Therapies We Work With

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.

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Monoclonal Antibodies and Other Biologics

Cold Chain Expertise for Monoclonal 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.

The Challenge

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.

How Modality Solutions Can Help

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.

Why Do Biologics Companies Choose Modality Solutions?

Let’s discuss the cold chain needs of your Biologic product

  • We’ve worked with over 100 biologic therapies, 90% of which were monoclonal antibodies.
  • We’ve had 150+ successful interactions with regulators on behalf of biologic companies.
  • Dozens of regulatory agencies have accepted the data generated from our proprietary transport simulation technology since 2014
  • Our biologics experience spans the spectrum—including monoclonal antibodies like MorphoSys’ MONJUVI™, parenteral drugs in pre-filled syringes from companies like Teva and Regeneron, biosimilars like filgrastim injection products from APOTEX; orphan drugs; and vaccines for COVID-19 and Ebola.
  • We’re highly experienced with drugs on accelerated approval paths, including Fast Track, Breakthrough, and Priority Review designations
  • We know how to manage rolling regulatory submissions and provide timely feedback on agency requests.
  • We’ve designed and executed comprehensive cold chain validation in as little as three months for fast-track biologics.

CAR-T Cell Therapies and Other Regenerative Medicines

Optimizing the Cold Chain for CAR-T Cell and Other Regenerative Therapies

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.

The Challenge

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.

How Modality Solutions Can Help

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.

Why Do the Makers of CAR-T Cell and Other Regenerative Therapies Choose Modality Solutions?

Let’s discuss the cold chain needs of your Cell & Gene Therapy Product

  • We’ve worked with over half the CAR-T cell therapies submitted for FDA review.
  • We’re highly experienced with plasma-based products
  • We’ve designed and qualified dozens of thermal packaging solutions for CAR-T therapy supply chains, including cryogenic temperature packaging.
  • We understand the nuances of global regulatory expectations for cell and gene therapies—and we know how to achieve a successful filing with our data presentation techniques.
  • We keep current on GMP and GDP best-demonstrated practices, especially as more CAR-T and other cell and gene therapies move through submission and review.

Antibody-Drug Conjugates (ADCs)

Optimizing the Cold Chain for 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.

The Challenge

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.

How Modality Solutions Can Help

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.

Why Do ADC Developers Choose Modality Solutions?

Let’s discuss the cold chain needs of your ADC

  • We’ve worked with most of the FDA-submitted ADCs to date.
  • Our ADC experience includes a wide range of applications, including a metastatic triple-negative breast cancer ADC therapy and a Fast-Track Breakthrough orphan drug for ovarian cancer.
  • Our unique transport simulation technology uses proven best practices specific to monoclonal antibodies and parenteral pharmaceuticals.
  • Our proprietary HAZOP identifies the risks unique to immunotherapies and designs effective mitigations.
  • Our validation master planning services help protect fragile, temperature-sensitive ADC components that are especially tough to transport and store.

Pharmaceuticals

Optimizing the Cold Chain for Small‑Molecule 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.

The Challenge

Drugs delivered parenterally are more sensitive to environmental hazards than those in capsule or tablet form. Plungers can move in transit and vials can break, creating sterility risks. Controlled room temperature pharmaceuticals can be more difficult to manage than therapies with stricter cold chain requirements, and regulators are starting to require more stringent temperature control measures. And pharma companies are racing against the clock to speed time-to-market and stay ahead of the competition.

How Modality Solutions Can Help

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.

Why Do Pharmaceutical Companies Choose Modality Solutions?

Learn about how we work with Pharmaceutical companies

  • We understand the complex interrelationship between a parental drug formulation and the environmental hazards it can encounter in transit.
  • We’ve applied our supply chain and regulatory expertise to a wide range of small-molecule drugs, like fragile sublingual tablets manufactured by Alcami, an anti-cancer nanotherapeutic from Merrimack Pharmaceuticals, and a unique anti-cancer quinolone from Sunesis.
  • We’ve conducted plunger movement studies to help pharmaceutical companies reduce risk when transporting pre-filled syringes and other parenteral drugs.
  • Our advanced test design and planning can supplement a pharmaceutical company’s in-house resources and capabilities.
  • We operate the only independent, state-of-the-art transport simulation lab, capable of concurrently testing all five major environmental hazards that can occur in transit.
  • We offer guidance on how to optimize existing drug packaging and shipping lanes.

Drug-Device Combination Products

Optimizing the Cold Chain for 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.

The Challenge

For medical technologies like drug-device combination products, the regulatory approval process can be multifaceted. A new NDA or BLA filing for a combination product needs to bridge any existing data for the individual components—demonstrating that the combination product meets biologic and device regulatory requirements. Yet, the devices and drugs used in these new medical technologies are often susceptible to temperature, shock, and other hazards in transit, posing risks to device functionality and drug efficacy, purity, and potency.

How Modality Solutions Can Help

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.

Why Do Drug‑Device Innovators Choose Modality Solutions?

Let’s discuss the cold chain needs of your Combination product

  • We’ve worked with 20+ combination therapies, helping obtain approval or improve the cold chain post-approval.
  • Our drug-device therapy experience spans the spectrum—from pre-filled syringes for a unique dental anesthetic, to a drug-eluting vascular scaffold, to a unique system for treating abdominal aortic aneurysms.
  • We’ve worked extensively with CDER and CBER—the two centers involved in combination drug-device approvals—and we know how to navigate a successful approval with both.
  • We have the specialized technical capabilities to assess medical device functionality and plunger movement / pre-filled syringes
  • Our transport simulation studies provide the bridging data regulators demand—testing transportation risks along the edges of the network design.
  • Our team includes both biomedical and device engineering specialists.

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