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.
Tab.1 Applications of different live probiotic bacteria for various therapeutic purposes. (Islam, 2010)
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.
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.
For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.
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