Biopharma Group Articles & Resources

Quality by design (QbD) for lyophilisation is about building a robust process that proactively flags critical points and ensures consistent delivery of the best quality product, not only by minimising risk but also through greater understanding of the process itself. Regulatory bodies such as the FDA require details of the lyophilisation cycle

Collagen bio-scaffolds are hugely beneficial to many medical fields and therefore it is essential that the process used to develop them is as robust and viable as possible. Here, Magdalena Witek, Research Scientist at Biopharma, provides an insight into the significance of efficient process optimisation and applications.

Having well trained and informed personnel for your lyophilisation processing helps ensure the best results for your projects, productivity and pocket.

Antibodies-based therapeutics are perhaps the most successful and versatile drug approach developed in the last 30 years. They not only have found application as vaccines and drug carriers but have also been applied to analytical methods such as ELISA (Enzyme-linked Immunosorbent Assay), Wester blotting and flow cytometry.

Years of hard work and research go into developing new APIs, so when it comes to developing one into a new formulation for mass production, careful attention must be paid to its physical and chemical properties. Thorough consideration must go into the excipients to be used, as these can affect how the active ingredient will be released, and they can also react with the API and thereby reduce the product’s shelf life.

Water is generally the main ‘ingredient’ in food and has a considerable impact on both physico-chemical and mechanical properties, which constantly change during storage [2,5]. The products shelf life is limited by the biological activity of microorganisms and water deeply affects it. Bacteria and moulds easily grow and proliferate in humid conditions [2,5], resulting in quicker spoilage and organoleptic degradation [8]. However, not all water present in food has the same influence on the growth of microorganisms [1, 5]. In fact, interaction of water with

As featured in the September 2020 issue of International Labmate (Pages 48-49), please see our latest article authored by Tim Lewis on how Biopharma Group has successfully adapted the freeze drying cycle development process for the production of diagnostic and vaccines in response to the increasing need for fast-turnaround, yet high quality, viable product development to get them to market fast.

2020 proved to be a challenging year in the field of freeze drying/lyophilisation due to the rapidly shifting timelines required to get products to market. This was especially prevalent across the diagnostic and pharmaceutical sectors. In this article, we will be considering why freeze drying is important, how a limited cold chain affects getting products to climate sensitive regions, far from the source of production, and how outsourcing lyo R&D for tackling the freeze drying process efficiently has played such a fundamental part in successfully getting products to end users safer and faster than ever before.