Microbial formulation services are available for liquid and lyophilized product dosage forms. They have been integrated into the development of the live biotherapeutics products (LBPs) formulation, substance composition, and container closure systems such as vials, stoppers, and caps or syringes. LBPs microbial formulation process and adequate target product profile can ensure quality, compliance, usability, and competitiveness of the product being developed. Creative Biolabs' team is highly skilled in microbial formulation services, including lyophilization development services and stability development services.
Fig.1 Summary of the basic principles for the most commonly applied drying techniques.1
About 25% of new injectable drugs, vaccines, and biological products are formulated in a lyophilized form, and for many proteins, peptides, and vaccines, this represents the preferred way to produce stable, biologically active products with a long shelf-life. Lyophilization involves manipulating the temperature and pressure of the solution so that the phase of the solution can move directly from the frozen state to the gaseous state without moving through the liquid phase/state. The advantages of lyophilization include enhanced product stability in a dry state, enhanced stability of a dry powder, ease of processing a liquid as opposed to a powder fill, which simplifies aseptic handling, and removal of water without excessive heating of the product, rapid and easy dissolution of reconstituted product.
Stability studies ensuring the maintenance of product quality, safety, and efficacy throughout the shelf life are considered a prerequisite for the acceptance and approval of any pharmaceutical product. The most important steps during the developmental stages include pharmaceutical analysis and stability studies that are required to determine and assure the identity, potency, and purity of ingredients, as well as those of the formulated products. Stability testing is termed a complex process because of the involvement of a variety of factors influencing the stability of a pharmaceutical product. The stability of a pharmaceutical product can also be affected because of microbiological changes like the growth of microorganisms in non-sterile products and changes in preservative efficacy.
Unlock the potential of your product with our Formulation Development & Quality Establishment Services. This comprehensive offering is designed to take your active ingredients from concept to a commercially viable and stable product. We specialize in:
a) Developing optimal product formulations (e.g., tablets, capsules, liquids, creams) that ensure efficacy, safety, and patient compliance.
b) Establishing robust quality standards and testing methods that comply with regulatory requirements. This includes analytical method development, validation, and stability studies to guarantee the consistency and shelf-life of your final product.
By focusing on both the science of formulation and the rigor of quality assurance, we streamline your path to regulatory approval and successful market launch. Click to explore how we can expertly craft and qualify your product for success.
Highlights of Microbial Formulation Services
-
Purification development.
-
Complex assay method development and validation for the quantification of LBPs, metabolites, and biomarkers.
-
Whole-genome sequencing, transcriptomics, proteomics, phospho-proteomics, and immunohistochemistry.
-
Microbial formulation services, including lyophilization development services, and microbial biomass isolation services.
Why Choose Creative Biolabs' Microbial Formulation Services?
-
We have a good relationship with various suppliers to meet your order requirements at any time.
-
We take the time to listen to you and understand what you would like your product performance-wise.
-
Our scientists provide services for a range of LBPs and have the experience necessary to effectively formulate a high-performing and competitive product.
-
Our highly skilled team is experienced in designing an appropriate and cost-efficient development strategy, enabling fast development timelines with appropriate quality and mitigation strategies.
Creative Biolabs helps businesses and entrepreneurs to create new products and redefine/innovate their existing ones. As biological products become more and more complex and freeze-drying becomes more and more challenging, the control of nucleation will become an essential technology. Our scientists provide services for a range of LBPs and have the experience necessary to effectively formulate a high-performing and competitive product. We are pleased to help more customers overcome future challenges. Please contact us for more scientific support.
Reference
-
Kiepś, Jakub, and Radosław Dembczyński. "Current trends in the production of probiotic formulations." Foods 11.15 (2022): 2330. Distributed under Open Access license CC BY 4.0, without modification.
