Featured Image: Piramal's Coldstream Laboratories uses both a LyoStar™II and LyoStar™3 R&D freeze dryer to develop lyophilized formulations that are based on robust and cost-efficient processes. The company's rapid-response formulation team has experience in screening effective combinations of solvents (both aqueous and non-aqueous), buffers, bulking agents, and lyo/cryo-protectants. This experience leads to a robust final product that has low residual moisture/solvent, forms a solid and attractive cake, reconstitutes readily and completely, and resists physical and chemical degradation. Using the company's lab-scale freeze dryers, the formulation team develops compounding processes and lyophilization cycles that can be successfully and readily transferred to our cGMP production scale freeze dryer. The development team oversees the scale-up of any process developed in the company's laboratories to ensure a seamless transition from lab-scale to manufacturing. Formulation experts work first-hand with the production team to effect a smooth and efficient transition to plant-scale operation. Courtesy: © 2014 Coldstream Laboratories/Piramal Pharma Solutions. Used with permission.

Piramal Pharma Solutions has confirmed that it is planning an expansion Coldstream Laboratories, its sterile injectable manufacturer the company purchased in early 2015. The the US$ 10 million expansion is expected to add 40 jobs at Piramal’s Coldstream Research Campus location in Lexington, KY. As part of the planned expansion Piramal is expected to add specialist containment and chemical handling capabilities, allowing the ability to handle high potency APIs and develop and deliver novel drug products.

Kentucky’s newly elected Governor, Matthew Griswold “Matt” Bevin and Lexington Mayor Jim Gray announced the planned expansion and the expected economic impact on the area.

Strengthening Industry
“Growth in private-sector employment—particularly high-paying, skilled jobs like these—moves Kentucky forward on the national and global level,” Bevin said. “I congratulate and thank Piramal Pharma Solutions and Coldstream for this investment to further strengthen Kentucky’s pharmaceutical industry. We are excited by this opportunity to become an increasingly important part of Piramal’s global footprint and look forward to many years of partnership with them.”

Lonza
ADC Bio
MabPlex
 

“Our state’s institutions are training biomedical scientists including pharmacologists, laboratory technicians and population researchers,” Senator Ralph Alvarado M.D., of Winchester, Kentucky, added. “The continued growth and success of pharmaceutical developers and innovators such as Coldstream Labs not only improves the Bluegrass region’s industry but also helps secure a source of employment for Kentucky’s talented graduates,” Alvarado said.

Coldstream Labs started in 1991 as the Center for Pharmaceutical Science & Technology, a unit of the University of Kentucky College of Pharmacy. It completed more than 200 development projects that led to clinical trials. In 2007, the college spun off Coldstream Labs as a private company owned by the University of Kentucky Research Foundation.

Technical expertise and expansion
As a separate independent business, Coldstream Labs gained the ability and technical expertise to manufacture liquid and freeze-dried injectable products. In January 2015, the Research Foundation sold Coldstream Labs to Piramal Pharma Solutions, a global leader in pharmaceutical contract services, and the flagship division of the Mumbai, India-based Piramal Group for a total of US$ 30.65 million.

The Piramal Group operates in more than 30 countries with a presence in 100-plus markets around the world. Piramal Pharma Solutions, a division of Piramal’s flagship company Piramal Enterprises Limited, also maintains U.S. operations in Bethlehem, Pa. in addition to Coldstream Labs. As part of Piramal, Coldstream Labs can access the financial resources needed to expand its facilities and meet its customers’ needs.

“The excellence of the University of Kentucky Pharmacy program and the brainpower it has brought to Lexington are creating good jobs for our citizens,” Lexington’s Mayor Gray noted. “These are homegrown jobs that build on our growing reputation in the pharmaceutical industry.”

Tax incentives
To encourage the investment and job growth in Lexington, the Kentucky Economic Development Finance Authority (KEDFA) preliminarily approved the company for tax incentives up to $800,000 through the Kentucky Business Investment program. The performance-based incentive allows a company to keep a portion of its investment over the agreement term through corporate income tax credits and wage assessments by meeting job and investment targets.

Photo 1.0: Vivek Sharma, CEO of Piramal Pharma Solutions: “The Coldstream Labs acquisition helped augment our service offerings to potential partners, while also allowing Piramal to participate in the growing injectable segment. Piramal Pharma Solutions now offers an end to end suite of high quality services to our partners, and is well positioned as one of the global leaders in contract manufacturing.” Courtesy: © Piramal Pharma Solutions. Used with permission.

KEDFA also gave Coldstream Labs preliminary approval for up to $140,000 in tax incentives through the Kentucky Enterprise Initiative Act (KEIA). KEIA allows approved companies to recoup Kentucky sales and use tax on construction costs, building fixtures, equipment used in research and development and electronic processing.

Coldstream Labs can receive resources from the Kentucky Skills Network. Through the Kentucky Skills Network, companies are eligible to receive no-cost recruitment and job placement services, reduced-cost customized training and job training incentives. Last year, the Kentucky Skills Network trained more than 84,000 employees from more than 5,600 Kentucky companies.

Growth Plan
Piramal confirmed that the planned investment fits the company’s strategic growth plan for its antibody-drug conjugate business. The Coldstream Laboratory facility allows clients developing ADCs to forward integrated and address their fill-finish needs.

According to William “Bill” Wedlake, president, Formulations & Antibody Drug Conjugates (ADC), Piramal Pharma Solutions, the investment aligns well with Piramal’s long term growth strategy.

“In addition to developing new clients, the Kentucky facility also allows our current ADC clients to forward integrate seamlessly and address their fill-finish needs,” Wedlake said. “As oncology becomes key in our collaborators portfolio, our ability to handle high potency APIs, develop and deliver high quality, robust, cost effective drug product solutions becomes a key differentiator. I am optimistic that the Kentucky site, will help us achieve that objective.”

The project is expected to help the Lexington facility grow into a significant player in the contract manufacturing market for injectable pharmaceuticals.

“The Coldstream Labs acquisition helped augment our service offerings to potential partners, while also allowing Piramal to participate in the growing injectable segment. Piramal Pharma Solutions now offers an end to end suite of high quality services to our partners, and is well positioned as one of the global leaders in contract manufacturing. Since our initial investment the Kentucky site has demonstrated both leadership and growth, and we are pleased to announce this subsequent phase of investment to enhance capability and capacity. We appreciate the active support from the State of Kentucky, the local Government, and most importantly, the community, as we continue our growth plans in Lexington,” Vivek Sharma, Chief Executive Office of Piramal Pharma Solutions, concluded.


Be a part of a community of ADC professionals and businesses. Share your expertise, discover new solutions, network with peers and grow your business. Become a member of the ADC Directory from the publishers of ADC Review. Join today!