Addressing the detailed and complex issues associated with sourcing, manufacturing, outsourcing and delivering consistent pharmaceutical products to the market
Making Pharmaceuticals running from the 25–26 April
Running from the 25–26 April, Making Pharmaceuticals brings together the leading figures from the UK pharmaceutical industry for 2 days of comprehensive technical conference content, which is presented by key experts and leading pharmaceutical organisations.
During the 2-day event, visitors are able to attend a series of seminars compiled by a number of leading authorities in the UK, as well as the largest pharmaceutical exhibition in the country.
Making Pharmaceuticals 2017 opens its doors to the pharmaceutical community at a brand-new venue, the Ricoh Arena, Coventry.
Attendees to the event will also be able to speak with representatives in the exhibition from more than 100 companies that are at the forefront of developing the products, services, technologies and expertise that will drive the industry forward in the coming years, increasing production capabilities and ensuring the UK remains at the cutting edge of an increasingly global and competitive sector.
This year’s conference offers four streams of content running simultaneously during the 2-day event, covering topics such as medical devices, regulatory affairs, pharmaceutical quality, APIs and excipients, packaging, clinical trials, processing, good manufacturing technology, cleaning validation and a host of other topics. The contribution to this year’s conference has come from a number of pharmaceutical experts as well as many leading organisational bodies, such as ABPI, Cranfield University, CPI, IPEC Europe, EXCiPACT, IMechE, Pharmig, Be4ward, The ICR, PQG, CQI and ISPE, among others.
Making Pharmaceuticals is the only dedicated event in the UK that addresses the detailed and complex issues associated with the science and business of drug production, and overcoming the hurdles the industry faces to deliver pharmaceutical products to the market.
Since its launch in 2014, Making Pharmaceuticals has seen unprecedented growth, with both visitor numbers and the exhibition growing by more than 50% year on year, and 2017 will be no exception. Register for free at www.making-pharma.com and book your place at the UKs’ premier pharmaceutical exhibition and conference.
Renishaw’s RA802 pharmaceutical analyser
The RA802 pharmaceutical analyser from Renishaw (stand 324) is a compact benchtop Raman imaging system, designed exclusively for the pharmaceutical industry. This easy-to-use instrument redefines how Raman spectroscopy is used for formulation analysis. The RA802 enables users to formulate tablets more efficiently by speeding up the analysis of tablet composition and structure. It brings together the chemical analysis power of Raman spectroscopy and advanced imaging technologies in a powerful, robust system. Users can reveal detailed chemical and physical information about the contents of their sample, from the distribution and size of API domains to their physical topography. The RA802 makes the highest performance Raman spectroscopy accessible to all users.
The system uses Renishaw’s latest innovation, LiveTrack focus tracking technology, to enable users to analyse samples with uneven, curved or rough surfaces at incredible speeds without requiring any sample preparation. Intact tablets can be analysed, or they can be split or sliced to reveal their internal structures. LiveTrack continuously adjusts the sample’s height, producing information-rich three dimensional chemical maps of a tablet’s surface.
Tim Smith, Head of Applications, said: “The RA802 makes the Raman analysis of tablets, powders, granules, liquids and sprays simple. Users can obtain detailed information about the distribution of chemical species faster with the simplest sample preparation. It provides users with a practical solution for analysing formulations and gives great results without complexity.”
Making Pharmaceuticals offers the Lovibond teams an opportunity to unite, showing a range of colour measurement and water analysis instrumentation on stand 402. Water is the most commonly used liquid in pharmaceuticals — not only as an ingredient but throughout the entire process (from raw water, boiler water, and cooling water to effluents).
Furthermore, as purified water is a basic requirement of the pharmaceutical industry, it is essential to make sure that quality is monitored throughout. Lovibond water analysis equipment is easy-to-use yet unsurpassed in its accuracy and repeatability. The portfolio includes photometry for the precise determination of every parameter (acidity to zinc), electrochemistry for pH, conductivity, TDS and temperature, dedicated systems for BOD and COD determination, turbidity meters and microbiology testing kits, including the new range of dipslides for aerobic and anaerobic bacteria levels. With electronic photometers, visual comparators and bespoke test kits, the range is suitable for every application and budget.
Pharmaceutical and cosmetic products are produced in many forms: from powders and granules to pastes and liquids. The colour of these products is important in the identification, safety and aesthetic value of the final product as well as a way to measure the progress of processing. Pharmaceutical colour is also an important indicator of degradation. As such, colour measurement is widely practiced, both in the laboratory and manufacturing, and is documented carefully to avoid any inconsistencies in pills and medicines. There are several international standards and colour scales to ensure inter-company agreement on an international level.
Defining the colour of a product and ensuring colour accuracy every time is critical to long-term success. Reliable, repeatable colour test results ensure final product quality and minimise production costs. Speed of analysis is vital for efficient process control. Simplicity of operation reduces error and increases productivity. The Lovibond range of colour measurement products enables this with instruments to measure liquids, solids, pastes and powders.
MG2 introduces its new Pharma Zone
The Bologna-based firm, a specialist in the design and marketing of capsule fillers and end-of-line solutions, recently inaugurated several new pharmaceutical-compatible cleanrooms to provide a safe working environment to perform an expanded range of tests.
The new “Pharma Zone,” comprising three cleanrooms, allows dosage trials, scale-up, final tests and the validation of pharmaceutical processes to be done with active products in actual production conditions. Many pharmaceutical companies use contract manufacturers to assess development-scale technical batches. Now, thanks to the installation of its cleanrooms, MG2 has expanded its range of available services, supporting its customers from the design phase to premarket testing.
With an initial desire to increase employee safety, MG2’s new cleanrooms have been operating since the beginning of September 2016, thus increasing the area dedicated to tests and trials and bringing the number of rooms dedicated to these activities to six.
The rooms are completely autonomous; everything was arranged with controlled access to avoid cross-contamination, including the aisles and changing rooms. Operators are required to undertake special training before entering the cleanrooms, and to follow specific protocols. As a further security guarantee, each environment features constant air recirculation.
Parameters such as temperature and humidity can be altered according to the product being tested, and each room is equipped with computer workstations, wash stations, weight control systems and complete tool sets to guarantee maximum levels of autonomy for each working environment.
Mentholatum goes live with LabHQ LIMS
Broughton Software, the developer of LabHQ LIMS, the leading laboratory information management system (LIMS) for quality control, has announced its collaboration with Mentholatum, the manufacturer of high quality healthcare products and the home of world famous brands such as Deep Heat. This had led to the deployment of LabHQ LIMS at their quality control laboratory in East Kilbride, UK.
LabHQ LIMS version 4 has been developed with input from Broughton Software’s clients and its network of regulatory, quality and laboratory professionals, resulting in a system that is perfectly suited to support the activities of a busy quality control laboratory. The decision to deploy LabHQ and replace a previous LIMS system was driven by four key requirements: delivery of a validated system, regulatory compliance, accessibility through a web-based system and data security. The system will initially be used to analyse, manage and store quality control test data. Future plans include the potential addition of modules to manage stock and stability trials.
Broughton Software Commercial Director, Andy Mooney, commented: “We are pleased to welcome Mentholatum to our growing list of clients. With our background in quality control, via our sister company Broughton Laboratories, we are uniquely placed to understand the challenges that Mentholatum is facing. We have worked closely with Tracy and her team to deliver an easy to use LIMS system that will facilitate regulatory data integrity requirements and has been configured to meet Mentholatum’s specific business needs.”
Mentholatum Laboratory Manager, Tracy Morton, added: “It has been a pleasure working with the team at Broughton Software; they have provided invaluable support and expertise that has given us the confidence to introduce this improved LIMS system into our tightly regulated industry. Everyone at Broughton has been extremely friendly and the deployment process has proven to be highly enjoyable. The design of the LabHQ LIMS system means it is very well suited for the quality control laboratory and is easily customisable to meet our individual needs.”
Pharmaceutical contract packer, Chester Medical Solutions (stand 216), has selected Mettler-Toledo to provide its serialisation solution, based around XMV TE track and trace technology. The XMV TE system is an advanced inspection system that integrates three processes — combining inkjet printing and image verification with secure, tamper-evident sealing. Installation is scheduled for Q1 2017.
The system complies with EU delegated act 2011/62/EU and EN 16679, enabling Chester Medical to offer fully compliant serialisation solutions to its clients, including full aggregation and the ability to rework previously serialised product. Chester Medical Managing Director, David Patterson, stated:
“This investment will ensure that we are well ahead of the curve in ensuring that our business, and that of our customers, is prepared for the adoption of serialisation.”
Raman raw material analyser integrates new chemometrics capabilities
Pharmaceutical and biotechnology manufacturers seeking the flexibility to build their own qualitative and quantitative methods for complex material analysis problems can now rely on the Thermo Scientific TruTools capability embedded in the Thermo Scientific TruScan RM handheld analyser.
TruTools is a fully integrated chemometrics package that leverages Eigenvector Research Inc.’s SOLO standalone chemometrics software. Advanced TruScan RM users can customise their acquisition parameters, including number of scans, exposure time and laser power, then export the scan data in an SPC file format. This data is imported into SOLO, wherein users can build custom models that can then be deployed onto the TruScan RM handheld analyser.
The TruScan RM uses lab-proven Raman spectroscopy to perform rapid and reliable material identification at the point of need, decreasing laboratory sampling costs. With its patented multivariate residual analysis and two spectral preprocessing options, the analyser measures a broad range of solid and liquid materials.
As a contract development and manufacturing partner for active pharmaceutical ingredients and finished dosage forms, Aesica helps its customers to meet their goals. Fraud prevention is a key concern, and to combat it, serialisation legislation is being developed and implemented across the world.
Aesica can support customers with a serialisation solution that can be adapted to meet their varying needs. For example, to support continued trading in countries with legislation in place, such as China and South Korea, by ensuring every pharmaceutical product pack is uniquely identified with a serial number.
Since 2009, Aesica has been investing in a modular serialisation system that is flexible and scalable, and is now implemented and fully operational at all of its packaging sites. With production lines first going live in Italy in 2013, it was one of the first CDMOs to implement serialisation. Aesica will continue to invest to meet the anticipated future industry needs, for example, by further developing its aggregation capability to serialise to the pallet level.
To find out more about serialisation and tips for implementing your own solution, visit Aesica’s stand (318) at Making Pharmaceuticals or by emailing firstname.lastname@example.org.
David Staunton, Director of Global Managed Services at Zenith Technologies
A global life science technology firm has appointed David Staunton as Director of Global Managed Services to help meet increased demand for its automation and manufacturing execution system (MES) services. Currently Zenith Technologies’ managed services provide 24/7 front line support and operation of clients’ automation and MES systems. The next generation of managed services will have an increased focus on multiplatform support and cost reduction. Zenith Technologies now offers managed services that support eight major platforms developed by Emerson, Siemens, Rockwell, Sneider, OSiSoft, Werum and Aspentech. This provides clients with a clear picture of their entire automation and MES landscape to reduce costs and increase reliability.
Having worked for several tier one pharma companies, delivering large-scale automation and process control projects, David will use his experience to continue to develop Zenith Technologies as a world leader in the provision of managed services to the life science industry. Jim Lehane, Director at Zenith Technologies, said: David will be focused on achieving the main goal of our managed service offering, which is to ensure that manufacturers in the life science sector get the most from their automation and IT systems, reducing their total cost of ownership and improving business operations.”
Zenith Technologies first introduced the managed services model to the market in 2006 and, since then, it has grown rapidly because it delivers more reliable, lean and effective automation and MES systems. Jim continued: “In essence, we stand shoulder to shoulder with our clients on their continuous journey to improve their automation and MES systems.”
Based in Dublin, David said: “Zenith’s founder Brendan O’Regan has established a world-class team, including more than 700 of the best automation and MES experts in the industry, and I am delighted to be part of that team. I have first-hand experience of the business benefits that automation and MES can bring when implemented and managed correctly.”
“It’s an exciting time for the life science sector. The industry is on the edge of change. The current capital boom and the potential for disruptive technology to reform the sector, means that if we work together, we can really make things better for the patients we serve.”
Zenith Technologies is one of the leading companies in delivering the full lifecycle of automation and MES systems, enabling life science businesses to be compliant and competitive.
Recipharm, the contract development and manufacturing organisation (CDMO), has kickstarted its campaign to introduce its customers to new processes for pharmaceutical serialisation. In February 2016, the CDMO announced plans to lead the market in preparing for new regulations to improve the traceability of drugs throughout the supply chain and invest more than r40 million into new systems and processes across around 75 production lines in Europe.
Just one year on, Recipharm has launched a fully operational line for serialisation at its facility in Fontaine, France, and is engaging with customers to start the onboarding process. From January 2018, the company will offer its drug serialisation service free of charge until it becomes a legal requirement in Europe in February 2019, allowing customers to overcome any challenges, determine their individual requirements and request any customisation before the legislation comes into force.
The CDMO’s company wide serialisation project is being led by Staffan Widengren, Director, Corporate Projects at Recipharm. He said: “During the past couple of months, several of our customers, ranging from mid-to-large pharma, have visited our facility in Fontaine to view and trial our showcase line for pharmaceutical serialisation. The response we have received has been extremely positive, with customers feeling that our proactive approach to preparing for the changes will save them a lot of time and guarantee continuity of product supply when the new regulations take hold.”
Our proactive approach to preparing for the changes will save them a lot of time and guarantee continuity of product supply when the new regulations take hold.”
BCMPA serve customers looking to outsource their clinical trials, pharmaceutical manufacturing and packaging
As part of the original steering group for the event, the British Contract Manufacturers and Packers Association is delighted that Making Pharmaceuticals is now in its fourth year, with the exhibition growing to more than 100 exhibitors.
Visitors looking to outsource their clinical trials, pharmaceutical manufacturing and packing will be able to meet BCMPA members Chester Medical, PCI Pharma Services, Quay Pharmaceuticals and Recipharm, and discuss their projects face to face. They can also visit Rodney Steel and Emma Verkaik on the BCMPA Stand (116) to discover how to find accredited outsourcing partners via the search facility on the association’s website, which has recently been updated to include mobile/tablet friendly versions. The trend to outsource is definitely on the up and Making Pharmaceuticals provides the ideal opportunity for visitors to explore the benefits of outsourcing with BCMPA members.
The event, which includes a superb seminar programme, has successfully filled a void in the UK’s pharmaceutical calendar, providing an excellent and cost-effective showcase for the industry. The expansion of the event and the relocation to the Ricoh Arena is testament to its success.
Technoprint is a specialist pharmaceutical leaflet provider
“Making Pharma is a perfect platform to showcase our quality and innovation,” explains MD and owner Alan Ryan. “We are very much looking forward to the opportunity to meet and talk to an array of pharmaceutical companies, and can’t wait to discuss and promote our unique mix of PS9000 accreditation and impressive service.”
“Many of our customers came to us initially with challenges and problems with their leaflet requirements. We work closely with them to ensure that their leaflets pack well and do not cause any costly issues,” he adds. “During the exhibition, we will be showing our PHARMALITE papers, which have been specifically developed for pharmaceutical use. We can print and fold 35 gsm paper, and hold both 45 and 60 gsm in stock as standard.
Our largest and newest folding machine can fold 18 times in one pass.”
Also on show will be the MULTIFLET leaflet, an innovation that can be used for multiple sections of a leaflet or for when several identical leaflets are needed in one pack. The MULTIFLET starts life as one sheet, then is cut during the folding process. This enables two, three or four leaflets to be created, with all parts guaranteed to be present.
The company’s MINUTAG leaflets can be as small 26 mm2 and still be secured with a tagsert. “We can actually fold down to 18 mm in width for when space for the leaflet is limited by carton size,” says Alan. “Our newest innovation is a tray that aids the smooth loading of leaflets into an automated machine. TECH-PACK reduces the time removing and disposing of plastic, so it has great environmental benefits as well as the obvious benefit to loading the machine more easily.” Visit Technoprint on stand 117 to discuss any leaflet issues or challenges.
Quotient Clinical, the early phase drug development services provider, has acquired QS Pharma, the contract development and manufacturing organisation (CDMO), based near Philadelphia, US, from Charles River Laboratories International. The acquisition increases Quotient’s footprint in the US and, combined with its recent acquisition of SeaView Research, the specialist clinical pharmacology business, paves the way for Quotient to replicate its Translational Pharmaceutics platform in America.
Founded in 2002, QS Pharma specialises in the formulation development and manufacturing of small molecule drug products, and is capable of supporting customer programmes through all stages of development and commercialisation. Of particular relevance is QS Pharma’s capability to work with high potency molecules, which is a fast-growing market need.
Mark Egerton, Chief Executive Officer, Quotient, said: “The acquisition of QS Pharma further supports our strategy in the US. Combined with the acquisition of SeaView, we have now increased the scale of the Quotient business to approximately 600 employees, with annualised revenues approaching $100 million. We have proven the advantages of Translational Pharmaceutics, and believe that there are strong synergies with the QS Pharma business. We remain focused on continuing to deliver drug development solutions that save our customers both time and money.”
Nutan Gangrade, Managing Director, QS Pharma, added: “We are delighted to join forces with Quotient. Translational Pharmaceutics represents a truly innovative solution that will synergise with our core formulation development and manufacturing services. We have grown our business successfully on the basis of quality and speed, and will continue to do so as part of Quotient.”
Custom Pharma Services is pleased to announce the start of building work on its £20 million Pharmaceutical Innovation Centre (PIC) in Moulsecoomb, UK. The Custom PIC will house the contract development, clinical and commercial manufacturing teams in a new, purpose-built facility. This investment is in addition to the previously announced expansion of its analytical laboratories and the ongoing project to introduce serialisation to Custom’s commercial packing lines.
The decision to expand Custom’s offer into commercial potent molecules has been led by client enquiries and a detailed assessment of the UKs pharmaceutical manufacturing environment. In the clinical arena, Custom is seeing an increase in the potency of molecules and, concurrently, a wish from pharmaceutical companies to switch from a simple “drug in capsule” formulation to a more commercially acceptable formulation as early as possible. Within the PIC, Custom is investing in both capsule and tableting capabilities for potent clinical development and commercial manufacturing. Custom has the capability to offer to clients a genuine choice for their solid phase product — from simple capsule formulations that will need refining during the clinical programme to a more complex formulation option, from first intent, that can ensure a smoother clinical and regulatory pathway.
The Custom PIC facility has been designed to be compliant with multiple regulatory agencies and will allow Custom Pharma Services to manufacture solid oral dose formulations of potent molecules — both for clinical and commercial products. The new facility will be available for development, clinical and potent commercial manufacturing by the end of 2017.