Whitepaper
Visible Particulate Isolation and Identification: A Case Study
Resource Overview
Particulate matter can originate from multiple sources throughout pharmaceutical manufacturing, making rapid and reliable identification important for understanding its potential origin and addressing manufacturing challenges. While many facilities rely on external laboratories for particle isolation and identification, Simtra has an onsite team that works to provide identification data within 24 hours, helping manufacturing teams quickly investigate observed particulates and determine next steps.
This whitepaper explores Simtra’s approach to particle isolation and identification, including potential sources of particulate matter and how analytical data and process knowledge can support investigations. It also examines how particulate trending and continuous improvement can strengthen contamination control and help protect product quality.
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Whitepaper
Dual Approach to Formulation Development
Simtra’s dual approach to formulation development is designed to efficiently determine whether a drug is best suited for a solution or lyophilized presentation. Using an antibody-drug conjugate (ADC) as an example, this whitepaper explores how early studies and accelerated stability data can help identify the best formulation candidate to advance. Gain insight into how an...
Whitepaper
Lyophilization Process Development for Antibody Drug Conjugates
Lyophilization is a critical technology for stabilizing ADCs and enabling their clinical and commercial success. A systematic, science-based approach integrating formulation development, process design and analytical characterization ensures a robust and scalable manufacturing process. Leveraging deep expertise in lyophilization and analytical characterization, along with a quality-by-design framework, Simtra BioPharma Solutions can effectively support process development...
Whitepaper
The Effect of Conventional Cooling Versus Controlled Ice Nucleation on Primary Drying Time Overview
This whitepaper investigates how shelf cooling rates influence supercooling behavior and mass‑transfer efficiency during the freeze‑drying process. It explains why slower cooling rates often lead to higher degrees of supercooling, resulting in smaller ice crystals and increased resistance to mass transfer—factors that can prolong primary drying and affect overall process performance. The paper also examines...
Whitepaper
Nucleation Temperature Overview
This whitepaper explores how controlled ice nucleation can significantly influence freeze‑drying performance, with a particular focus on drying time. It provides a detailed examination of the relationship between formulation characteristics and the ice nucleation process, highlighting how intentional control of nucleation temperature can lead to more consistent ice crystal structures and improved process efficiency. In...
Whitepaper
Considerations and Options for Prefilled Syringes
Convenience, product differentiation, and less waste are great reasons for developing a parenteral product in a prefilled syringe. Prefilled syringes are ready to use without the need for dilution, require significantly less overfill compared to vials, and often present a more cost-effective option for high-value medications. In this whitepaper, learn more from the Simtra BioPharma...
Whitepaper
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...
Whitepaper
Vial Breakage During Lyophilization
Lyophilization, a freeze-drying technology that improves the stability of injectable pharmaceuticals, is often used to enable cold storage in a product’s solution form. The process involves freezing of a formulation, removal of water vapor through sublimation under reduced pressure, and removal of unfrozen water during secondary drying. Formulations are filled in glass vials of varying...
Whitepaper
Manufacturing of Cytotoxic and Non-Cytotoxic Drugs in a Multiproduct Facility
With the advent of more product niches and often lowered production quantities, facilities that are experienced and versatile in handling cytotoxic, highly potent, and non-cytotoxic oncology products can present a valid option when considering outsourcing. Risks for cross-contamination must be properly assessed, using state-of-the-art organization procedures, technical standards, and current industry guidance. Ultimately, patient safety...
Whitepaper
Bringing your Sterile Injectable Product to Market: Considerations for Collaborating with a Fill/Finish CMO
With increased market expectations and new, more stringent regulatory hurdles, for many, establishing a partnership with the right contract development and manufacturing organization (CDMO) is more cost effective than investing internally in their own infrastructure. Selecting the “right” outsourcing partner is a strategic priority for pharmaceutical and biotech companies seeking to get their product to...
Whitepaper
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....
Whitepaper
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...
Whitepaper
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...
Whitepaper
Best Practices in Formulation and Lyophilization Development
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...
Whitepaper
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...
Whitepaper
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...
Whitepaper
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...
Whitepaper
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...
Whitepaper
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...
Whitepaper
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...
Whitepaper
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...
Whitepaper
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 21 now approved worldwide and more than 350 in clinical development. Because the antibody is generally less stable than the small-molecule cytotoxic agent, 90% of commercially available...