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CDMO
At LTS, we have a somewhat unique model where we support partners who are adopting an LTS platform as well as those who have developed their own technology and need a high-quality manufacturing partner that can deliver global volumes.
Supporting innovation from concept to market
Bringing a pharmaceutical product to market requires far more than a promising molecule. It demands careful development, robust process design and a manufacturing strategy that can support the entire development process from feasibility, first prototypes, clinical trials through to commercial launch and lifecycle management. A CDMO provides the capabilities needed to move efficiently through these stages while helping partners maintain focus on their core scientific objectives.
A CDMO typically offers integrated services across the full product lifecycle. These may include formulation development, analytical testing, process optimisation, scale-up, clinical manufacturing, validation, and commercial production.
By bringing these functions together within one consistent and valued partnership, pharma companies create a more seamless path from early development to market supply. This integrated approach can help reduce complexity, improve coordination, and support greater continuity across each phase of development.
Working with a CDMO offers important strategic advantages. It reduces the need for major investment in facilities, equipment, and specialised skils, while providing access to proven technical knowledge and manufacturing experience. In the case of LTS, this expertise and know how extends across a wide range of delivery technologies including Transdermal Therapeutic Systems, Oral Thin Films, Microneedle Array Patches, Topical Patch Systems, On Body Delivery Systems and Nasal Drug Delivery. To find out more about our technology platforms click here.
For our partners, this model offers flexibility and speed, allowing its teams to adapt to changing development needs, respond to regulatory expectations and scale production with confidence.
Expertise matters
In pharmaceutical development, expertise is essential. Each product presents unique scientific, technical, and regulatory challenges, and success depends on the ability to manage them with precision. A strong CDMO partner does more than provide capacity. It contributes insight, continuity and execution across the entire journey, helping ensure that development and manufacturing are aligned with long-term product goals.
A partner for progress
As the pharmaceutical industry continues to evolve, the role of the CDMO becomes increasingly important. Pharma companies are seeking trusted partners who can combine innovation with operational excellence and support the delivery of high-quality products to patients around the world.
For more information on our CDMO capabilities click here
Pharmaceutical development, from first principles, feasibility, prototyping and clinical trials through to manufacturing of high volumes is defined by complexity, precision and high standards. As programmes move from concept to commercialisation, many companies choose to partner with a contract manufacturer that is equipped with specialised expertise, dedicated infrastructure and reliability through experience.
Necessarily contract manufacturing in pharma is more than an outsourcing arrangement. It is a strategic collaboration that helps bring products to market efficiently, consistently and in compliance with ever evolving, ever increasingly demanding regulatory expectations. For organisations seeking to scale with confidence, the right partner can make a seismic impact at every stage of the journey.
At its best, contract manufacturing represents a seamless extension of your own organisation. It allows pharmaceutical companies to focus on innovation, development and market strategy while relying on an experienced partner to manage your manufacturing requirements.
This model is particularly valuable in an industry where quality and continuity of supply are essential to ensure patients continue to benefit from often lifesaving or life enhancing therapies. Only by working with a trusted manufacturing partner, can companies reduce the burden of capital investment while responding with agility to shifting market needs.
The pharmaceutical sector operates under strict regulatory scrutiny and exceptionally low tolerance for error. Every process must be built to protect product quality, ensure traceability, and support the highest levels of patient safety.
Contract manufacturing helps companies meet these demands while maintaining operational agility. It can shorten time to market, improve production efficiency, and provide access to specialised equipment or expertise that may not be available internally. For many organisations, it also offers a more flexible path to growth without compromising standards.
The value of contract manufacturing extends well beyond production itself. A strong partner contributes insight during planning, alignment during development and consistency during scale-up and supply.
That value can only be created through early collaboration. When manufacturing considerations are addressed from the outset, it becomes easier to manage specifications, reduce risk and establish a more reliable path forward. Clear communication around timelines, sourcing, and quality expectations also helps prevent delays and supports long-term operational stability.
Not all manufacturing partnerships are created equal. In pharma, the best outcomes depend on technical capability, regulatory discipline and a shared commitment to quality.
A strong contract manufacturing partner should offer more than capacity. It should bring proven experience, robust systems and the ability to work as an extension of your team. Just as importantly, it should support transparent planning and responsive execution, ensuring that every step is aligned with your programme goals.
When managed with the right partner, it becomes a foundation for sustainable growth. The result is not simply outsourced production, but a relationship built to support quality, continuity and long-term success.
TTS
Most modern patches consist of (at least) three essential layers:
- Backing Layer: The outermost waterproof film that protects the medication from environmental factors like water or friction.
- Drug Containing, adhesive layer: The core where the medication is stored, dissolved or dispersed within a solid polymer adhesive layer.
- Release Liner: A protective film that is peeled off just before applying the patch to expose the adhesive.
Most modern patches consist of (at least) three essential layers:
- • Backing Layer: The outermost waterproof film that protects the medication from environmental factors like water or friction.
- • Drug Containing, adhesive layer: The core where the medication is stored, dissolved or dispersed within a solid polymer adhesive layer
- • Release Liner: A protective film that is peeled off just before applying the patch to expose the adhesive.
Once applied, the drug moves from the patch into the stratum corneum (the skin’s outermost barrier layer). It then diffuses through the deeper epidermis and dermis until it reaches capillaries, which absorb the drug into the general circulation.
- Avoids ‘First-Pass’ Metabolism: By bypassing the digestive system and therefore the initial metabolization by the liver, the drug remains more potent and causes fewer gastrointestinal side effects.
- Consistent Blood Levels: TTS provides a steady, controlled release, preventing the sudden peaks and troughs in medication levels often seen with tablets.
- Improved Compliance: Patches are non-invasive, easy to apply, and can last from several hours to 7 days, making them ideal for patients who forget daily pills or have difficulty swallowing.
- Instant Termination: If an adverse reaction is experienced, the drug delivery can be stopped simply by removing the patch.
Patches are widely used for various conditions, such as Smoking Cessation, Pain Management, Hormone Therapy and Chronic Conditions such as Alzheimer’s or Parkinson’s disease, angina pectoris and hypertension.
To find out more about our technology click here
MAP
Microneedle Array Patches (MAPs), or microneedle patches, are a next generation drug delivery system designed to be a painless, non-invasive alternative to traditional injections. Applied like a small adhesive bandage, these patches use an array of hundreds to thousands of microscopic needles to deliver medication directly through the skin.
A MAP is a hybrid device that combines the direct delivery of an injection with the ease of a transdermal patch. Its primary components include:
- Microneedle Array: A grid of tiny projections, typically 300 to 1,000 μm in length on a baseplate.
- Active Pharmaceutical Ingredient (API): The medication or vaccine, which is either coated onto the needles, is encapsulated within them or stored in a reservoir.
- Backing Layer: A flexible material that protects the microneedle array and ensures it stays in place.
- Adhesive Film: Ensures secure patch adhesion to the skin’s surface.
MAPs bypass the stratum corneum, the skin’s tough outer barrier, to deliver drugs into the immunologically rich epidermis and dermis. The process varies by patch type:
- Dissolving Needles: The microneedles are made of water-soluble polymers (like PVA or PVP) that dissolve upon contact with skin moisture, releasing the medication directly into the tissue.
- Coated Needles: Solid needles coated with a dry drug formulation are pressed into the skin; the coating dissolves rapidly, leaving the needles to be removed with the patch.
- Hollow Needles: Tiny bores within the needles allow liquid medication to flow from a reservoir into the skin.
- Hydrogel Needles: These needles swell by absorbing interstitial fluid, creating a jelly-like conduit through which drugs can diffuse over time.
- Painless Administration: The needles are short enough to avoid hitting deep-seated nerve endings.
- Thermostability: Medications are often in a dry state, which can eliminate the need for an expensive cold chain.
- Self-Administration: Because they are easy to use, patients can often apply them at home, reducing the need for trained medical staff.
- Safety: MAPs eliminate the risk of needlestick injuries and do not generate sharps waste.
- Enhanced Immune Response: By targeting the skin layers with high density of immune cells, MAPs can be more effective than traditional vaccine injections.
Microneedle Array Patches for pharmaceutical applications are not on the market, yet. Clinical studies are conducted with MAPs containing, e.g. vaccines for influenza, measles-rubella, COVID-19, and Hepatitis B; Chronic disease management for the long-acting delivery of contraception or of insulin for diabetes treatment; cancer treatment i.e. local application of drugs for skin cancer
To find out more about our technology click here
OTF
Oral thin films (OTFs), also known as oral soluble films, are small polymeric sheets designed to dissolve rapidly when placed in the mouth, either on the top of the tongue, under it (sublingual), or against the inner cheek (buccal). They provide a discreet and convenient way to deliver medication, especially for those who have difficulty swallowing pills. There are two common types of OTF:
- Orodispersible films which dissolve instantly in saliva and are swallowed
- Oromucosal films which adhere to the mouth’s lining to release medication directly into the bloodstream.
A typical oral thin film consists of:
- Active Pharmaceutical Ingredient (API): The actual medication (usually 5% to 30% of the film’s weight).
- Film-Forming Polymers: The backbone of the film, such as HPMC, pullulan, or starch.
- Plasticizers: Additives like glycerine or PEG 400 that provide flexibility and prevent brittleness.
- Taste-Masking Agents: Sweeteners and flavours to hide the bitter taste of drugs.
- Saliva Stimulants: Ingredients like citric acid that encourage mouth-watering to speed up dissolution.
Medication from OTFs enters the system through two primary pathways:
- Direct Absorption (Transmucosal): For films placed under the tongue or against the cheek, the drug passes directly through the highly vascularised oral mucosa into the bloodstream. This avoids the ‘first-pass effect’ where the liver breaks down medication before it reaches the rest of the body.
- Gastrointestinal Absorption: For standard fast-dissolving films, the strip dissolves in saliva and the resulting liquid is swallowed, where it is then absorbed in the stomach or small intestine.
- Ease of Use: No water is required for administration, making them ideal for travel or emergency situations.
- Improved Compliance: Easier for children, the elderly, and patients with swallowing difficulties or a fear of choking.
- Faster Action: Direct absorption into the bloodstream can lead to a quicker therapeutic effect compared to swallowed tablets.
- High Precision: Each strip provides a pre-measured, accurate dose.
To find out more about our technology click here
NDD
Liquid nasal drug delivery (NDD) is a non-invasive method of administering medication directly into the nasal cavity, primarily as sprays or drops. This route is highly versatile, used for both local treatment of nasal conditions (like allergies) and systemic delivery where the drug enters the bloodstream to treat conditions elsewhere in the body.
A liquid nasal spray delivery system typically consists of two primary elements:
- The Formulation: This is the liquid containing the drug. The drug can be dissolved in the liquid, mixed in as tiny solid particles, or contained in an emulsion, where two liquids are blended together. It often includes excipients like buffers to maintain pH, viscosity modifiers, and preservatives.
- The Device: a metered dose spray: Single, double or multiple dispense providing a precise, consistent volume of medication in a fine mist.
Medication is absorbed through the nasal mucosa, a thin, highly vascularised tissue. It enters the body through three main pathways:
- Local Action: The medication acts locally, primarily in the superficial regions of the nasal mucosa to treat local inflammation or congestion.
- Systemic Absorption: The drug passes through the mucosal epithelial cells (transcellular) or between them (paracellular) directly into the dense network of blood vessels, entering the general circulation.
- Nose-to-Brain: Certain drugs can bypass the blood-brain barrier by travelling along the olfactory or trigeminal nerves, providing a direct route to the central nervous system.
- Rapid Onset: Because the nasal cavity is rich in blood vessels, absorption is fast, often providing a quick therapeutic effect.
- Bypasses First-Pass Metabolism: Unlike oral drugs, nasal medications do not pass through the digestive system or liver first, which prevents them from being broken down before reaching the bloodstream.
- Non-Invasive: It provides a needle-free alternative for drugs that would otherwise require injection, improving patient comfort and compliance.
- Ease of Use: Most devices are portable and designed for easy self-administration.
To find out more about our technology click here
Nasal Sprays
Sometimes referred to as a uni-spray or uni-dose device, unit-dose nasal spray devices deliver a single 100µL spray of drug product. The device does not require priming and is disposed of after one use. These devices are ideal for delivery of drugs for indications that require quick relieve, and are therefore ideal for administration of drugs for emergency use indications
At LTS, we fill more unit-dose nasal spray devices than any other contract manufacturer (CMO). We have multiple filling and assembly lines available, enabling us to support unit-dose projects from development and clinical scale to commercial production.
The bi-dose nasal spray device is designed to accurately deliver two metered nasal spray doses. The device does not require priming and is disposed of after use. Depending on the application, the device can be used to administer medication in two ways…
- a single dose/spray is administered and, depending on the reaction of the patient, a second dose is available if the medical episode is not controlled;
- 100 µL of spray is dosed into each of the patient’s nostrils (two sprays total) for one full dosage. This second application supports nasal delivery for drug substances which require higher doses (e.g. because of low solubility) that cannot be delivered in a unit-dose spray.
At LTS, we have more experience with filling and assembly of the Aptar bi-dose device than any other manufacturer. We have multiple filling and assembly lines available, enabling us to support bi-dose projects from development and clinical scale to commercial production.
Drug products delivered as nasal sprays frequently include preservatives within the formulation to prevent contamination and microbial growth during the product’s shelf life. Preservative-free nasal sprays avoid using these chemical additives. They are manufactured aseptically to maintain sterility. To achieve this, bulk drug product is filtered through a 0.22µm filter prior to being filled into a nasal spray vial under aseptic processing conditions. After filling, still within sterile settings, a nasal spray pump is applied. These pumps are specially designed to include a filter that prevents microbial contamination of the formulation from outside air after actuation.
LTS is one of only a few contract manufacturers (CMO) worldwide with the capability of manufacturing preservative-free nasal spray products. We can fill these products at both clinical and commercial scales.
Are nasal sprays drug-device combination products?
Nasal sprays are drug-device combination products as per FDA 21 CFR 3.2(e) of the United States Code of Federal Regulations. This states that the term ‘combination product’ applies to: “A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity”.
Going further, the U.S. Food & Drug Administration (FDA) identifies and describes nine different types of combination product, with nasal sprays falling under Type 2: “Prefilled Drug Delivery Device/ System”, where “drug is filled into or otherwise combined with the device AND the sole purpose of the device is to deliver drug”.
Since nasal sprays are considered drug/device combination products, the formulation, development and device selection are critical to the effective performance of the product. At LTS, we have a full research and development team with years of experience in nasal spray formulation development and device selection.
To learn more about our nasal spray research and development capabilities click here
OBDS
OBDS, also known as wearable injectors or on-body injectors, are portable medical devices that adhere to a patient’s skin to deliver medication over a controlled period. They are primarily used for subcutaneous (SC) administration of large-volume or high-viscosity drugs that cannot be delivered through standard autoinjectors.
An OBDS typically consists of several integrated subassemblies designed for precision and patient comfort:
- Drug Reservoir/Cartridge/Vial: A container (often made of specialised polymers or glass) that holds the medication.
- Adhesive Patch: A medical-grade adhesive that secures the device to the skin, often on the abdomen, thigh or upper arm
- Insertion Mechanism: A system that deploys a small, typically hidden needle into the subcutaneous tissue optionally using a soft cannula.
- Drive System: A mechanical or electronic motor that pushes the medication from the reservoir into the body.
- Controller/Electronics: Some systems include programmable electronics for precise dosing and Bluetooth connectivity for remote monitoring.
- Device housing (outer shell): Rigid enclosure that integrates all mechanical, electronic and drug-containing components
The medication is delivered through the following process:
- Activation: Once attached to the skin, the user typically presses a button to activate the device.
- Insertion: A needle or cannula is automatically inserted into the subcutaneous adipose tissue just beneath the skin.
- Controlled Infusion: The drive mechanism delivers the drug at a precisely controlled rate over minutes, hours or even days, rather than as a single rapid bolus.
- Absorption: The drug moves from the subcutaneous tissue into the small blood or lymphatic capillaries to reach systemic circulation.
OBDS technology offers several benefits over traditional needles or autoinjectors:
- Higher Dosing Capacity: They can deliver volumes exceeding 3mL, up to 50 mL, which is beyond the limit of standard autoinjectors.
- Improved Comfort: Slower delivery reduces tissue stress and back-pressure, which significantly decreases injection pain, especially for high-viscosity solutions
- Healthcare Cost Savings: Enables convenient home based administration, reducing clinic visits and associated medical costs.
- Safety: Hidden needle mechanisms reduce needle phobia and mitigate the risk of accidental needlestick injuries.
To find out more about our technology click here