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.
Formulation Development Service for Therapeutic Antibody & Protein
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.
Introduction What We Can Offer How We Can Help Why Creative Biolabs Customer Reviews FAQs Contact Us Related Services
Tailored Formulation for Advanced Protein Therapeutics
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.
Collaborate with our experts to develop a tailored solution for your program - Request a consultation.
Fig.1 An integrated approach to formulation development of therapeutic antibody and protein.
What We Can Offer
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.
How Creative Biolabs' service Can Assist Your Projects
Preformulation Studies
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 ensure that critical quality attributes (CQAs) are well-established. This guarantees control of the later development and manufacturing processes.
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.
Regulatory Considerations
This is especially important in the context of ICH stability studies, which examine whether 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.2 End-to-end formulation development services.
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 the 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. |
Leverage our strategic partnership to expedite your research and development timeline - Get a quote today.
Customer Reviews
-
Reduced Aggregation
Using Creative Biolabs' formulation development service in our research has significantly improved the long-term stability of our bispecific antibody candidate, specifically by reducing aggregation below the critical sub-visible particle threshold identified via MFI. This saved us months of re-engineering. - J**n S*h. -
High Concentration Success
The viscosity modeling provided by Creative Biolabs allowed us to hit a target concentration for our Fc-fusion protein - a concentration we previously thought impossible - without compromising process flow dynamics. Their understanding of protein-protein interactions is superior to that of other contract labs. - M**k L**e.
FAQs
What is the primary advantage of Creative Biolabs' approach compared to a generic CRO service?
Our advantage lies in our use of quality by design (QbD), coupled with advanced high-throughput automation. Instead of testing conditions linearly, we use DoE to efficiently map the design space, leading to more robust, scientifically justified formulations and dramatically reducing the overall development timeline.
My protein is highly concentrated for high-dose delivery. Can you solve the high viscosity issues?
Yes. We specialize in high-concentration formulation (HCF). We employ advanced rheological analysis and screening of viscosity-reducing excipients (e.g., specific amino acids and salts) to modulate protein-protein interactions, ensuring your high-dose product exhibits optimal process flow and high stability.
How to Contact Us
With senior scientists and extensive experience, Creative Biolabs has established one of the world's largest and most experienced formulation development teams to facilitate your therapeutic protein product development. We are dedicated to assisting your program most efficiently and cost-effectively. Please contact us for a flexible and customized solution.
Related Services
Download our brochureLoading case studies...
Online Inquiry