Whitepaper
Best Practices in Formulation and Lyophilization Development
Resource Overview
The ultimate goal of formulation development is a stable product. In the case of a protein product, that can be defined as delivering the correct dose, in the native secondary and tertiary structure, without unintended chemical modifications, and free of extrinsic and intrinsic particles. In many cases, a lyophilized formulation can provide the highest probability of technical success. A well-designed product development plan can develop a Phase 1 product quickly, while laying the foundation for commercial product success.
In this whitepaper learn more from the Simtra BioPharma Solutions team on best practices for formulation development, with a focus on creating stable pharmaceutical products.
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Importance of Assessing Mannitol Crystallinity in Lyophilized Drug Products
Mannitol is a versatile excipient used in freeze-dried injectables in the pharmaceutical industry. Depending on the freezing and/or annealing conditions employed, mannitol is retained either as amorphous or crystalline. Crystalline mannitol is more prevalent in drug product formulations than amorphous mannitol. When crystalline, it provides an opportunity to conduct lyophilization cycles at aggressive conditions due...
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Vial Breakage During Lyophilization
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Manufacturing of Cytotoxic and Non-Cytotoxic Drugs in a Multiproduct Facility
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Bringing your Sterile Injectable Product to Market: Considerations for Collaborating with a Fill/Finish CMO
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Is Mannitol Hemihydrate Detrimental to Protein Stability?
Maintaining an amorphous excipient matrix is crucial for protein stability in freeze-dried pharmaceuticals. The high propensity to crystallize during freezing and its high eutectic temperature make mannitol an attractive bulking agent in lyophilized pharmaceuticals. However, mannitol, a widely used excipient, can form a metastable polymorph called mannitol hemihydrate (MHH) during freeze-drying, potentially impacting protein stability....
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Solid State Hydrogen Deuterium Exchange to Study Antibody-Drug Conjugate Stability
Antibody drug conjugates (ADCs) have emerged as a leading option in cancer therapy due to their targeted specificity and minimal side effects and toxicity. Given the low bioavailability and the instability of the linker connecting the antibody and the chemotherapeutic agent, these drugs are typically developed in a lyophilized form. To assess the stability of...
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Factors to Consider While Selecting Stoppers for Lyophilized Vials
Lyophilization is a common method for stabilizing parenteral drugs with poor solution stability. Beyond formulation and process development, a robust container-closure (c/c) system is essential to ensure the success of the lyophilized product. Pharmaceutical rubber closures play a critical role in preserving the drug’s integrity by acting as barriers against moisture, air, and oxygen. During...
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Methods for Determining Equipment Capability of Freeze-Dryers
Lyophilization is a drug manufacturing process that involves freezing the formulation, drying the frozen ice under vacuum, and subsequent removal of unfrozen residual water. The pharmaceutical freeze-drying technique is constantly evolving to achieve improvements through a better understanding of the product and process conditions and the efficiency of the equipment. This white paper describes two...
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Leak Rate Testing for Freeze-Dryers
Assurance of the vacuum integrity of freeze-dryers used for the manufacture of sterile pharmaceutical products is essential for GMP operations. However, there is currently no generally accepted scientific rationale for establishing acceptance criteria for such testing, and current acceptance criteria are generally based on equipment capability. In this whitepaper learn more from the Simtra BioPharma...
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Stopper Migration in Frozen Pre-Filled Syringes
Parenteral products provided as pre-filled syringes (PFS) offer unique benefits to both the patient and manufacturer. Because the closure system – i.e. plunger – is inherently mobile, environmental factors must be considered to ensure that the sterility of the product is maintained during storage, transport, and handling before administration. Chief among these factors are temperature...
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Process Development for Lyophilized Products
The process development for product lyophilization includes a number of critical stages, such as freezing, primary drying, and secondary drying. This whitepaper outlines strategies for enhancing efficiency and stability in the lyophilization cycle while also addressing the management of residual moisture to ensure product quality. In this whitepaper learn more from the Simtra BioPharma Solutions...
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Scale-Up and Tech Transfer
Formulation and process development for injectable products are typically conducted at laboratory-scale. There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilization. There can be differences in design of lyophilizers at laboratory-scale and at full-scale and also between full-scale...
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Seasonal Vaccine Manufacturing
The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting from annual strain selection. While service directories are filled with CMOs claiming vaccine fill-finish experience, the logistical challenges resulting from seasonal product are unique and it is important that outsourcing partners can ensure...
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Vial Fogging: Practical Considerations for Vial Selection
Vial fogging is a common phenomenon observed in lyophilized biologic drug products, characterized by a haze of dried powder forming above the cake’s surface inside the vial. This haze can appear as a dendritic pattern, branching, or a uniform fog. While often considered a cosmetic defect, severe fogging can lead to the costly rejection of...
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Lyophilization Development for Antibody-Drug Conjugates (ADCs)
With their ability to deliver precisely targeted therapies for a growing number of cancer types, it’s no wonder that the development and approval of ADCs is expanding, with 17 now approved worldwide and more than 100 in development. Because the antibody is generally less stable than the small-molecule cytotoxic agent, 90% of commercially available ADCs...