Analytical Lab Group
Building Innovative Testing Solutions

Nearly a year has passed since the pandemic took over the world, but the global healthcare sector is still struggling to stop the spread of the virus. To assist in this effort, pharmaceutical leaders are accelerating research and development efforts to bring out new vaccines and therapeutics earlier, and companies in critical infrastructure sectors are bolstering workforce safety and enhancing their compliance adherence. However, when it comes to ensuring the required effectiveness of the drug while also complying with stringent regulations, the drug development and ultimate distribution process often can become lengthy.

As a result, the ongoing challenge for pharma organizations is to improve the effectiveness of essential precautionary safety measures, ensuring and monitoring the existence of adequate cleaning and disinfection practices, and securing sound and reliable relationships with contract service laboratories to ensure accurate and quick release of manufactured drug products to market.

For many, the answer is Analytical Lab Group (ALG), which provides high quality and reliable contract laboratory services to help pharmaceutical organizations market high-quality products quickly and seamlessly.

What is ALG’s Secret?

The heart of ALG’s success lies in its technical regulatory and scientific expertise, combined with well-equipped laboratories. ALG has functioned at nearly 100% capacity throughout the pandemic, providing clients with uninterrupted access to cutting-edge contract laboratory testing services. With an appropriate mission statement – Helping Protect Life^® – ALG is amplifying its efforts in conjunction with key pharmaceutical organizations in the ongoing fight against COVID-19.

Testing finished drug products is extremely important to ensure drugs delivered to patients are free from contamination. “The role we play in Helping Protect Life^® is to ensure that proper testing occurs to confirm that products are free from the presence of contamination,” said Alan Roth, ALG CEO.

To this end, ALG has implemented robust precautionary infection prevention and hygiene enhancement practices across all of its sites. These measures are particularly designed to safeguard essential testing services from contamination and thereby reduce the chances of any delay in testing. This approach makes ALG one of the best-suited companies to augment clients’ manufacturing processes amid the COVID-19 pandemic.

Even now, ALG is using its labs to test product efficacy against human coronavirus strain 229E, as well as SARS-CoV-2, which causes COVID-19. By analyzing the reaction of the virus strain against various disinfectants, the company provides a basis for augmenting the portfolio of products that can be used in the fight against the coronavirus.

The Path of Protecting Lives

ALG’s battle against infection began long before the pandemic. As a company assembled from EPA-focused and FDA-regulated contract service laboratories, ALG has come a long way since its inception. For the past three decades, the company has centered its focus on delivering contamination control and disinfection testing expertise. ALG’s testing solutions are delivered through a portfolio of labs strategically located in regions dominated by pharmaceutical, medical device and antimicrobial manufacturers, facilitating central access for the developers and manufacturers of pharmaceutical and antimicrobial products. Moreover, with its best-in-class scientific and regulatory expertise, ALG provides impeccable testing services that are defined by unparalleled quality standards.

Compliance is the first step in improving the standards of pharmaceutical products, and so it is a huge responsibility for pharma organizations

“Our mission of ‘Helping Protect Life^®’ serves as our compass to help clients ensure that their products are safe and effective for patients,” Roth said. “We partner with our clients and guide them through every step of the process while maintaining open communication to ensure the best possible testing results.” And in this pursuit, the company establishes robust long-term relationships with its clients.

For example, ALG’s Minnesota lab focuses on assisting clients in the antimicrobial industry by providing Good Laboratory Practice (GLP) testing and support for EPA product efficacy claims. ALG has proven its capabilities in performing over 65 percent of the lab testing necessitated by the EPA for regulated infection control products. The Massachusetts and California labs collaborate with pharmaceutical developers, manufacturers 503As and 503Bs to offer cGMP product safety testing and environmental monitoring services.

Guiding Clients through the Compliance Maze

Highlighting one of the core drivers behind ALG, Megan Cosgrove, the company’s director of business development and marketing, said, “Compliance is the first step in improving the standards of pharmaceutical products, and so it is a huge responsibility for pharmaceutical organizations.” ALG helps relieve pharmaceutical companies of the burden of compliance management and works with them to ensure their adherence to the FDA requirements. And for this, ALG puts significant effort into raising the standards of pharmaceutical products through its expansive testing solutions in the pharmaceutical, medical device, biotech and healthcare spaces.

In addition, ALG provides comprehensive on-site environmental monitoring solutions and services geared toward drug manufacturers, compounding facilities, in-hospital pharmacies, long-term care facilities and home infusion pharmacies. “We help them manage and administer their USP <797> and cGMP compliance requirements efficiently and cost-effectively,” Cosgrove said.

All ALG colleagues are appropriately trained for carrying out a range of testing services, including environmental monitoring, air sampling, surface sampling and water sampling. Such robust capabilities allow ALG to strengthen its value to clients. Roth said, “We offer the same testing services and expertise as large contract service labs, and in doing so, we also maintain a high level of clarity and individualized customer service.”

With new sets of regulations making it to the healthcare sector, ALG is providing its clients with modules – complete with training videos – directing their teams toward effective environmental monitoring lab sampling. As part of this initiative, ALG offers a Compliance on Demand^™ kit for compounding facilities that need to adhere to USP <797> regulations. The Compliance on Demand^™ kit is the first step toward strengthening and expanding its sphere of influence in the pharmaceutical testing sector. Cosgrove said these kits facilitate a variety of tests that enable pharmaceutical technicians to pharmacists to enhance their regulatory compliance strategies. Clients can collect the lab samples themselves and send them to ALG, where they are verified following the highest quality standards. ALG also sends its teams to client facilities and certifies their technicians based on specific regulatory requirements.

Today, these robust functionalities are bolstering the foundation of ALG’s customers in the compliance landscape. A case in point is a pharma client who recently sought the help of ALG during the launch of their large cleanroom. The client had planned to take their product to market and required upfront performance qualification (PQ) testing before going to the FDA. With its large, experienced technician pool, ALG was able to complete testing thousands of samples in a matter of weeks. “It would have been a huge investment for the client to employ dedicated people and equipment for a PQ program,” Cosgrove said. With ALG’s knowledge and experience-driven team, the client was able to complete all the necessary compliance processes in the shortest time without having to invest heavily in extra personnel or equipment to facilitate the testing.

Work Culture Management is the Basis of Growth

Roth attributes ALG’s success to its unique work culture management. “It serves as a very important factor in our sustainable growth and our efforts to maintain solid relationships with customers,” he said. First on ALG’s list of differentiating factors is the use of effective communication channels among its employees, which allows them to clearly understand their roles and responsibilities in achieving the overall mission and customer commitments. ALG creates an environment that instills passion in its employees to work hard, be great team players, and foster creativity.

“Our mission of ‘Helping Protect Life^®’ serves as our compass to help clients ensure that their products are safe and effective for patients”

Keeping Pace with the Evolving World

Along with a motivated workforce, effective use of technology serves as a cornerstone for ALG’s growth. Over the past several years, the company has invested significantly in enhancing its information systems and bringing automation into its laboratory testing and documentation activities. These investments are driving ALG toward being an industry leader with respect to quick turnaround times, high-quality standards and communication portals for electronically sharing laboratory testing results.

“As consumers, we are keen to ensure that pharmaceutical products follow stringent quality standards,” Roth said. Therefore, ALG always exhibits zero tolerance for failure; every member of its team ensures not even the smallest of errors get by. Backed by dedicated quality assurance (QA) personnel, ALG has maintained an impeccable quality record, which has contributed to its solid reputation in the pharmaceutical space.

ALG was recently acquired by Element Materials Technology. Our two organizations share common values that focus on augmenting their services and continue being the most-trusted partners for their clients. The integration of our two companies will open doors to new opportunities, enabling ALG to build new relationships in the pharmaceutical and biotech sectors. Together with Element, ALG is planning to increase the distribution of its testing kits as the demand rises. “For us, the primary objective is always to remain proactive and responsive, thus effectively tackling new challenges as they arise,” Roth said.