At Affordyne, our focus within large molecule development is centered around peptide-based pharmaceuticals, an exciting and rapidly advancing area of research. Peptides have emerged as highly targeted therapeutic agents offering improved specificity, reduced toxicity, and the ability to modulate complex biological pathways.

Current research in peptide therapeutics is exploring a wide range of applications, including metabolic disorders, cardiovascular diseases, and certain rare conditions. Of particular interest is the development of oral peptide formulations, a field traditionally challenged by poor stability and low bioavailability due to enzymatic degradation and poor intestinal absorption. However, scientific advancements in permeation enhancers, enzyme inhibitors, and novel excipient systems are paving the way for effective oral delivery.

In parallel, sterile injectable peptides continue to play a critical role in treatment regimens where rapid onset and precise dosing are required. Research into depot formulations, sustained-release injectables, and dual-delivery mechanisms is advancing the field toward more convenient and patient-friendly options.

Affordyne closely monitors these innovations and integrates them into its development roadmap. By aligning with cutting-edge research trends in both oral and sterile peptide dosage forms, we are well-positioned to support our partners in bringing novel and effective therapies to market., an emerging and high-impact class of drugs offering targeted action with improved safety profiles. As a Contract Development and Organization (CDO), we specialize in the design, development, optimization, and technology transfer of peptide molecules for pharmaceutical applications.

Peptides, due to their high specificity, low toxicity, and ability to modulate protein-protein interactions, are gaining prominence in areas such as metabolic disorders, oncology, cardiovascular disease, and dermatology. However, peptide development comes with its own set of challenges, including synthesis complexity, stability, and delivery. At Affordyne, we bring deep technical expertise and a science-driven approach to address these hurdles and deliver high-quality, scalable peptide drug products.

Our peptide development capabilities include:

• Peptide synthesis strategy design (solid-phase and solution-phase)

• Sequence optimization for enhanced potency and reduced immunogenicity

• Peptide modification and conjugation, including PEGylation and lipidation

• Formulation development for oral, parenteral, and depot delivery systems

• Solubility and stability profiling

• Analytical method development, including HPLC, LC-MS, and peptide mapping

• Impurity profiling and stability studies in line with ICH guidelines

We place a strong emphasis on optimizing peptides for oral delivery, including technologies such as permeation enhancers, pH-sensitive coatings, enzyme inhibitors, and nanoformulation systems. Our team collaborates closely with excipient providers and technology platforms to explore innovative approaches for enhancing peptide bioavailability.

Affordyne's integrated approach includes early-stage development through clinical supply, supporting:

• Non-infringing strategies and polymorph selection

• Product Development Cost (PDC) modeling for peptides

• Pilot batch manufacturing and process scale-up

• Tech transfer documentation and support to commercial sites

We work in tandem with regulatory and IP consultants to ensure our peptide development strategy is compliant with regulatory guidelines (USFDA, EMA, etc.) and aligned with market exclusivity planning.

Whether you're developing a novel therapeutic peptide or a differentiated generic, Affordyne provides a tailored, science-led pathway from molecule to market. Our in-house R&D, technical know-how, and regulatory alignment make us an ideal partner for the successful development of peptide-based pharmaceutical products., including biologics and biosimilars. Our integrated capabilities span from cell line development to process optimization, analytical characterization, and technology transfer, enabling us to support end-to-end product development.

We begin with robust cell line development, using industry-standard expression systems and screening methods to identify high-yield, stable clones. Our upstream development includes media optimization, bioreactor design, and fermentation strategies, while downstream development focuses on protein purification, yield enhancement, and impurity profiling.

Our process development team uses a QbD-based approach to scale up biologic production efficiently and reproducibly. Affordyne conducts parallel optimization of upstream and downstream processes, ensuring cost-effective, scalable production processes that comply with global regulatory expectations.

In terms of analytical development, we perform a full characterization of biologics, including structural integrity, potency assays, glycosylation analysis, and host cell protein testing. These methods are validated to meet ICH guidelines, and our stability studies are designed to support global regulatory filings.

For biosimilars, we ensure analytical and functional comparability with reference biologics through a stepwise approach aligned with EMA and USFDA guidelines. Our team is experienced in demonstrating equivalence in critical quality attributes, setting the foundation for regulatory success.

Our services also include:

• Preclinical and toxicology support

• Formulation development and lyophilization

• GMP-compliant manufacturing for clinical phases

• IND/IMPD preparation and regulatory strategy

• CMC documentation for global submissions

Our infrastructure supports tech transfer to full-scale GMP manufacturing facilities. We collaborate closely with clients to ensure seamless transitions and alignment with project milestones.

At Affordyne, we understand the complexities and regulatory rigor involved in large molecule development. Our scientific excellence, compliance culture, and commitment to innovation make us a trusted partner for delivering biologic therapies from lab to clinic and beyond.