Formulation Development Service for Therapeutic Antibody and Protein

Development Process Our Services Highlight Related Services

Medical Capsule and Transparent Cell, the schematic of Formulation. (Creative Biolabs Authorized)

In the development of therapeutic antibodies and proteins, to bridge the critical gap between the discovery stage and the final release to the market, formulation development represents a central link in the manufacturing process and plays a key role in guaranteeing the stability, efficacy and quality of a therapeutic antibody or protein throughout its lifecycle, from production to delivery. With proteins and antibodies representing the largest biologics category, their formulation development typically requires a highly customized approach, as protein stability (either chemical or physical), solubility, and bioactivity can be crucially affected by various factors. At Creative Biolabs, formulation development aims to maintain the therapeutic potential of your biologic while reducing the probability of aggregate formation, denaturation, and unwanted immunogenic responses.

Creative Biolabs offers one-stop-shop services for a series of important protein-based therapeutics such as monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, recombinant proteins, fusion proteins, growth factors, cytokines, human blood factors, and colony-stimulating factors. The formulation development for liquid dosage forms and lyophilized powders is performed by integrating with relevant container closure systems such as vials, stoppers and caps or syringes and the drug product process manufacturing design.

Key Stages of Formulation Development

01 Preformulation Studies

Preformulation studies establish the base of the pyramid by assessing the physicochemical characteristics of the biologic, including important parameters such as pH stability, solubility, and thermal stability (which is important for lyophilized drugs). Analytical characterization procedures such as Differential Scanning Calorimetry (DSC) and Dynamic Light Scattering (DLS) can be used to determine or confirm optimal formulation conditions by exposing the molecule to several different conditions. Such techniques can reveal the possible degradation pathways and identify the necessary excipients or stabilizers for the formulation.

02 Development of Candidate Formulations

Then comes the formulation stage where the preferred antigen is assessed as a liquid, frozen or lyophilized formulation depending on stability outcomes from earlier preformulation studies. Quality by Design (QbD) principles applied at Creative Biolabs make sure that critical quality attributes (CQAs) are established well. This guarantees control of the later development and manufacturing processes.

03 Optimization for Clinical and Commercial Use

Once the candidate formulations have been identified, they are subjected to stress-testing under multiple manufacturing, storage and transport conditions, from freeze-thaw cycles in 'real-world' weather extremes and accelerated to high temperature to predict long-term stability. At this stage, manufacturability is also guaranteed so that the process for scaling up to industrial quantities also works.

04 Regulatory Considerations

This is especially important in the context of ICH stability studies, which examine if the biologic can withstand all the different tests it might be in during its intended lifecycle. Without this kind of data, you can't submit it for regulatory approval. Lots of formulation testing is required for approval, and it all needs to be documented.

Fig.1 Comprehensive Services for Developing Formulation at Creative Biolabs. (Creative Biolabs Original) Fig.1 End-to-end Formulation Development Services.

Formulation Development Services

Comprehensive Pre-Formulation & Formulation Support

Creative Biolabs provides integrated pre-formulation and formulation development, aligning early-stage clone selection and process development with downstream formulation requirements. This ensures a streamlined workflow from initial drug discovery to final formulation.

High-Throughput Screening Tools for Rapid Screening

Utilizing cutting-edge High-Throughput Screening (HTS) technologies like MFI, DSC, and DLS, Creative Biolabs performs rapid screening of excipients and buffers. These techniques enable early identification of optimal conditions for product stability, bioactivity, and solubility.

Design of Experiment (DOE) for Optimization

The DOE approach identifies critical formulation variables and optimizes these conditions to ensure the highest product quality and performance. This predictive methodology minimizes development timelines and maximizes formulation robustness.

Integrated Stability Testing

Forced degradation studies and ICH-compliant stability assessments, including accelerated and long-term studies, ensure that formulations maintain stability under various storage and handling conditions. These tests prevent future product failures and enhance regulatory readiness.

Advanced Fill-Finish Development & Scale-Up

Creative Biolabs excels in compounding and fill-finish development, evaluating variables such as mixing, holding times, and filling rates. The expertise in developing processes for pre-filled syringes and lyophilized products ensures compatibility with both manufacturing and patient delivery needs.

Technical Transfer & Manufacturing Support

With extensive experience in technical transfer and manufacturing scaling, we ensure seamless transitions from development to commercial production. This includes comprehensive support for compounding, filling, and scaling up processes to meet regulatory compliance standards.

Cutting-edge techniques and Automation in Formulation Development

Automation in Formulation Screening

Creative Biolabs utilizes high-throughput systems to increase the speed of formulation development. These technologies allow for simultaneous assessments of several formulations while reducing the time and resources spent on arrival at the optimal formulation. Microfluidic chips also offer low-volume analysis capabilities, especially when therapeutic proteins are limited in quantity.

Incorporating Computational Tools

Predicting the immunogenicity or interaction of your drug in the body is also becoming more reliant on deep learning algorithms, or clandestine molecular dynamics (MD) simulations. By running simulations of the interaction of the protein with excipients, we can predict how changes to formulation variables will impact on overall stability and efficacy of your product.

Emerging Trends in Formulation Development

PEGylation

Polyethylene glycol (PEG) bound to proteins can boost their half-life, reduce immunogenicity, and improve pharmacokinetics.

Glycoengineering

By applying artificial genetic control to glycosylation patterns we can enhance the stability or activity of a therapeutic protein.

Cross-linked Polymers

Cross-linked polymers encapsulate proteins for controlled release and prolonged protection from degradation, increasing the therapeutic's effectiveness.

With senior scientists and extensive experience, Creative Biolabs has established one of the world's largest and experienced formulation development team to facilitate your therapeutic protein product development. We are dedicated to assisting your program in the most efficient and cost-effective manner. Please contact us for a flexible and customized solution.