Kindeva Drug Delivery (Kindeva), a prominent player in drug and medical device combination products globally, has unveiled the expansion of its analytical services, establishing a new global business unit. This unit is dedicated to providing integrated and standalone analytical support for the pharmaceutical, biopharmaceutical, and medical technology sectors. With over half a century of experience, Kindeva has garnered extensive knowledge in the development of inhaled, injectable, and transdermal drug delivery solutions, maintaining cGMP-compliant commercial delivery. The company has also demonstrated strong competencies in cGMP analytics to support its product development and supply partners.
To bolster Kindeva’s global presence in analytical services, its newly inaugurated 2,970-square-meter state-of-the-art laboratory centers in Woodbury, Minnesota, will function as a central hub for its expanded array of independent analytical services. Dave Stevens, Global Chief Commercial Officer at Kindeva, highlighted, ‘Offering extensive analytical testing capabilities independently to the broader pharmaceutical and medical device industries is a significant move to position Kindeva as a global contract analytics, development, and manufacturing company.’ Stevens also discussed the company’s upcoming plans, stating, ‘In 2024, we will introduce industrial solutions crucially needed in many areas to the market. This includes the launch of a state-of-the-art sterile injectables facility in Bridgeton, Missouri, capable of producing over 100 million vials, cartridges, and syringes. Additionally, our first GMP-enabled 152a environmentally friendly propellants manufacturing capacity in Loughborough, UK, will commence operations. Strengthening analytical capabilities underscores our commitment to being a comprehensive service partner and a leader in the CRO/CDMO industry, furthering the safety and effectiveness goals of innovators.’
Kindeva’s expanded analytical services encompass testing for extractables and leachables, elemental contaminants, medical devices, and container closure integrity. The company will adhere to the new USP <1207> container closure integrity testing standards, led by Michael Dominguez, the new Manager of Container Closure Integrity (CCI) and Medical Device Testing. Dominguez brings profound expertise in medical device performance and functional testing, including deterministic CCI methods such as high voltage leak detection, vacuum decay, laser headspace analysis, and residual seal force testing. Dan Dohmeier will lead Kindeva’s extractables, leachables, and elemental impurities testing business, ensuring adherence to the ICH Q3D elemental impurities guideline. With over 60 years of combined experience, the Dohmeier team specializes in developing, validating, and testing extractables and leachables methods to meet customer testing requirements. Both Dominguez and Dohmeier will be available to engage with attendees at Kindeva’s booth 972 during the upcoming MD&M West event in Anaheim, California, from February 6-8, 2024.
