Click the links below to download key Articles in PDF format:
1. What Does the “Current” in Current Good Manufacturing Processes (cGMP) Mean?
LuinaBio has actively invested the appropriate resources over time to remain “current” under cGMP. In addition LuinaBio uses a proactive approach to cGMP to ensure for all our clients that the products that we make for them are safe, pure, and effective. LuinaBio uses systems and equipment to prevent contamination, mixups, and errors, that is not only up-to-date but that is “top-of-the-line.” In this article we share what the “current” in current Good Manufacturing Practices (cGMPs) mean and how we remain current according to international standards.
2. ISO Standards for the Fermentation & Isolation of Medicinal Products
LuinaBio’s use of ISO health standards provides tools to assess and evaluate conformity and ensures consistency for our clients. ISO standards safeguard consumer interests by ensuring good quality care and safe and reliable products and services. In this article we share the meaning of the ISO classifications and what each ISO class represents in terms of cleanliness.
3. Fermentation and Protein Biomanufacturing
Drawing on more than 15 years of contract manufacturing experience, LuinaBio scientists have the expertise, training and experience to ensure a successful outcome to any biomanufacturing project.
In the past, we have manufactured recombinant proteins, whole cell vaccines, viral vaccines, purified plant extracts, pro-biotics and synthetic molecules for pre-clinical, phase 1 to 3 human clinical trials, and commercial veterinary products for clients both within Australia and internationally in the United States, New Zealand and Asia. In regards to biological molecules, LuinaBio has an expertise in the production and purification of biopharmaceuticals (also called “biologics”) from the fermentation of bacterial and yeast cell lines. Protein or carbohydrate biological molecules can be produced that way. In this article we share some details on some of the common bacterial host systems we use.
4. API Contract Manufacturing
In order to clearly understand active pharmaceuticals contract manufacturing an understanding of terminology is of prime importance. The first term to understand is what is meant by “active ingredient” in API Contract Manufacturing. This article describes what an active ingredient is and what substances are manufactured under different processes.
5. Custom Chemical Synthesis
Active Pharmaceutical Ingredients (APIs) are the active substances used in the formulation of final drug products and these final formulations can have a single API or multiple APIs. APIs can be manufactured by processes such as (1) chemical synthesis; (2) fermentation; (3) recombinant DNA or other biotechnology methods; (4) isolation/recovery from natural sources; or (5) any combination of these processes. LuinaBio has core competencies in all of these technologies and particularly in custom chemical synthesis. In this article, we share what we offer our clients in custom chemical synthesis.
6. Vaccines Contract Manufacturing
Scientists take many approaches to designing vaccines against infectious agents. These choices are typically based on fundamental information about the microbe, such as how it infects cells and how the immune system responds to it. Practical consideration are also taken into account, such as regions of the world where the vaccine would be used. This article shares some of the following options that are available for designing vaccines.
7. The Extraction and Purification of Natural Products
In addition our chemical synthesis and biopharmaceutical manufacturing services, LuinaBio has capabilities in natural products extraction, purification and characterisation. A “natural product” is a chemical compound or substance produced by a living organism that is found in nature. Natural products may be produced by the chemical extraction of plant or animal tissues followed by isolation and purification of the final product. In this article, we share more information on how natural products are isolated and produced.
8. Advantages and Challenges in Australian Biomanufacturing
There are many reasons to manufacture biologics in Australia. One is that the large number of mutual recognition arrangements that exist with Australia and key international regulatory authorities. For example, the US Food and Drug Administration (FDA) has signed a Memorandum of Understanding (MOU) with the Australian Therapeutics Goods Administration (TGA) which allows the two organizations to exchange information on Good Manufacturing Practice (GMP) inspections of pharmaceuticals facilities. This represents a streamlined approval process for Australian-based pharmaceutical companies seeking to market their products in the US. This article shares why you should be looking at Australia to do your biomanufacturing.
9. Quality in Contract Biomanufacturing
LuinaBio takes pride in providing a quality manufacturing service to an international standard. LuinaBio has a total quality assurance system developed and inspected in accordance with local and international requirements. The LuinaBio facility follows the international GMP guidelines as set out in the (PIC/S) “Guide to Good Manufacturing Practice for Medicinal Products Part II (PIC/S 009-8). Australia is also a founding member state of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) resulting in Australian Therapeutics Goods Administration (TGA) guidelines being adopted internationally. In this article we share in detail our licenses and guidelines we follow for key quality management principles.
10. Client Support Services Offered by Contract Manufacturers
Technical expertise is always critical in the decision about which CMO to partner with to provide manufacturing solutions. However other key variables of importance that distinguish the best CMOs are timelines, efficiency, flexibility and related organizational expertise. This article explains our client support services we offer.