The cGMP-compliant equipment provides added value in Almac’s clinical manufacturing capabilities, strengthening the company’s focus on providing clients with a variety of high quality packaging solutions.  In a broader scope, it lends itself to strengthen Almac’s service portfolio that addresses the clinical packaging, labelling, and distribution needs of global clients.

Features of the TF3 include a 220mm x 290mm form area, colour vision system, automated seal registration, and a programmable punch station.  The machine is equipped with an automated feeder that can accommodate the input of up to 4 different products (tablets or capsules) simultaneously.  Capable of speeds averaging 50 indexes per minute, this machine provides convenient and efficient tool-less changeovers.

Almac evaluated a number of high-quality vendors when looking into the purchase of the new blistering equipment.  The TF3 was chosen based on its flexible and versatile nature and its ability to most suitably fulfil Almac’s need to expand to meet the growing needs of global clients.

“The purchase of the PharmaWorks TF3 machine will allow Almac to fulfil our customer’s needs by increasing our blistering capacity,” said Dan Megill, Director of Operations at Almac.  “This machine offers leading functionality and supplies Almac with a highly flexible format to support our various clients and their packaging needs.

PharmaWorks are at the forefront of forming technology and the support we have received from them has been tremendous.  We are pleased with this acquisition and expect it to contribute greatly to Almac’s overall productivity while enhancing our core services.”

Ben Brower, PharmaWorks VP, also commented “As our tag line on the TF3 brochure states – “No compromise: efficiency and flexibility across the entire spectrum of blisters”. I cannot think of a better summary of the TF3. We have included features and technology to solve many of the pharmaceutical industry’s blister production challenges. From our user friendly interface to our laser seal and punch registration features we feel the machine is state-of-the-art. We are proud to count Almac as a continued customer and partner in providing the highest quality in pharmaceutical blister production.  Almac will be able to offer its customers unparalleled and equal efficiency whether producing HUD type blisters or large BINGO type blisters.

For more information on Almac’s clinical trial supply service portfolio, contact clinicalservices@almacgroup.com. 

Notes to Editors

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.  The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

The versatile UPS 4 blister line will process solid oral dose products, providing primary packaging into a range of materials including PVC, PVC/PVDC, Aclar and Alu/Alu.  Complete with an integrated C2206 cartoner, the line will provide a highly efficient packaging solution with an output of up to 12,000 blisters per hour, in a wide range of blister sizes.

The line is capable of both multi-product blister processing and online blister printing (both flexographic and digital) addressing the need for enhanced patient compliance, whilst ensuring flexibility of supply.

Enhancing product compliance, the line will include a Total Quality Control Centre (TQCC) incorporating a checkweigher and integrated print and vision system for auto – rejection of incorrect print / serialisation data including 2D codes.

The blister line will complement the full suite of highly flexible and state of the art commercial packaging equipment already installed in the new Audubon facility.  Supporting high volume marketed products to niche/orphan drug launches, additional key technologies include bottling, walleting and vial labelling/packaging.

Geoff Sloan, VP Manufacturing Operations explained that the partnership with Uhlmann, one of the leading US Pharmaceutical equipment suppliers, was a natural choice.  “Uhlmann were able to provide us with a versatile, high-spec blistering line to match ourUSclient requirements for a high quality, flexible commercial packaging solution.”

Ralf Klotz, Regional Sales Manager, Uhlmann commented “The construction and installation of this equipment proved to be a great project. We are looking forward to a long term partnership with Almac as their US Operations continues to grow. The flexibility of this equipment certainly puts Almac in a position as a leader in contract blister packaging”.

For more information on Almac’s service capabilities, visit www.almacgroup.com/uspack.  Almac will be exhibiting at Interphex (booth 1109).

Notes to Editors

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.  The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland.US operations are based in Pennsylvania, North Carolina and California.

The Craigavon-based pharmaceutical development company collected the Excellence in Technology award at a ceremony held at the Ramada Plaza Hotel, Shaw’s Bridge, Belfast to reward the best of Northern Ireland’s business community across 12 categories.

Almac has developed new technology which sets it apart in a difficult chemical market which is under threat from Asia. Almac’s Sciences Business Unit has set up a dedicated group for discovering and implementing effective processes for biocatalysis – enzymes which effect desired chemical transformations.

The biocatalysis group has doubled since it was established in 2009 to become an integral part of the company. Almac’s growth in this area has been further enhanced by a £2.5m research and development investment, supported by INI, and the subsequent launch of a biocatalyst technology platform, SelectAZyme™ brand.

Almac is currently collaborating with institutions including Queen’s University Belfast and University College London in a bid to ultimately discover new catalysts with unique properties while providing industrial training opportunities for students and graduates.

The Almac team collected the award from Scott Kennedy, a director and head of the Intellectual Property and Technology team at category sponsor Cleaver Fulton Rankin Solicitors.

Stephen Barr, Managing Director of the Almac’s Sciences Business Unit, said: “Winning this award is recognition that we are at the forefront of technological advances in our field.

“Our unique technology is used in a range of applications from medicinal chemistry to the manufacture of specialist chemicals. It has enabled Almac to enter into complementary industries including flavour and fragrances and biofuel arenas.

“It has a positive environmental impact as it promotes the use of green, renewable clean catalysis and helps lower costs, reduce waste and increase productivity.”

Alastair Hamilton, chief executive of Invest NI, and a member of the Belfast Telegraph Business Awards judging panel said: “Companies which adopt and embrace technology as an integral part of their business model tend to be those which drive growth and success. Each of the shortlisted companies in this category has demonstrated excellence in technology in their own way. However, for its use of new technology to fuel its growth and become a world leader in the pharmaceutical and biotechnology sectors, the panel concluded that Almac is this year’s worthy winner.”

Brenda Morgan, Sales Manager Ireland at title sponsor bmi, added: ”Within the annual business calendar there is no other event to equal the impact of the Belfast Telegraph Business Awards.  The event provides the business community with the opportunity to share and celebrate the importance and impact of business excellence.

“This year’s awards ceremony highlighted that Northern Ireland is in business, not just business as usual, but business that is competitive and competing on a world stage.  The 2012 winners reflect the range and diversity of outstanding business success both at home and abroad.  There is a very clear message – the Northern Ireland business community are alive and well and are succeeding in one of the most difficult economic climates for many years.”

Notes to Editors

About Almac

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.  The company employs over 3,300 and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com

Almac launched its Six Sigma program in 2011 with the training of its entire Clinical Technologies’ leadership team and selected staff from each functional discipline in Lean Six Sigma methodologies.  This training helped prepare the organization to effectively leverage the team of twenty Six Sigma experts who are currently leading strategically-selected business improvement projects. By adhering to a disciplined, fact-based process excellence methodology, Almac expects its Six Sigma program to deliver increased value to clients, employees and sites, all of whom will benefit from the technology and process improvements currently underway.

Jim Murphy, President of Almac’s Clinical Technologies’ Business Unit comments: “Since our founding, Clinical Technologies has nurtured a learning culture that is focused on customer satisfaction, innovation and continuous improvement. A significant part of our corporate culture involves using metrics and data to make business decisions; this dovetails perfectly with the Six Sigma methodology, a systematic information-driven methodology for improving business performance by reducing, if not eliminating, product and process deficiencies and variation. With Six Sigma in our continuous improvement toolkit, Almac will drive efficiencies that we can pass on to our clients, all of whom are striving to increase the productivity of their R&D efforts.”

Almac selected the Juran Institute, an internationally recognized leader in the field of quality management, as its Lean Six Sigma training and deployment partner. Juran’s Lean Six Sigma program was especially attractive to Almac because it can be implemented flexibly and quickly to achieve performance breakthroughs and sustainable business results. Todd Kole, Almac’s Vice President of Clinical Project Services department comments on Almac’s selection of Juran: “Almac selected Juran as a partner in its Six Sigma training because of its reputation as one of the world’s leaders in both Six Sigma and Lean methodologies. More importantly, Juran took the time to understand Almac’s business, clients and industry and put together a tailored program that would help Almac achieve its strategic and operational goals.”

Notes to Editors

About Almac

Almac’s Clinical Technologies Business Unit specializes in interactive technology and service solutions to increase the quality and efficiency of clinical trials. Solutions include Interactive Voice and Web Response Systems (IXRS^®) for patient randomization and drug assignment, patient and clinical supplies management, electronic-patient-reported-outcomes data collection, patient compliance and Web drug reconciliation. Almac’s technologies have been deployed in over 1800 clinical trials, incorporating over 1.7 million patients in over 80 countries and more than 50 languages.

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com

About Juran Institute

In 1979, Dr. Joseph M. Juran founded Juran Institute, Inc., an organization aimed at providing research and pragmatic solutions to enable organizations from any industry to learn the tools and techniques for managing quality and performance excellence. Building upon Dr. Juran’s foundation, they now provide a number of services to help clients in all industries. Juran is known worldwide for research, consulting, and training that enables organizations to increase product and service quality, streamline business processes, reduce costs, and heighten their competitive edge.

Juran’s mission is to create value for society and customers through superior quality and sustainable results. Their vision is to be recognized by customers as the best source for achieving that value.

Almac today announced that it has signed an exclusive global distribution deal with Affymetrix, Inc.  enabling them to directly sell Almac’s proprietary Xcel™ array for biomarker discovery, development and delivery worldwide.

 Almac’s Xcel™ array is a high density transcriptome-based microarray that has been optimised for the discovery and development of biomarkers from formalin fixed paraffin embedded (FFPE) tissue. Designed by Almac and built on the industry standard Affymetrix’ GeneChip^® platform, the content of Xcel™ array has been derived from high quality sequence data, as well as mining public gene expression and sequence databases.

The array contains more content than all currently available 3` microarrays, with over 97,000 transcripts including antisense, non-coding transcripts and significant unique content. Working with FFPE enables the potential to profile retrospective samples in tissue banks, a highly valuable resource.

Standard practice is to collect patient samples and store in FFPE and the ability to unlock information from these samples will rapidly increase the discovery opportunities in personalised medicine. Further to this, translating these discoveries into the clinic on an FFPE platform will drive the commercialisation of these biomarkers.

The substantial content on Almac’s Xcel™ array ensures that the platform technology is ideally suited for research in cross-disease areas, a notable advantage to pharmaceutical companies. It has also been designed to include all of the content from the Affymetrix’ GeneChip^® Human Genome U133 Plus 2.0 Array, enabling simple transfer and continuation of existing research.

Kevin Cannon, PhD, Expression Business Lead at Affymetrix commented:

“Almac’s Xcel™ array with its superior design and content derived from multiple cancer types provides an ideal microarray for gene expression profiling from FFPE tissues, unlocking previously inaccessible genetic content for translational research. Researchers now have the ability to carry out retrospective studies for discovery and validation of gene expression biomarkers and translate them into clinical practices. This array represents a significant technology advancement, and combined with Genisphere’s Sensation™ reagents address a much needed FFPE workflow solution for gene expression profiling and biomarker discovery.”

Vice President of Business Development of Almac’s Diagnostics Business Unit, Michael Sloan commented:

“We are very pleased to have entered into this agreement with Affymetrix. The Xcel™ array has proven to be extremely useful in our hands for biomarker discovery both for our in-house R&D and for our clients. This distribution deal with Affymetrix will enable more researchers to see the benefit of the platform.”

Affymetrix will officially launch the Almac Xcel™ array at this year’s AACR annual meeting in Chicago.

Ends….

Notes to Editors

About Almac

Almac’s Diagnostics business unit is focused on the discovery and development of biomarkers. It utilises its proprietary technology, extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.  The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com

About Affymetrix     

Affymetrix technology is used by the world’s top pharmaceutical, diagnostic, and biotechnology companies, as well as leading academic, government, and non-profit research institutes. More than 25,000 peer-reviewed papers have been published using the technology. Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Santa Clara, Cleveland, Ohio, and Singapore. The company has about 900 employees worldwide and maintains sales and distribution operations across Europe, Asia, and Latin America. For more information about Affymetrix, please visit http://www.affymetrix.com.

Robert Dunlop, Managing Director at Almac commented: “The workshops are designed to promote learning and encourage dialogue amongst members of the clinical trial profession. Attendees can share experiences, discuss common challenges, and ultimately take away with them methods for overall success in clinical trials.“

As with previous workshops delivered by Almac, the content demonstrates how the integrated service offerings from the Almac Group deliver a more streamlined supply chain network in an industry wherein time and resources are limited.

The venues and dates for this year’s workshops can be found below.

US dates / locations

Location:         Durham, NC

Date/ time:      Tuesday, 24- April 11am-2pm

Venue:             The Mez, 5410 Page Road, Durham, NC

Location:         Bridgewater, NJ

Date/ time:     Thursday, 26 – April 11am-2pm

Venue:             Maggiano’s, 600 Commons Way, Bridgewater, NJ

Location:         Boston, MA

Date/time:       Tuesday, 1 – May 11am-2pm

Venue:             Legal Sea Foods, 5 Cambridge Center, Cambridge, Massachusetts

Location:         San Francisco, CA            

Date/ time:      Thursday, 3 – May 11am-2pm

Venue:             Medallion Steakhouse, 1095 Rollins Road Burlingame,CA94010

EU dates / locations

Location:         Cambridge UK

Date/ time:      3rd May -9:30 am- 2pm

Venue:             24 Cambridge Science Park, Milton Road , Cambridge CB4 0FN

Location:         Copenhagen

Date/ time:      8th May -9:30am – 2pm

Venue:             Scandic Hotel Raadhuspladsen 57 1550 Copenhagen

Location:         Basel

Date/ time:      10th May -9:30 am – 2pm

Venue:             Swissôtel Le Plaza Basel Messeplatz 25 4005 Basel  Switzerland

To register for an event near you, visit the registration sites here. Seats are limited, and registration is required to secure your place. For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com

Notes to Editors

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.  The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania,North Carolina and California.

The Craigavon-based pharmaceutical development company has said it will create eight scientific apprenticeships for SRC students, starting in September this year.

The announcement was made at the opening of a new state-of-the-art science laboratory at the Portadown campus of the College and will see Almac providing two year apprenticeships to16 to 24 year olds studying NVQ laboratory technician courses to Level 3.

Stephen Barr, Managing Director of Almac Sciences, who officially opened the new science laboratory, said: “Almac is committed to the development of effective partnerships withNorthern Ireland’s schools, colleges and universities and working with SRC on this initiative to train local young people for science careers is a great example of this.

“For eight young people September will mark the start of an exciting two years which will see them gain extremely valuable experience both from SRC staff in these wonderful new labs in Portadown and on the job training with our scientists at Almac.

“We believe initiatives like this are vital to ensure our workforce has the right skills for the future as we continue to expand our services to companies across the world in the pharmaceutical and biotech sectors.”

Science has not been studied at the Portadown Campus of SRC for over a decade and the new lab will also see the introduction of science courses ranging from adult returner programmes to degree level courses in applied science.

Brian Doran, Director of Southern Regional College, commented: “Our curriculum in the next five years will be aligned to industrial requirements in the greater Craigavon area.

“We are delighted to be working with Almac, one of the leading pharmaceutical companies in the world, in delivering NVQ laboratory technician courses to Level 3 as part of the apprenticeship framework.

“This marks a significant milestone for the future delivery of science programmes in the greater Craigavon area and we look forward to taking forward our plans for the future development of science in our Portadown Campus.”

Anyone interested in finding out more about how to apply for the apprenticeships should go to www.src.ac.uk

Notes to Editors

About Almac Group

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, and IXRS® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,300 and is headquartered in Craigavon, Northern Ireland.USoperations are based in Pennsylvania, North Carolina and California.

About SRC

Southern Regional Collegeis the largest further and higher Education College outside ofBelfastinNorthern Ireland. With a total of six campuses across the counties ofArmaghand Down and covering four district councils, the College offers first class education and an exciting learning environment for further and higher education.

At further education level, the College offers courses from BTEC Level 1 Diplomas, through NVQs, National Diplomas and A levels. Many of these are aimed at the full time market although many of these courses are available on a part time basis also. The College also offers Apprenticeship Training programmes where students can learn valuable trades to take into the workplace.

The College takes enrolments of approximately 35,000 students each year and employs over 1,100 staff.

aXcess™ provides a unique alternative to using paper based or manual systems to automate patient randomization and supply chain management for small to mid sized studies. Almac’s intuitive and user-friendly aXcess™ system gives clients the full benefit of a web-based randomization system, including state of the art reporting functionalities, shorter timelines for system build, and a price point to fit tight study budgets.

“The new IVR/IWR system, aXcess™, coupled with our clinical packaging and distribution bundle gives companies who would typically utilize a paper based approach to randomization and supply chain management an alternative option. This option more effectively manages the trials our clients are conducting at a cost that works within their budgetary restrictions”, says Donna Christopher, VP of Operations.

This recently enhanced IVR/IWR system was developed to give our clients the features and functionalities they are looking for in a web-based system for the small to mid-sized studies they are conducting.

For further information on aXcess™ or to request a demo please click here.

Notes to Editors

About Almac

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, and IXRS® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland.US operations are based inPennsylvania, North Carolina and California.

Bringing more than 30 years’ commercial packaging experience from its MHRA/FDA approved UK facilities and having established a reputation for delivering high quality, reliable and cost-effective commercial packaging solutions, clients can now leverage this expertise from a local US based operation.

David Downey, VP Commercial Operations said, “Addressing the communicated needs of our Clients, we have taken the strategic step of establishing a US based operation for commercial packaging services. For many years we have been bulk manufacturing and packaging US products from our UK facility. With the addition of the Audubon facility, we will now be able to offer these packaging services local to the US market place, providing cost saving and mitigating supply risks”.

Following completion of the evaluation and feasibility design work, refurbishment of the facility has commenced and systems handover is scheduled for Fall 2012.

Upon FDA approval, Almac will offer commercial primary and secondary packaging of tablets and capsules into bottles, blisters, wallets and hospital unit dose formats along with secondary labeling and packaging of biopharmaceutical presentations such as vials and ampoules. Complementing these services are dedicated teams in pack design & artwork management and in-house tooling fabrication. Significant warehousing in ambient, refrigerated and controlled drug storage completes the services offering. 

Graeme McBurney, President & Managing Director, Almac Pharma Services said, “We are delighted to be able to invest in new facilities and establish operations in the US.  With the alignment of our packaging processes at both our UK and US sites, we offer the highest levels of customer service and continuity of supply, through a flexible and quality lead operation”.

For more information on Almac’s service capabilities, visit www.almacgroup.com/uspack.

Notes to Editors

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.  The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

The acquisition gives added value to the already impressive array of over-encapsulation capabilities offered by the global service provider as part of a complete clinical supply chain management portfolio.  The Bosch cGMP-compliant system is able to produce 42,000 capsules per hour compared to the 2,700-4,500 output of Almac’s current machine in the United States.  Further capabilities of the new equipment include powder, pellet, tablet, and placebo fill as well as multi-fill.  The addition now creates balance between Almac’s EU and US sites by providing the same capacity to handle large and smaller scale projects simultaneously.

“This level of investment in encapsulation technology allows us to expand our capacity within our core services and shows our commitment to our clients,” says Dan Megill, Director of Operations at Almac.  “Bosch was chosen by Almac because they are a leader in capsule filling and weighing equipment with a variety of options.  We are extremely pleased with this acquisition and expect it to contribute greatly to Almac’s overall productivity.”

The KKE 1700 checkweighing machinery strengthens the acquisition by offering comprehensive documentation of the production batches, optimal pharmaceutical security, and a high degree of productivity.

The GKF 702 with its upgraded performance builds on the success of the previous GKF 701 model and the machine offers many advantages for research and development. The machine’s modular design offers the possibility to retrofit any future filling needs and all new filling stations currently in development will be compatible with this machine type.

For more information on Almac’s service capabilities, visit www.almacgroup.com. Further information about Bosch Packaging Technology is available online at www.bosch.com and www.bosch-press.com.

Notes to Editors

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.  The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania,North Carolina and California.