EAWL Storage Facility

Gaining GMP Storage Space Utilizing a 3rd Party Solution in Massachusetts

Intro

Are you a life sciences manufacturer struggling to find enough storage space for supplies and materials? Outsourcing to a 3rd party GMP storage facility is your best solution.

Storage providers in Massachusetts have state-of-the-art facilities and strict adherence to Good Manufacturing Practices (GMP), so that you can trust that your materials will be safe, organized, and easily accessible when you need them.

This article explains how utilizing a 3rd party satellite facility can help maximize your storage space and streamline your materials management process.

Exploring the Benefits of a 3rd Party Satellite Facility for Enhanced Materials Management

Firstly, a validated storage facility is essential for life science manufacturing. Many materials used in this industry require specific temperature and humidity levels to maintain their efficacy and integrity. With a 3rd party provider like Euro American, you can ensure that your materials are stored in validated conditions, minimizing the risk of degradation, and maintaining the quality of your products.

Additionally, managing single-use disposables can be a challenge due to their bulky nature. By utilizing a third-party satellite facility, you can free up valuable space in your own facility and store these disposables in an organized and efficient manner until you need them. This streamlines your production process and eliminates the hassle of finding space for these essential items.

Lastly, cold-chain transportation is often required for temperature-sensitive materials. It is essential to assess the provider’s capabilities in managing cold-chain transportation. A 3rd party storage facility equipped with proper cold-chain management systems, including temperature-controlled vehicles for transporting the goods between your facility and theirs, will maintain the integrity of your materials and ensure on-time availability. This alleviates any logistical challenges of maintaining temperature control and provides peace of mind for quality.

Selecting the Right 3rd Party Provider: Key Considerations

When selecting a 3rd party provider for stockpiling supplies and materials, make sure the provider has the following two things in addition to the normal cGMP requirements: Experience and Guaranteed Same-Day Access.

Experience: First and foremost, it is crucial to ensure that the provider has experience and expertise in handling the specific needs of life science manufacturing. Choose a provider like Euro American that has been specializing in this industry for nearly six decades and understands the unique challenges and requirements involved.

Guaranteed Same-Day Access: The goal when outsourcing is to gain storage space without sacrificing quality or accessibility. Make sure the provider guarantees same-day access to your materials being stored. The provider should be equipped with temperature-controlled vehicles, maintain 24/7 availability, and guarantee same-day delivery from their facility to yours.

Final Thoughts

As a life science manufacturer, you know the struggles of finding adequate storage space for your supplies and materials. Utilizing a third party GMP Storage Solution in Massachusetts provides you with the space you need and ensures that your items are safe, organized, and easily accessible when you need them.

Negative Effects of the Inflation Reduction Act on the Life Sciences Manufacturing Industry

US Launches Attack on Drug Developers

The Life Science Manufacturing industry has long been hailed as the bedrock of groundbreaking medical research and innovation, particularly in the realm of drug development. With the United States leading the charge, accounting for 55% of approved drugs globally, the mutualistic relationship between public and private sectors has undeniably set a global standard. However, the recently introduced Inflation Reduction Act (IRA) threatens to destabilize this fine balance, sending shockwaves through the industry.

Public-Private Symbiosis Underpins Drug Development Success

The National Institutes of Health (NIH) plays a pivotal role in facilitating biotech advancements. Dr. Hans Sauer of the Biotechnology Innovation Organization (BIO) emphasizes that the existing alliance between NIH and private biotech firms is the cornerstone of American leadership in drug development. In 2020, U.S. investment in biomedical R&D stood at a staggering $245 billion, with the federal government contributing $61.5 billion (25%). Meanwhile, the private sector bore the lion’s share with $161.8 billion (66%).

While a significant portion of NIH funding aids drug development, most of its resources are channeled into basic research. This foundational research subsequently propels private entities to invest in the next stages of drug development, fostering an environment of innovation and risk-taking.

The Price Debate: More Than Meets the Eye

Recent discussions around NIH-supported drug development have steered towards potential price controls. Detractors argue that NIH backing should correlate with reduced drug prices. However, Dr. Sauer refutes this notion, pointing out that private sector contributions significantly outweigh public investments. Moreover, the private sector predominantly shoulders the risk of potential drug failures, emphasizing the peril in introducing arbitrary price caps.

Echoing these concerns, Rachel King, CEO of BIO, warns that the IRA’s price controls are detrimental to the biotech industry’s intricate innovation ecosystem. The disincentives introduced by the IRA, particularly regarding orphan drugs that treat rare diseases, could stymie critical research endeavors. By limiting orphan drugs to a single indication for pricing exemptions, the Act inadvertently hampers the exploration of these drugs’ wider potential applications.

Bridging the Policy Gap: The Way Forward

The backlash against the IRA isn’t just limited to industry stakeholders. Legislative voices have also begun acknowledging the Act’s potential pitfalls. As King articulates, there’s a pressing need for bipartisan efforts to rectify problematic facets of the IRA, ensuring that it doesn’t stifle innovation.

Highlighting the crux of the issue, Christina Hochul of Alexion Pharmaceuticals underscores the unintended challenges presented by the IRA’s orphan drug exclusion. Following the Act’s implementation, various entities, from patient advocates to biotech investors, have spotlighted this legislative blind spot, advocating for prompt amendments.

Amy Rick, Chair of the IRA Orphan Task Force, elucidates the long-term ramifications of the current legislation. Decisions influenced by the IRA today could adversely affect the industry for the next decade. With some companies already halting orphan drug research and venture capitalists growing hesitant, the repercussions are palpable.

As discussions intensify, the Centers for Medicare and Medicaid Services (CMS) emerges as a key player. Over the past year, organizations have actively engaged with CMS, emphasizing the need to reevaluate the IRA’s ramifications, especially concerning orphan drug exclusions.

Conclusion

While the Inflation Reduction Act was designed with commendable intentions, its inadvertent consequences on the life science manufacturing sector cannot be ignored. Collaboration between industry stakeholders, patient advocates, and policymakers is paramount. As the industry continues to navigate these challenging waters, it’s essential to strike a balance that upholds both patient welfare and innovation. Only with mutual understanding and comprehensive legislative revisions can the life science manufacturing industry continue its legacy of pioneering drug development.

Sources:

Inflation Reduction Act: Unintended consequences for rare disease, orphan drugs
BIO Vice Chair John Crowley to Congress: IRA reduces access to innovative drugs
Why drug price controls ‘risk the future of investment’ in R&D
BIO’s Rachel King weighs in on IRA and the biotech industry in new podcasts
BIO expert lauds beautiful relationship between NIH and biotech