Reliable Partnerships and Regulatory Assurance: The Backbone of Biopharma Logistics
In the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...
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No matter your modality or therapeutic use, Modality Solutions has the expertise to optimize the cold chain and guide your therapy through the regulatory framework from early development through approval. Our transport simulation testing technology and regulatory experience span the full range of therapeutic modalities and their diverse cold chain requirements.
Request a ConsultationMonoclonal Antibodies and Other Biologics
Monoclonal antibodies and other large-molecule biologics are sensitive to more than just temperature, making them difficult to transport.
As of 2019, some 350 biologics were commercially available, with biologics representing over 40% of the life science industry’s pipeline.
Biologics like monoclonal antibodies, vaccines, plasma-based therapies, and cell and gene therapies represent the industry’s fastest-growing segment. They’re also highly sensitive to five environmental hazards in transport and storage: temperature, vibration, shock, pressure, and humidity. Biologics can even interact with their primary packaging, creating more significant risks.
Regulators expect that you demonstrate your biologic can withstand environmental hazards and maintain efficacy, regardless of what happens at any point during distribution. But today’s complex pharmaceutical supply chains, often with multiple hand-offs, make it challenging to package, transport, and distribute biologics safely—especially during last-mile delivery. If these high-value drugs are adulterated in transit, the financial loss can be significant and the patient impact devastating.
Modality Solutions provides what biologics companies need to bring advanced therapies through approval and commercialization: validation master planning that demonstrates the robustness of your cold chain; transport simulation testing that delivers data capable of standing up to regulatory scrutiny; and thermal packaging validation to ensure the optimal packaging for your product.
CAR-T Cell Therapies and Other Regenerative Medicines
CAR-T cell therapies and other regenerative medicines are among the most promising modalities of the decade. They also involve the most complex supply chains to validate.
Over 360 cell and gene therapies were in early- or late-stage development as of 2020. Twenty cell and gene therapies received regulatory approval as of April 2021.
Personalized medicine approaches like CAR-T cell therapies use a unique, complicated, closed-loop supply chain that starts and ends with the patient—from collecting donor plasma through therapeutic delivery. Turnaround timelines are tight, and the chain of identity monitoring is strict. Whether autologous or allogenic, these high-value, groundbreaking therapeutics must be kept in a refrigerated, deep-frozen, or cryogenic state at different times in the cold chain, and they’re often transported in vials susceptible to breakage.
When it comes to transporting a therapy intended for a single patient, any delay or loss of supply chain control can prove life-threatening. The cold chain regulatory requirements for cell and gene therapies and other drugs with an elevated risk profile are rigorous and continually evolving—making the task even more challenging.
Modality Solutions provides the unrivaled combination of regulatory intelligence and advanced testing capabilities needed to optimize the cold chain for cell and gene therapies like CAR-T and other regenerative medicines with complex requirements. We have the experience and knowledge to guide these advanced therapeutics through their unique life cycles.
Let’s discuss the cold chain needs of your Cell & Gene Therapy Product
Antibody-Drug Conjugates (ADCs)
ADCs are transforming the treatment of cancer and other diseases. But these multi-component immunotherapies are complex to develop, manufacture, and distribute.
Approximately 45 ADCs were in a clinical trial phase, and two were approved as of December 2020. The ADC market is expected to grow to $7.5 billion by 2025.
By combining a cytotoxic anti-cancer drug, a highly specific monoclonal antibody, and a chemical linker, ADCs create a potent, targeted oncology treatment. Their use is rapidly expanding, especially in combination with immune checkpoint inhibitors. With nine FDA-approved ADCs and 45+ in clinical trials as of September 2020, these therapeutics have the potential to alter the cancer treatment landscape.
These multi-component immunotherapies involve complex stability considerations and a complicated manufacturing process, starting with the manufacture of the parent monoclonal antibody under current good manufacturing practices (CGMPs) to ensure robustness. Regulators require evidence that each component on its own and the final ADC can withstand the environmental hazards in transport, raising the cold chain challenges exponentially.
Modality Solutions understands the complexities that ADCs present across the entire development, manufacturing, and distribution process—and we provide the capabilities to reduce the risks and optimize the ADC cold chain.
Our proprietary Hazard and Operability Study (HAZOP) uniquely targets the risks of immunotherapies. Our Advantage Transport Simulation lab is the only independent lab that can concurrently test all five environmental hazards that occur in transit for each ADC precursor: monoclonal antibody, cytotoxic anti-cancer agent, and linker. And our Validation Master Plans ensure the robustness and viability of the ADC supply chain.
Pharmaceuticals
Small-molecule pharmaceuticals may be more robust than biologics. But for parenteral-administered drugs (those delivered non-orally, typically via injection) and other conventional therapies, the supply chain issues and regulatory expectations are no less demanding.
Of the 320 new drugs approved from 2008-2017, over three-quarters (219) were small molecule drugs.
Modality Solutions works with the world’s largest pharmaceutical manufacturers—advising them on reducing drug transport risks, augmenting their in-house capabilities, and lending our cold chain and regulatory experience to bring new therapies through approval fast. We provide the specialized regulatory and thermal packaging expertise to help pharmaceutical companies meet their supply chain needs without delays.
Drug-Device Combination Products
Innovative medical technologies have the potential to reshape healthcare. But they come with demanding regulatory requirements and unique supply chain considerations.
The market for drug-device combination products is forecast to grow at a compound annual growth rate of 3.9% through 2026, reaching a US market size of $100 billion.
Modality Solutions provides the technical capabilities and regulatory expertise to help medical device innovators meet rigorous FDA requirements for combination products. We conduct transport simulation studies, run engineering-based analyses of existing studies to design a data bridging strategy, and provide the regulatory know-how support needed for a successful submission.
Let’s discuss the cold chain needs of your Combination product
The storage and shipping requirements of mRNA therapies tend to require the use of expensive and complex deep-frozen cold chains.
The storage and shipping requirements of mRNA therapies tend to require the use of expensive and complex deep-frozen cold chains.
Storing therapies at 80°C can use up to four times more energy than keeping them at 5°C and can be three times more expensive than a storage unit that operates at refrigerated temperatures. Shipping deep-frozen therapies require dry ice, which adds weight to the package and increases shipping costs.
Modality Solutions has the unique and specific experience to help Pharmaceutical Companies looking to bring mRNA Vaccines through approval and commercialization. With extensive expertise in validation master planning that demonstrates the robustness of your mRNA cold chain, advanced transport simulation testing that delivers data to stand up to regulatory scrutiny, and thermal packaging validation to ensure the optimal packaging for your vaccine.
In the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...
read DetailsBiologic
In the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...
read DetailsBiologic
Are you aware of the open data files published online by the FDA? This...
read DetailsBiologic