Microbial Formulation Services

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, 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 microencapsulation services.

Applications of different live probiotic bacteria for various therapeutic purposes. Tab.1 Applications of different live probiotic bacteria for various therapeutic purposes. (Islam, 2010)

  • Lyophilization Development Services
  • 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, removal of water without excessive heating of the product, rapid and easy dissolution of reconstituted product.

  • Microencapsulation Services
  • Scientific research regarding the use of live bacterial cells for therapeutic purposes has been rapidly growing over the years and has generated considerable interest to scientists and health professionals. Owing to their considerable beneficial health effects, these microorganisms are increasingly incorporated into dairy products; however, many reports have demonstrated their poor survival and stability. To overcome these problems, microencapsulation techniques are currently receiving considerable attention. Microencapsulation is defined as a technology of packaging solids, liquids, or gases, obtaining as a result thereof tiny particles or droplets surrounded by a coating, called microcapsules. In a relatively simple form, a microcapsule is a small sphere or fiber of an active substance container (diameters are between a few micrometers and a few millimeters) with a uniform, micro-porous, and semi-permeable wall around it. The material inside the microcapsule is referred to as the core, internal phase, or fill, whereas the wall is sometimes called a shell, coating, or membrane. These microcapsules are inserted into final products to get the added-value that makes the difference concerning the competence.

  • Dosage Form Development
  • The pharmaceutical industry constantly designs and develops new drug products, and improves its product development Processes. Formulation and drug-delivery technologies play an important role in new product development. The development from the initial formulation design up to the final form and its translation to the market involves substantial labor time, cost, energy, and raw materials consumption. An adequate selection of components and technology for the development of a formulation is required to meet high product quality expectations. These factors have a direct impact on the evolving microstructure which in turn likely affects the attributes of the final dosage form such as tablet hardness, disintegration, or dissolution profile.

  • Stability Development
  • Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite 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 as 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.

Our Capabilities

  • Purification development
  • Formulation and aseptic filling
  • Custom packaging
  • Complex assay method development and validation for the quantification of LBPs, metabolites, and biomarkers
  • Providing information on vectors, cell lines, antibody, recombinant proteins, assay kits, and other reagents or data
  • Whole-genome sequencing, transcriptomics, proteomics, phospho-proteomics, and immunohistochemistry
  • Microbial formulation services, including lyophilization development services, microbial biomass isolation services, microencapsulation services.

Why Us?

  • 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

  1. Islam, Ariful. M. Microencapsulation of Live Probiotic Bacteria. Journal of Microbiology & Biotechnology. 2010, 20(10): 1367-1377.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.

Services

Online Inquiry

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.

Contact us

Contact us

Copyright © 2022 Creative Biolabs. All Rights Reserved.

Inquiry Basket