Molecular MS Diagnostics
Expediting Drug Commercialization with Superior Analytical Services

Drug development is fundamental to bringing a life-saving compound to the market. However, commercializing a drug has always been an arduous process, with research and development being the most critical and time-sapping phase. Research laboratories reach out to CROs that can help them complete the R&D stage in a timely manner; that’s when a number of constraints come into play.

Partnering with a typical CRO is costly, while they deal with endless middlemen, time-consuming regulatory approvals, and endless paperwork. This also, in turn, leads to considerable delay in bringing the drug to market. This is where Molecular MS Diagnostics (MMSD) makes a major difference, helping research laboratories speed up their drug development processes with its exclusive R&D and GMP analytical services.

MMSD is on a mission to augment research laboratory equipment, space, time, and in-house research expertise to optimize drug development processes while at the same time, saving their clients from middlemen, third parties, and endless approvals to give them the fastest, and most successful outcomes.

“We provide uniquely powerful analytical, bioanalytical and strategic product development services to our clients to accelerate their research needs and empower them to improve more and more patient lives,” says Dr. Daniel Magiera, Owner of MMSD.

With a sprawling 10,000 square feet of lab space and cutting-edge equipment, the company provides numerous analytical services, including assay and impurity HPLC testing for drug products, extractables and leachables testing, and counterfeit drug testing. Under their purview of bioanalytical services, MMSD provides plasma/ blood stability assays, urine analysis of generic drugs/NCEs, and UPLC-MS/ MS method development services. The company also offers stability testing, pre formulation development, photostability testing, feasibility studies, and various other product development services to help laboratories shorten the time to drug commercialization.

MMSD’s line of impeccable services are attributable, in part, to Dr. Magiera’s expansive experience in this domain. He started as a senior analytical chemist providing various analytical solutions to both researchers and formulation chemists for synthesizing and tableting drugs. Dr. Magiera supported all analytical/bioanalytical aspects of a drug development company and built three analytical/bioanalytical labs during the company’s expansion. Notably, he developed an extensive scope of bioanalytical skillsets by fostering development processes for drugs scheduled for a controlled, targeted release. This was when Dr. Magiera came across a market challenge. Noticing that the traditional analytical techniques used in R&D services hadn’t quite evolved on par with the latest industry standards, he eventually laid the cornerstone of MMSD—a company aimed at using the latest analytical solutions to handle all R&D and GMP analytical product testing needs for life science organizations and laboratories.

The MMSD Edge

The key differentiating factor, what the company calls the MMSD edge is their ACE (Achieve, Communicate, Execute) methodology.

The methodology entails following all the steps used by MMSD to oversee a drug development project for its clients.

It starts with MMSD’s detailed inspection of project specifications and voluminous amounts of medical literature to be able to expertly interact with clients and find their core objectives. In the final phase, after MMSD takes into account all of the client’s specified requirements, they select the equipment and staff needed to efficiently execute a particular project. The entire methodology is repeated to come up with different solutions to any issue surrounding a client’s drug development processes and drug testing schedule.

Along with the personalized approach to every project, MMSD also focuses on developing a robust quality management system (QMS). The QMS ties all of the company’s analytical processes to their SOPs, assuring clients about the quality of testing results. By emphasizing data integrity, MMSD also ensures their QMS reports solid, actionable data on client clinical trials that can be used to answer drug approval questions by regulatory agencies.

With regulatory agencies now asking for more detailed analytical information on clinical trial processes, there needs to be highly advanced, analytical equipment-based assays to help answer those questions. To that end, MMSD deploys the highest grade of specialty equipment to quickly identify drug formulation issues and troubleshoot various assays to avoid being subjected to rigorous regulatory questions.

The Hallmark of Excellence

Among a slew of success stories that prove how MMSD has helped pharma and medical companies surpass regulatory hurdles and bring products to market is one of a company facing stringent regulatory questions regarding the characterization of their polymers on a pre-approved product. Said company neither had the in-house expertise nor the necessary equipment to properly characterize the molecular weights of the polymers they were developing. MMSD stepped in and deployed their analytical expertise and specialized equipment to create a defined protocol, executed it, and created quality-reviewed the needed supplementary technical data reports. After reviewing the report, the client was able to answer every critical FDA question and launch the product, within three weeks.

On another occasion, a client’s product was on a clinical hold. It was a critical situation because the client needed to complete the clinical study in order to obtain the data necessary to present to a board of investors and move into their capital raising rounds. As soon as MMSD took the steering wheel, they were able to adopt an HLPC assay that required them to perform derivatization and validated this critical method. Within four weeks, the product was off clinical hold and the client was able to successfully complete their study. As a small sized company free of middle management, MMSD was able to turn the attention of its entire workforce toward this particular project to stay ahead of all deadlines.

Moving ahead, MMSD is open to collaborating with other companies to provide a variety of analytical and product development services to help more life science companies achieve their research goals. In view of this objective, MMSD has partnered with MedCommence, a company that provides R&D, clinical, and regulatory expertise to help life science organizations launch their polymer innovations. Last but not least, MMSD is also making sure that the more the pharma industry shifts from tablets to device-oriented medications driven by groundbreaking technologies, the more they are going to play a crucial role in that evolution. Until then, MMSD will continue accelerating drug development programs for various pharma and biotech organizations with the perfect amalgamation of continuous innovation, agility, and collaboration.