30 Pharmaceutical Contract Manufacturing Innovators to Watch in 2013
The list of winners from Life Science Leader's 2012 CMO Leadership Awards, based on research by Nice Insight, provides a good idea of which pharmaceutical contract manufacturers are set to make headlines this year.
Here's a rundown of the winning firms:
The Northern Ireland-based firm is going from strength to strength, having recently launched its US packaging operations following the successful inspection of its new Pennsylvania facility by the Food and Drug Administration. "The fact that over 95 per cent of our business is repeat is genuine evidence of our success," said chief executive Alan Armstrong.
This unit of Baxter International has a strong reputation for its scientific expertise, contract manufacturing capabilities and packaging solutions. "We are able to offer key capabilities to align with our clients' commercialization objectives and our mutual goal of moving patient care forward," commented global franchise head Robert Felicelli.
With manufacturing sites in Copenhagen and Seattle, CMC has been growing steadily since it was founded in 2001 and now employs more than 350 people. "Our expertise in cGMP process development and manufacturing puts our clients' projects in an optimal position to succeed," said chief executive Claes Glassell.
Active in its current incarnation since 2007, Coldstream is a spin-off from the University of Kentucky's College of Pharmacy in Lexington. It specialises in the manufacture of sterile injectables. President and chief executive Larry Kranking said the company is "constantly improving with the addition of state-of-the-art equipment and the expansion of physical production areas and laboratory space".
Cory Lewis, vice president of business development and marketing at Cook Pharmica, said the company's "flexible infrastructure" is one of the main reasons for its success. Based in Indiana, this subsidiary of Cook Group offers its clients a one-location model for development, clinical or commercial cell culture manufacturing, formulation, parenteral product manufacturing and secondary packaging.
Dalton was founded in 1986 and offers a number of services to the world's pharmaceutical and research communities from its Toronto base, including cGMP manufacturing of solid dosage forms and aseptic filling services. "Dalton's role is to enhance the success of our customers by delivering cutting edge science and exceptional customer service," commented Peter Pekos, president and chief executive.
General manager Karen Yu said Dow Pharmaceutical Services was "honored to be recognised for our efforts and to be highlighted as a premier semi-solid and liquid product development company". According to the California-based company, Almost one-third of all new drug applications for prescription topical dermatological products approved by the FDA in the last seven years have been developed at Dow.
DPT is a contract development and manufacturing organisation that specialises in semi-solids and liquids, operating from its Centers of Excellence in Texas and New Jersey. "Our vision emphasizes innovation, high-quality service and the best technology," explained Paul Johnson, DPT's group president and chief operating officer.
DSM operates five business units that encompass biologics, biosolutions, exclusive synthesis, pharma chemicals and pharma dosage forms. Chief executive Alexander Wessels said the company was "honored to receive a CMO Leadership Award based on the fact that the awards represent the opinions of the customer, pharmaceutical and biopharmaceutical companies who are using our services".
Based in northern Italy, Flamma also has a manufacturing facility in China. Its core work includes the manufacture of chiral materials (high-value amino acids) as starting materials or key intermediates for pharmaceutical and biotech clients. Kenneth Drew, the firm's director of US sales and business development, said the company deserves its reputation for innovation. Flamma consistently works with our customers by treating them as if they are family," he added.
"Quality underpins everything we do to ensure patient safety and this is exemplified by our successful inspection history at both our US and UK sites," said president Stephen Spearman after the firm was announced as a CMO Leadership Awards winner. FujiFilm Diosynth, which has facilities in North Carolina and Billingham in the UK, specialises in the development and manufacture of recombinant proteins, vaccines and monoclonal antibodies.
Based in St Louis, Gallus operates a facility formerly owned by the Centocor division of Johnson & Johnson. President and chief executive Mark Gallus said the company's productivity "is epitomised by its ten-year history of commercial manufacturing, with over 200 commercial batches of product manufactured for 75 countries".
Goodwin Biotechnology is part of the Wallace Pharmaceuticals group and specialises in the manufacture of monoclonal antibodies, recombinant proteins and vaccines. It significantly expanded its manufacturing capabilities back in 2008. "Our unique approach helps ensure that we meet and exceed client expectations on every project," said interim chief executive Bansi Bhan.
Haupt Pharma is one of the biggest European companies in the pharmaceutical contract manufacturing sector. Chief operating officer Dr Karl Heinz Brucher said the firm operates a dedicated production area to ensure the safety of its products and its employees. "Under the closed and high-containment principle, processing of highly efficient active ingredients is performed in a closed system," he explained.
Founded in 2007, this New Jersey-based company specialises in the manufacture of sterile injectable products for clinical settings. In December last year, it was acquired by an affiliate of private equity firm Warburg Pincus and announced plans to expand its development pipeline. "JHP's established infrastructure and deep experience allow us to focus on innovative approaches to meet complex manufacturing needs," said chief executive Stuart Hinchen.
Headquartered in Bangalore, Kemwell has been operating since 1980 and was named India's best CMO in 2010. "For over 30 years, Kemwell has maintained a strong history of manufacturing quality, flexibility and customer service," commented Anurag Bagaria, the firm's managing director and chief executive.
Michael Griffith, chief executive of Laureate Biopharma, has hailed the company's "30 years of innovation in biopharmaceutical development and processing". Based at Princeton in New Jersey, the firm's portfolio of services includes process development and cGMP production of therapeutic proteins including monoclonal antibodies and Fc-fusion proteins.
With a history dating back to the 1880s, Norwich Pharmaceuticals is a provider of contract development and manufacturing services for prescription and over-the-counter drugs. "Patients put trust into our customer's products, and Norwich's 125-year history of quality and compliance provides a foundation for that trust," said company president Terry Novak.
"Innovative technical and scientific solutions, high quality and commitment to excellence is at the foundation of our work," commented Patheon chief executive Jim Mullen. The company boasts a network of 14 contract manufacturing facilities and 12 development centres spread across North America and Europe.
Pfizer CentreSource (PCS), a leading supplier of steroid products, is a separate operating unit within the US pharmaceutical giant. Its other recent successes include being named company of the year by the International Society for Pharmaceutical Engineering in 2011. "PCS is pleased to be recognized by Life Science Leader for our operational excellence in the areas of reliability, innovation, productivity, and regulatory," said Cristin Grove, director of contract manufacturing at PCS.
This US provider of contract manufacturing and packaging services, which runs facilities in Georgia and Missouri, has an excellent reputation acquired over more than 40 years in the industry. "Our experienced quality and regulatory personnel address a broad range of domestic and international regulatory environments," explained Pharma Tech president Carl Oberg.
San Diego firm Pharmatek offers support services that include compound selection, analytical development, preformulation testing, GMP manufacturing and high-potent and cytotoxic development and manufacturing. President Timothy Scott said: "While the business of pharma is ever-changing, the focus on quality is the undeniable core of success."
RohnerChem is an established Swiss company that offers custom manufacturing services, focusing on the development, upscaling and production of complex molecules. "RohnerChem is very proud to be rated so positively by our valued customers," said chief executive Dr Thomas Rosatzin.
SAFC is one of the four business divisions that make up the Sigma-Aldrich Corporation. It produces specialty chemicals and biologics for life sciences and high technology commercial applications. "As a CMO, SAFC aims to be the supplier of choice in the market. Reliability, innovation, productivity, and regulatory are more than words to our customers," commented Deborah Slagle, vice president of marketing and research and development at SAFC.
According to Sandoz, its portfolio of roughly 1,000 molecules is now available to more than 90 per cent of the world's population. The company is the generic pharmaceuticals unit of Novartis. "Central to our success are our talented people who take a collaborative approach with our customers by offering end-to end support," said Friedrich Nachtmann and Gerhard Santer, Sandoz's head of biotech corporations and head of global development and strategy.
Senn chief executive Carlo Hachler said his company is "committed to continuous innovation and quality excellence". Based in Switzerland with a US base in San Francisco, the firm has manufacturing expertise in the areas of peptides, amino acid derivatives, carbohydrates, small molecules, complex organic molecules and functionalized polymers.
Siegfried, another Swiss firm, has development and production facilities in its native country, Malta and the US. It is currently focusing on expansion in Asia. "Finding the right outsourcing relationship is critical for pharmaceutical companies today. At Siegfried we share their belief in high quality, innovation, productivity and compliance," commented Dr Rudolf Hanko, chief executive.
Therapure's operations are focused on the development, manufacture, purification and packaging of rare and complex biotherapeutics.??The Canadian company announced the opening of its custom biologics manufacturing wing earlier this month. Upon receiving the award, chief executive Nick Green said: "I would like to take this opportunity to thank all the employees of Therapure, whose daily contributions and diligence is the driving force behind our company's success."
Uman Pharma is also based in Canada, where it makes generic injectable pharmaceutical products, as well as providing contract marketing services. It is a relative newcomer to the industry, having only started work in 2008. "As a young company, we are extremely proud of our accomplishments to date and our mission has always been to provide excellence in both products and services," commented chief executive Sylvain Duvernay.
Jim Gregory, chief operating officer, claimed the key to Baltimore-based UPM's success is a "lean and flat corporate structure" that means every department has an influence on daily production decisions. "Keeping business in this highly competitive industry is about producing results for our clients," he added.
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