Pharmaceutical Product Development

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)

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 development, and dosage forms (such as liquid or lyophilized). Our team of experts offers advice on overcoming specific challenges, for example, high-concentration formulations and extending the boundaries of what is possible.

We also support Combination Formulations, i.e., combining different modalities into one drug product, and Drug/Device Combination Products, i.e., a combination of the drug formulation and delivery devices such as syringes, autoinjectors, pens, or subcutaneous infusion pumps.

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.

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.

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.

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.

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.

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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.

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.

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