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, a Contract Development and Manufacturing Organization (CDMO), confirmed the Grand Opening of a area of it’s Riverview facility site dedicated to the production of high potency active pharmaceutical ingredients (HPAPIs) with low Occupational Exposure Levels (OELs).

The company’s total investment to upgrade the site was approximately US $10 million.

This includes the new QC/analytical lab and two kilo-labs, as well as a doubling of the office space, which was needed to support the dramatic growth at the Riverview site. Local dignitaries participated in the event, including Riverview Mayor Andrew Swift, Wayne County Executive Warren C. Evans and other officials representing the City of Riverview, Wayne County and Michigan Economic Development Corporation (MEDC).

Representatives of Piramal Pharma Solutions and local dignitaries at grand opening of the company’s new facility which is designed to offer manufacturing capabilities for high potency active pharmaceutical ingredients (HPAPIs) with low Occupational Exposure Levels (OELs).

To date, the Riverview site has had the containment capability and engineering controls to safely handle HPAPIs with OELs down to 1mcg/m3, at scales ranging from grams to ~250 kilos. The new wing, which consists of two kilo-labs and a QC/analytical lab, brings more to the table. It was designed with the required engineering controls and containment solutions to handle HPAPIs with OELs <1mcg/m3 and as low as ~20ng/m3. Materials will primarily be produced in this new wing at kilo-lab scales; lots of <5 kilos can be produced in this new state-of-the-art facility.

“We are one of only a few companies in the contract development and manufacturing market that have the capability to produce HPAPIs at such low OELs. It’s another example of how we remain committed to partnering with our customers to serve the patient community and reduce the burden of disease,” Vivek Sharma, Chief Executive Officer of Piramal Pharma Solutions

Vivek Sharma, Chief Executive Officer of Piramal Pharma Solutions: “We are one of only a few companies in the contract development and manufacturing market that have the capability to produce HPAPIs at such low OELs….”

Operational Change
Historically, the site operated as one shift, five days a week. Today, the site operates twelve hours a day, seven days a week, and is headed towards being a full 24/7 site. The Riverview site expansion also provides significant benefits to the local economy, including the addition of new high-tech jobs. The local staff has increased from 80 to 127 people, with a projected total of approximately 150 employees in the near future. This includes high-tech staffing of Ph.D and BS degreed scientists, plus manufacturing operators and other skilled workers.

“This new, enhanced capability opens the site up to a new base of customers, including the antibody-drug conjugate (ADC) market. We are equipped to offer ADC customers a seamless end-to-end solution, since we can develop the HPAPI payloads and linkers here in Riverview, send them to our site in Scotland for the antibody conjugation, then back to our Lexington, Kentucky site for sterile fill and finish,” noted Vince Ammoscato, Vice President and Riverview Site Head.

Antibody-drug Conjugates
The facility upgrade offers Piramal the ability to offer a fully integrated solution for the development of antibody-drug conjugates, which includes proof-of-concept studies to conjugation development, clinical and commercial ADC GMP batch manufacturing and fill/finish. This, according to Ammoscato, represents a significant strategic advantage for the company.

With additional real estate available on the site for added capacity and new capability enhancements to match the market needs of the pharmaceutical industry, Ammoscato mentioned that more expansions are forthcoming.