Pharmaceutical Product Development

ten23 health supports pharma & biotech clients in designing their Target Product Profile (TPP) and the best Chemistry, Manufacturing & Controls (CMC) roadmap, from preclinical through clinical and also towards the commercial stage.

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, managing and mitigating development risks. We provide stage-appropriate formulation services, 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 sound knowledge of the development process in the pharmaceutical industry, broad scientific expertise, as well as extensive regulatory experience. We perform all necessary experiments, ensuring regulatory compliance and patient safety at all stages of drug product design.

Learn more on our lean strategies:

-Early stage Formulation Development: to enable moving molecules quickly, but with adequate quality,  into Toxicology, Phase 1, and Proof of Concept (PoC) study services for clinical trials (early stage) - - considering the overall commercialization strategy. 

-Late stage and commercial Formulation Development: executing full development scopes, including Quality-by-Design (QbD) and design space-based filings, interaction studies, for ensuring robust products for commercial launches (late stage).

-Line extension formulations: developing improved product versions, e.g., subcutaneous formulations for intravenous commercial products, that may also enable life cycle management for sterile products. 

Learn more on our pharmaceutical process design:

In our pharmaceutical design process, we meticulously plan our experiments, starting with the representativeness of the active pharmaceutical ingredient (API) 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 in any pharmaceutical design such as:

• Temperature (intended storage and accelerated conditions)
• Freezing and thawing
• Interfacial stresses related to shaking or shearing
• Surface stresses

In terms of parenteral drug development, we can support liquid or dried (lyophilized) dosage forms for sterile administration, in relevant primary packaging such as vials, cartridges, or syringes.

Designing a stable pharmaceutical product is only the beginning. The development process must be designed to ensure an easy delivery to the patient, in terms of usability and injectability,  in the appropriate quantity (concentration x volume = dose) and quality (purity, stability), and without any contaminants that may have been inadvertently introduced, e.g. during preparation or handling. The conditions of preparation, administration, and use of drug products may vary significantly from country to country and hospital to hospital, with differing local preferences. These variations can pose significant challenges to the safety and efficacy of drug delivery to patients.

At ten23 health we help our clients develop an appropriate plan on how to dilute, prepare, and administer the drug product to patients, as well as on how to test drug 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 for the patient.

Drug 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, pen, and/or an infusion device. The drug product process development involves selecting optimal administration routes, such as subcutaneous delivery, which are crucial for the clinical or commercial success of treatments for conditions like rheumatoid arthritis or Alzheimer's disease or intravitreal injections, which treat diseases like AMD or Glaucoma.

ten23 health's product development strategy services for the pharmaceutical industry support the development of drug-device combination products by precisely designing all components of the sterile product: the choice of the pharmaceutical product formulation, the primary packaging, the manufacturing process, and the delivery device.

Choosing the right molecule as the candidate for clinical development and later commercialization of the drug 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).

Our experts can support you throughout the pharmaceutical product development process, from molecule selection and biophysical characterization, to sequence-based degradation assessments and benchmarking of clinical candidates in forced degradation studies.

Imagine you have lysine residue in the CDR of your IgG1, which becomes glycated, rendering your monoclonal antibody (mAb) dysfunctional. With our help, that´s not going to happen.

Researchgate

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.

The choice of the appropriate primary packaging and delivery devices for your drug product is key, especially when dealing with sensitive active pharmaceutical ingredients such as biologics.

The drug product itself, but also the components of a pharmaceutical 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, pharmaceutical product oxidation, preservative loss, or fogging (for lyophilized products).

For drug/device combination products, product quality (stability) as well as functionality and usability are crucial. Syringes, autoinjectors, and pumps must function within specified parameters throughout the shelf life of the drug product. Injection force and injection time are important 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 the selection of the primary packaging and devices, as well as the pharma design of the right experiments.

Find out more on our approach in predicting glass vial fogging in lyophilized drug products Read Case Study