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Project Description

Please note that we are a research service provider, not a pharmacy or clinic, so we are unable to see patients and do not offer diagnostic and treatment services for individuals.

Therapeutic Protein Development Service

Ophthalmic diseases are treated with therapeutic proteins which are specialized biologics meant for the therapeutics of eye disorders. Our company, Protheragen, focuses on the propriety development of therapeutic proteins for ophthalmic diseases by utilizing our skills in biotechnology and pharmaceutical sciences.

Introduction to Ocular Therapeutic Protein

Therapeutic proteins refer to specific proteins such as antibodies, enzymes, and growth factors that are biologically engineered for the therapeutics of certain diseases by interacting with distinct cellular pathways. They are produced using recombinant DNA technology which guarantees their accurate application in treating cancer, autoimmune disorders, and many more. Unlike small-molecule drugs, these therapeutic proteins have high specificity as they interact with natural biological processes. Their interaction with disease-specific targets greatly assists modern medicine.

Biodegradable and nonbiodegradable implants for the delivery of therapeutic proteins to the eye.

Fig.1 Biodegradable and nonbiodegradable implants for ocular delivery of therapeutic proteins. (Shastri D. H., et al., 2023)

Therapeutic Protein Development for Ophthalmic Disease

Marketed anti-VEGF medications lead the field of ophthalmic therapeutic proteins, which is constantly developing. Issues like immune response, short half-life, and frequent injections continue to present problems. Some solutions include sustained-release systems, gene therapy vectors such as RGX-314 for wet AMD, and new targets such as complement inhibitors like pegcetacoplan. Other trials also try bispecific antibodies and fusion proteins to consolidate therapeutic effectiveness. There has been progress, but less invasive delivery methods and greater therapeutic scope are still priorities in research.

Table 1. Examples of different approaches used to improve the bioavailability of ocular therapeutic proteins. (Shastri D. H., et al., 2023)

Approaches	Remarks
Use of penetration enhancers	Increases corneal permeability.
Improve enzymatic resistance	Avoids degradation by enzymes present in ocular tissues.
Conjugation Approaches
Conjugation with ligand, lipids, melanin, hyaluronan, and PEG	Enhances half-lives, diminishes immunogenicity, safeguards macromolecules, averts proteolytic breakdown, and ensures long-term stability. Boosts membrane permeability.
Conjugation with ligands	Targeted delivery to specific tissues, achieving low toxicity and minimal systemic exposure.
Formulation Approaches
Hydrogels	Protect molecules from degradation and provide long-term release.
Mucoadhesive polymeric system	Achieve site-specific drug delivery. Improves permeation.
Micro/Nanocarriers	Safeguard molecules against enzymatic breakdown. Boost permeability. Ensure controlled drug release specifically in the desired ocular region. Act as a depot to prolong retention of the formulation. Enhance physical stability. Augment drug permeation.
Cell-Penetrating Peptides	Enhance penetration through ocular barriers and achieve sustained release by inhibiting degradation and prolonging drug residence time.
Iontophoresis	Enhances permeation and facilitates the transfer of ionized molecules across biological membranes to ocular tissues via low electric current.
Encapsulated Cell Technology	Enzyme protection, stability, long-term release.
Microneedles	Enable passive diffusion of therapeutic agents, bypassing the transport barriers of epithelial tissues, circumventing clearance via conjunctival mechanisms, and reducing retinal damage.
Implants	Safeguard against degradation and deliver a slow, sustained, and constant-rate release over an extended period through a depot formulation.

Our Services

Through comprehensive services, innovative technologies, and customized solutions, we accelerate the development of therapies for our customers in the field of ophthalmology.

Target Identification & Validation

Bioinformatics analysis of ocular disease pathways.
In vitro and in vivo target screening using disease-relevant models.

Protein Engineering & Optimization

Affinity maturation, stability enhancement, and deimmunization.
Species-specific optimization for preclinical testing.

Cell Line Development & Protein Production

CHO, HEK293, and microbial expression systems.
High-yield, scalable production under GMP-like conditions.

Formulation & Stability Testing

Development of intravitreal, topical, and sustained-release formulations.
Accelerated stability studies under ICH guidelines.

Preclinical Studies

Efficacy testing in animal models.
Pharmacokinetics (PK) and drug safety studies.

Types of Therapeutic Protein Development

Fusion Protein Development

We engineer fusion proteins combining therapeutic domains (e.g., VEGF traps) with Fc regions or half-life extenders (e.g., albumin-binding domains) to enhance ocular bioavailability.

Recombinant Protein Development

Our recombinant protein development services leverage state-of-the-art techniques to produce proteins with high yield and quality, such as enzymes, transmembrane proteins, viral antigens, kinases, etc.

At Protheragen, we integrate cutting-edge science with industry-leading expertise to accelerate the development of next-generation ophthalmic therapeutic proteins, delivering safer, more effective therapeutics for vision-threatening diseases. If you are interested in our services, please feel free to contact us.

References

Shastri, Divyesh H., Ana Catarina Silva, and Hugo Almeida. "Ocular delivery of therapeutic proteins: a review." Pharmaceutics 15.1 (2023): 205.
Akash, Muhammad Sajid Hamid, et al. "Development of therapeutic proteins: advances and challenges." Turkish Journal of Biology 39.3 (2015): 343-358.