Pharmaceutical Product Development
We believe that pharmaceutical products should be designed with the goal in mind, in order to deliver safe, effective, high-quality, and easy-to-use medicines for patients.
At ten23 health we integrate different processes such as formulation development, manufacturing process design, primary packaging, and device selection. Furthermore, we carefully develop analytical methods for an appropriate control strategy to achieve a global product design from the start.
Development Strategy
We anticipate issues, solve problems, and deliver solutions, resulting in a highly stable, effective, and competitive pharmaceutical product.
Our experts advise on effective mitigation strategies during development to de-risk the challenges that may occur during the R&D process, such as unexpected instabilities, product defects, or usability issues.
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ten23 health supports pharma & biotech clients in designing their Target Product Profile (TPP) and the best Chemistry, Manufacturing and Controls (CMC) roadmap from preclinical to clinical to commercial.
For early-stage development, we support our clients in selecting the right molecules and/or therapeutic modalities, and ensure the appropriate set-up for later development from a pharmaceutical and stability perspective.
For commercial-stage medicines or post-launch formulation line extensions (product optimization), we develop competitive and stable formulations, primary packaging and devices, and manufacturing processes, and ensure quality-by-design.
ten23 health supports our clients toxicological and clinical studies, enabling speed, material quality and managing and mitigating development risks. We provide stage-appropriate formulations, analytical methods, primary packaging, and manufacturing processes: we deliver materials for stability testing for regulatory filings, and for use in preclinical studies.
Our work is based on a sound knowledge of the pharmaceutical industry, and a broad scientific expertise, as well as extensive regulatory experience. We perform all necessary experiments, ensuring regulatory compliance and patient safety at all stages.
Formulation Development
Selecting appropriate formulations for a given active molecule (or modality) is crucial, as the formulation determines not only the product’s stability, but also its storage and shipment, as well as its usability.
At ten23 health, our specialists can design lean strategies, for example for moving molecules quickly into Tox, Phase 1, and PoC studies (early stage), or execute full development scopes, including QbD- and design space-based filings, for ensuring robust products for commercial launches (late stage or post-launch). We will be happy to advise you and align your strategy to the level of anticipated business risks that you are willing to take.
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We design experiments carefully, starting with the representativeness of the active ingredient and its accompanying excipients and packaging: we consider each development stage and, of course, the Target Product Profile (TPP).
Our formulation studies consider relevant stress conditions such as:
- Temperature (intended storage and accelerated conditions)
- Freezing and thawing
- Interfacial stresses related to shaking or shearing
- Surface stresses
We can support liquid or dried (lyophilized) dosage forms for sterile administration, in relevant primary packaging such as vials, cartridges, or syringes.
Administration, Compatibility & Usability
Designing a stable pharmaceutical product is just the start. It must be ensured to deliver medicines easily to the patient (usability and injectability) in the appropriate amount (concentration x volume = dose) and quality (purity, stability), and without any contaminants that may inadvertently have been introduced, e.g. during preparation or handling. The conditions of drug preparation and use may vary significantly from country to country and hospital to hospital, with differing local preferences. These variabilities can provide significant safety and effectiveness challenges in the administration of medicines to patients.
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At ten23 health we support clients in developing an appropriate plan on how to dilute, prepare, and administer the drug to patients, as well as on how to test product quality in simulated lab experiments. In this way, we ensure that dose and quality (purity) meet all expectations, resulting in a safe and effective treatment.
Drug/Device Integration
Product usability is essential. There are various indications and use conditions that benefit from appropriately combining the pharmaceutical product with a suitable delivery device, such as a syringe, autoinjector, or pen, and/or an infusion device. Developing an appropriate formulation for the best administration route, e.g. for subcutaneous delivery or intravitreal injections for treatments of rheumatoid arthritis or Alzheimer disease, may be key for the clinical or commercial success of the product.
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ten23 health supports drug/device combination product development by precisely designing all components of the sterile product: the choice of formulation, primary packaging, manufacturing process, and delivery device.
Molecule Selection & Characterization
Choosing the right molecule as the candidate for clinical development and later commercialization of the product is the key to success.
For example, recombinant proteins can exhibit sequence-based liabilities, such as chemical (e.g., oxidation, deamidation) or physical (e.g., aggregation) degradation pathways, or show undesirable properties such as high viscosity. These may ultimately complicate, or even prevent, developing the medicine towards its target product profile (TPP).
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Our experts can support you in the processes of molecule selection and biophysical characterization, including sequence-based degradation assessments and clinical candidate benchmarking in forced degradation testing.
Imagine having a lysine residue in the CDR of your IgG1, which becomes glycated, rendering your MAB dysfunctional. With our help, this won’t happen.
Analytical Development & Testing
The quality of a pharmaceutical product is determined by its content (impacting dose and hence efficacy and safety), purity (impacting efficacy and safety), and identity.
ten23 health develops, validates, and applies analytical methods to pharmaceutical products with a wide range of active ingredients.
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Our experts use a panel of analytical technologies, such as:
- Content and purity methods such as photometry, HPLC, capillary electrophoresis, icIEF.
- Pharmacopeia testing such as subvisible and visible particles, color, opalescence, pH, osmolality, density, and residual moisture.
- Rheological characterization (viscosity).
- Device and packaging performance such as injectability (e.g., injection break-loose and glide force) or Container Closure Integrity.
- Extended characterization such as Higher Order Structure, surfactant concentration, or degradation testing.
Packaging & Device Characterization
The choice of the appropriate primary packaging and delivery devices for your product is key, especially when dealing with sensitive active ingredients such as biologics.
The drug itself, but also the components of a formulation, and the process conditions for packaging preparation, may interact adversely with the components of primary packaging (e.g., glass vial, rubber stopper, crimp cap) and lead to various issues such as particles, glass delamination, product oxidation, preservative loss, or fogging (for lyophilizates).
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For drug/device combination products, product quality (stability) as well as functionality and usability are crucial. Syringes, autoinjectors, and pumps need to function during the whole product shelf life, within the specified parameters. Injection force and injection time are great examples of functionality. These are highly dependent on formulation viscosity, viscoelastic behavior, and acceptance criteria.
Our experts at ten23 health will advise you effectively on selecting the primary packaging and devices, as well as designing the right experiments.
Molecules Supported
At ten23 health we support clients in sterile product development in a wide range of therapeutic modalities.
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Our expertise covers a high variety of therapeutic modalities, including:
- Monoclonal antibodies
- Bispecific antibodies
- Fragments
- Other types of proteins (e.g., fusion)
- Peptides
- Oligonucleotides (RNA, DNA)
- Conjugates, such as antibody-drug conjugates
- Viral vectors
- Cell therapy
- Other (e.g., exosomes)
In order to achieve systemic exposure, all these modalities must be administered parenterally, i.e., by injection, infusion, or implant into the patient’s body. We support different administration routes (such as intravenous (IV), intra-arterial (IA), subcutaneous (SC), intravitreal (IVT), intrathecal (IT)), product types and dosage forms (such as liquid or lyophilized). We advise on overcoming specific challenges, for example high-concentration formulations, extending the boundaries of what is possible.
We also support Combination Formulations, i.e., combining different modalities into one product, and Drug/Device Combination Products, i.e., a combination of the drug formulation and delivery devices such as syringe, autoinjector, pen, or subcutaneous infusion pump.
Troubleshooting & Regulatory Support
At ten23 health, we love challenges and solving them. If you have any questions or doubts on how to move forward in the development, manufacturing, and testing of your product, or if you have any regulatory questions related to particulates, Container Closure Integrity, product and packaging device interaction or integration for subcutaneous or intravitreal administration, we are here to support you.