete understanding of the supply chain, including the end user – the patient. Forster set the tone in his presentation, stat-ing that patients depend not only on Amgen but all of its suppliers.

“Suppliers need to appreciate that the end customer is not the pharmaceutical company – it’s the patient. Concentrating on our own processes is no longer enough – we need to understand the cus-tomer’s processes right through to the patient,” said Chris Sellards, co-Chair of the event and General Manager of SCHOTT’s Lebanon plant.

“One has to really understand the intended use, and put the patient at the center of the deci-sion,” added Anil Busimi, Director Strategic Marketing and Innova-tion, for SCHOTT.

Putting patients first means that the quality of the end product has to be the number one priority for suppliers and pharma alike. Shifts in technology and markets have thrown up challenges for quality and supply chain manage-ment, reflected in a fourfold in-crease in drug shortages between 2005 and 2011. Forster said Am-gen is proud to have never shorted the market. Preventing such short-ages was a key tenet of their strat-egy and suppliers have an import-ant role to play.

A quality by design approach is crucial when making decisions about all aspects of packaging. Legacy equipment may not be the best fit for innovative new drug products, and it’s important that pharma customers weigh up all the options when choosing pack-

aging components. Speaking about the choice of container closure sys- tems, West’s Pegg Frandolig said, “One of the most common mis-takes customers make is to stick to what they know.”

Busimi, discussing the choice between polymer and glass, also urged careful consideration. “There are a lot of misconceptions about both glass and polymer products. Companies need to carry out an in-depth analysis of the pros and cons of both materials, rather than jumping to conclusions.”

Innovation in packaging may not be as dramatic as a new drug product, but it can have a real im-pact on quality and cost, which in turn can determine whether a pa-tient even receives the drug. And suppliers once again have a seri-ous role to play in cost. “Some will say, what’s so innovative about adaptiQ®? Pharma companies have been doing RTU for 100 years al-ready,” said Michael Vollgold, VP Global Sales & Marketing, SCHOTT. “But the innovation lies in the nest, which allows you to carry out operations more efficiently and protect the container. That is cru-cial for today’s high-value bio- tech drugs, where each vial can cost $500.”

In it together Forster concluded his presen-

tation by saying, “We need to change the way we work. In order to meet the needs of our custom-ers we have to move much faster – and have more confidence.” As emphasized by speakers and at-tendees throughout the day, part-nership is the only way to achieve that change, and cooperation was the overriding theme of the event.

Nigel Ware, Business Develop-ment Manager at ARaymond, agreed: “As demonstrated in to-day’s event, collaboration across

the whole network is crucial. As a part of the pharmaceutical indus- try, our expectation and obligation is to create the best product, and we can only do that by working together with our partners.”

Hoersch noted that adaptiQ® is a good example of cooperation between suppliers. SCHOTT ap- proached machine builders, cus-tomers, and other partners from an early stage to work together on the design of the system, and the depth of collaboration was apparent from the two panel ses-sions, with contributions from five of those partners, making every-thing from filling line machinery to closure systems to freeze dryers.

A matter of trustRTU systems, by definition, re-

quire a level of trust; customers are relying on the supplier to carry out steps that are critical to quality. Responding to a question from the audience on this point, Deutschle said, “It highlights the importance of transparency and partnership with our customers – allowing them to view all our pro-cesses to show them how we make sure they get a good product, ev-ery time.”

If the era of transactional rela-tionships is really over, as Forster contends, pharmaceutical indus-try suppliers need to find a new path. What will that look like? The key themes from the Forum sug- gest that successful suppliers will need to be focused on the pa- tient, committed to quality, and willing to partner up to provide the best solutions.

“Ron Forster put it perfectly when he said that if we want to im-prove patient’s lives, we have to find new ways of working. One company can only contribute. We need a collaborative effort to truly change the game,” concluded Vollgold.

NEWS

Crystal Clear Insight Continued from page 1

This article appeared originally in „The Medicine Maker“

SCHOTT Increases Production of Polymer Syringes by 50 %SCHOTT is currently expanding the manufacturing capacity for its SCHOTT TopPac® prefillable poly-mer syringes to address increasing customer demand. The new pro-duction line will be installed at the company’s center of excellence for pre-fillable syringes in St. Gallen, Switzerland. This move will offer a greater degree of flexibility for customers and further strengthen the importance of the Swiss site which focuses on both, glass and polymer syringes.

“The demand for our polymer syringes has increased since cus-tomers appreciate the versatile ad-vantages of the material: It’s break resistant and lightweight, yet has

a glass-like transparency. And the excellent barrier properties of the SCHOTT TopPac® syringe system keep the drug stable over shelf life”, says Anil-Kumar Busimi, Di- rector Strategic Marketing and Innovation, SCHOTT AG.

The new production line will seamlessly be integrated in SCHOTT’s existing setup which uses advanced technologies. SCHOTT TopPac® syringes are manufactured in clean rooms with a fully automated process starting from injection-molding to the fi-nal packaging in nest and tub. The syringes are sterilized and ready for aseptic filling operations.

Complete Syringe PortfolioSCHOTT has been manufac-

turing glass and polymer syringes in Europe since 1996. Today, the production is concentrated in Switzerland and is supported by an R&D team based at the site.

From here SCHOTT has devel-oped a complete portfolio of both glass and polymer syringes. This offers pharma companies a broad range of solutions, suitable for a variety of applications like heparin, vaccines, biotech, and special ap- plications such as intensive care.

In the field of glass syringes, the offerings range from 0.5 to 3 milli-liter (ml) products marketed under

the brand name syriQ®. All glass syringes are available with luer lock, luer cone or with staked needle.

SCHOTT TopPac® polymer sy- ringes, in turn, are available in the range from 1ml to 50ml with cross linked silicone for optimal func-tionality. In addition, the company has recently introduced an inno-vative polymer syringe designed to improve the safety of sensitive drugs: the new product named SCHOTT TopPac® SD offers new features for a significantly reduced E&L (Extractables and Leachables) profile and ensures high drug sta-bility.

PRODUCTS

newsflash | March 2016 3

INNOVATION

SCHOTT Expands Delamination Control with new large-format Vial

SCHOTT has developed the first large pharmaceutical vial that provides a reduced delamination propensity and decreases the risk of product recalls significantly.

In a customer project for a US-based biotech company SCHOTT succeeded in applying its proven manufacturing process for its delamination controlled vials to a

customized 50 milliliter vial.In response to the pharmaceu-

tical industry’s delamination con-cerns surrounding the storage of pharmaceutical products in glass vials, SCHOTT has combined high- quality FIOLAX® glass tubing with an optimized hot forming process, as well as a quantitative chemical glass surface test routine, to develop

SCHOTT Vials Delamination Con-trolled (DC). The DC manufactur-ing process ensures the glass sur-face is more homogeneous and therefore less susceptible to de-lamination. Currently, the compa-ny’s portfolio includes ISO sizes from 2R to 10R. Through this cus-tomer project, SCHOTT has proven its capability to apply this know- ledge to large and customized vi-als as well.

Validation through Delamination Quicktest, not Alkalinity

SCHOTT is the first manufac-turer capable of determining the risk of delamination based on threshold values. During the com-pany’s patented Delamination Quicktest, a certain number of vials are randomly removed from every batch and subjected to stress for four hours inside an au-toclave to identify the delamina-tion critical zone. In a second step, the vials are filled with high purity water (WFI – Water for Injection) and sodium is extracted inside an autoclave. The amount of sodium

extracted correlates with the prob-ability that the vials will experi-ence delamination at a later point in time. “By monitoring these values and adhering to cer-tain thresholds, SCHOTT is able to control the risk of delamination,” says Dr. Bernhard Hladik, Senior Product Manager at SCHOTT Phar- maceutical Systems. “We validated the new customized 50 ml vials with the SCHOTT Delamination Quicktest, which from our point of view is the most suitable method to minimize the manufacturing

related risk for glass delamination. The first approach trying to quan-tify the delamination tendency was based on limiting the surface alkalinity of the respective con-tainer. However, SCHOTT found that vials that scored well in the surface alkalinity test still showed a high tendency to delaminate if the SCHOTT Delamination Quicktest was not passed. There- fore, SCHOTT only uses the prov- en SCHOTT Delamination Quick- test to measure the risks of de-lamination.

A Cartridge Designed for High-speed Filling

With regulatory institutions em-phasizing dosage accuracy, the combination of high speed filling and superior level measuring has become a key requirement, espe-cially in the area of highly con-centrated drug formulations. In response to this trend, SCHOTT has developed high-tech glass cartridges that are tailored for the requirements of laser-controlled, high-speed filling lines. SCHOTT Cartridges HS were designed in close cooperation with leading machine manufacturers such as Bosch Packaging Technology to enable quicker processing and reduce overfill losses.

Experts believe that diabetes patients already account for more than five percent of the adult po- pulation of our planet. That would be over 200 million people. The World Health Organization (WHO) and the International Diabetes Federation expect this figure to increase to 333 million by 2025. “To meet the growing demand for insulin, more and more pharma-ceutical companies are manufac-turing on so-called high-speed filling lines. But high-speed filling comes with special quality require-ments for the cartridge”, explains Andrea Wesp, Global Product Man-agement Cartridges at SCHOTT.

For instance, in order to opti-mize the total cost of ownership, several vendors have started using laser light and sensors to accu-rately control fill levels and so en-sure optimal bubble-free dosing and less product loss through over- filling plus reduce downtimes on filling lines.

Dedicated to customer-driven product development, SCHOTT experts have teamed up with lead customers in order to translate those process requirements into a new product design. This includes defining the neck specification with respect to straightness and cosmetic defects. “The demands are

extremely high. After all, up to 600 cartridges per minute are being filled,” Wesp says. “With SCHOTT Cartridges HS we have reached a very precise neck geom-etry. This improved design exactly meets the demands of laser con-trolled high-speed filling lines.”

Proven manufacturing processSCHOTT also lays great empha-

sis on the manufacturing process. “Handling the cartridges gently during production facilitates tight dimensions and premium surface quality. This further improves their processability”, Wesp confirms.

The production of SCHOTT Cartridges HS (High Speed) has been installed in St. Gallen, Swit-zerland where SCHOTT’s center of excellence for cartridges is based. All production processes were established according to the high- est international industry standards and can also accommodate spe-cific customer requests.

Bundled knowledge

A new book written by SCHOTT scientist Dr. Bettine Boltres provides pharmaceuti-cal companies with basic know- ledge of glass and how this ma-terial is used best in the phar- maceutical industry.

“When Glass meets Pharma” succinctly describes what char-acteristics the material has, why it possibly interacts with drugs and how it can be processed most effectively in production. “By sharing our knowledge of glass with companies in the pharmaceutical industry, we help them to use glass more effectively,” Boltres describes her motivation for writing the book.

The book has been pub-lished in English by Editio Can-tor Verlag (ISBN 978-3-87193-432-2). The print and eBook edition is now available in stores and at amazon.com.

Screening StudiesSCHOTT conducted a set of

screening studies in accordance with USP 1660 to confirm the effect of delamination control. These studies comprised formu-lations which were involved in recalls reported by the FDA, such as 10 % sodium thiosulfate solu-tion and 15 % potassium chlo-ride solution. Both formulations were stored for 12 weeks at 60 °C and 48 weeks at 40 °C. Further-

more, SCHOTT conducted stu-dies with commonly used buffer systems: purified water, citrate, phosphate, sodium bicarbonate, and EDTA, which were stored for 48 weeks at 40 °C. For all tested formulations SCHOTT Vials Dela- mination Controlled did not ex-hibit delamination while conven-tionally manufactured Type I vials showed delamination or asso- ciated preindicators.

newsflash | March 2016 4

New Manufacturing Site for Pharmaceutical Packaging in ChinaSCHOTT Xinkang laid the corner-stone for a new Asian manufactur-ing site for pharmaceutical pack-aging that will be located south of Shanghai. Starting in 2017, glass packaging for injectable drugs will be manufactured here, in particu-lar vials and ampoules of the high-est quality.

Furthermore, the SCHOTT Group also plans to modernize and ex-pand its existing facilities at its integrated site in Suzhou. The Pharmaceutical Systems division of SCHOTT will invest approx. EUR 30 million in total in China over

the next three years. These mea-sures will increase the company’s production capacity by 50 per cent over the same period.

“With this expansion, we are paying tribute to the strong growth of the Chinese pharmaceu- tical market ”, says Chen Guangxin, General Manager of SCHOTT Xinkang. “It is our declared goal to be the best partner for the pharmaceutical industry in supply-ing them with top-quality pack- aging. With our expansion we furthermore support our custom-ers’ growth plans. In fact, SCHOTT

Xinkang will set highest standards for the production of pharmaceu-tical packaging in China.”

SCHOTT Xinkang is a joint ven-ture of Zhejiang Xinkang Pharma- ceutical Glass Co. ltd and the international technology group SCHOTT AG which came into op-eration in 2012. “The founding of SCHOTT Xinkang is a true success story that we would now like to continue writing by opening the new plant,” says Executive Vice President Andreas Reisse, respon- sible for the Pharmaceutical Sys-tems division.

GMP Certification for all Pharmaceutical Tubing Sites

SCHOTT’s glass tubing plant near Mumbai, India, has achieved official Good Manufacturing Practice (GMP) compliance. GMP is an international standard in the pharmaceutical industry that brings together guidelines to ensure the quality of critical pro-duction processes. The certificate, presented to SCHOTT by TÜV Rheinland, underlines the compa-ny’s global commitment to those standards. In fact, SCHOTT is now the only supplier of pharmaceuti-cal tubing worldwide that has been recognized as working to GMP standards at all its manufac-turing sites.SCHOTT manufactures glass tub-ing in Europe, South America and Asia, with a total production ca-pacity of more than 140,000 tons. Tubes made of FIOLAX® specialty glass are the basis of many phar-maceutical packaging solutions, being converted into syringes, vials, ampoules, and cartridges. These containers need to safely store medication, sometimes for years, without compromising the effectiveness of the drug, meaning quality of the glass is key.

“SCHOTT considers quality assurance central to the production of pharmaceutical glass,” explained

Dr.-Ing. Karsten Hennig, Director of Quality Management at SCHOTT Tubing. Hennig contin-ued, “It is therefore established practice for SCHOTT to work to GMP standards at all our facili-ties.”

Risk management from the very beginning

The GMP guidelines comprise a series of general principles, like documentation and hygiene, that must be observed during the manufacturing process. More and more countries are specifying GMP as a statutory requirement that pharmaceutical companies and suppliers of quality related components to the industry must meet.

These rules have become a top priority also for the produc-tion of tubing. “In order to pro-vide patients with safe pharma-ceutical products of the highest standard, quality has to be made the primary focus from the very beginning of the value chain,” Hennig added, “By earning GMP certification at all of our produc-tion sites of FIOLAX® glass tubing around the world, we are helping our customers to eliminate all po-tential risks facing the patient.”

SCHOTT Expert Receives Turner Award

The International Commission on Glass (ICG) has presented its pres-tigious Turner Award to SCHOTT researcher Prof. Volker Rupertus. With this prize, the organization recognizes his many years of ac-tive support to the ICG’s Tech- nical Committees and his exper-tise on the surface characteristics of glass.

Building on this, Rupertus has done pioneering work on devel-oping a quick test for monitoring the propensity of glass delamina-tion occurring in pharmaceutical

vials. His scientific work is one key element of SCHOTT’s recent inno-vation SCHOTT Vials Delamina-tion Controlled, a pharmaceutical vial that significantly reduces the risk of delamination and helps to keep the drug stable over its shelf life.

Volker Rupertus was part of a team of SCHOTT scientists who examined the basic mechanism of delamination behavior and con-sequently developed a production process for manufacturing glass vials with appropriate surface

conditions. Based on this team re- search, Rupertus finalized a test-ing procedure for controlling the delamination propensity of glass vials during production – the SCHOTT Delamination Quicktest (see page 3).

The award, which is named after ICG’s first President, Professor W.E.S. Turner, was officially presen- ted to the SCHOTT Scientist at the Commission’s annual meeting held in Bangkok.

Volker Rupertus studied tech- nical physics at the University of Kaiserslautern and earned his PhD in the field of glass surface science. In 1995, he started his career at SCHOTT’s central R&D depart-ment. As head of the analytical department, he worked with his group for more than a decade for several SCHOTT divisions in the field of process development & characterization. In 2010 he joined the BU Pharmaceutical Systems as Head of Global Quality. Today, Rupertus performs an advisory function as Senior Principle Ex-pert for SCHOTT’s Pharmaceuti-cal Systems business unit. Since 2002, Rupertus has also been giv-ing lectures in the field of materi-als analysis and was appointed Honorary Professor at the Techni-cal University of Clausthal.

Meet SCHOTT in 2016 PDA Parenteral Packaging Venice (IT), April 12 – 13

Interphex, New York (US) April 26 – 28

CPhI SEA, Jakarta, (IDN) April 26 – 29

Koreapack, Seoul, (KOR) April 26 – 29

CPhI China, Shanghai (CN) June, 21 – 23

CPhI Worldwide, Barcelona (ES) October 4 – 6

EXHIBITIONS & EVENTS

NEWSFLASH

Issue 24 | March 2016

Copyright 2016: SCHOTT AG

Layout: Knecht Digital- und Printmedien

Photos: SCHOTT AG

Reproduction allowed only with the permission of the publisher.

Address: SCHOTT Pharmaceutical Systems

Hattenbergstrasse 10

55122 Mainz / Germany

The following product names are registered brands or product names of SCHOTT:

FIOLAX®, adaptiQ®, SCHOTT TopPac®, syriQ®

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MARKETS

TUBING

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