Biopharma Group Articles & Resources

August 12, 2022

How & why to build a QbD process to optimise the efficiency of your freeze drying projects

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
August 12, 2022

How freeze drying optimises the processing and viability of collagen bio-scaffolds

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.
August 12, 2022

Why Lyophilisation Training Courses Are A Lab Essential

Having well trained and informed personnel for your lyophilisation processing helps ensure the best results for your projects, productivity and pocket.
August 12, 2022

ADCs and BIOSIMILARS: The development towards a new generation of targeted therapies

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.
August 12, 2022

How To Ensure Your API Is Compatible With Its Formulation

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.
August 12, 2022

Superior results and efficiencies achieved in food freeze drying

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
August 12, 2022

How Biopharma Group is Solving The Freeze Drying Bottleneck For Diagnostic & Vaccine Production

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.
August 12, 2022

A 2020 Hindsight Look at How COVID-19 Has Affected the Freeze Drying Industry and What We Have Learned from It

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.
August 12, 2022

Why was utilising CRO services for freeze drying, so vital in response to Covid-19?

Earlier in 2021, we published our technical review on freeze drying in relation to the COVID-19 pandemic. As a follow-up, Dr. Mattia Cassanelli, Technical Manager of Biopharma Group’s consultancy division, has been interviewed to delve further into the benefits of freeze drying during this time, what was learned and what trends he expects to see for freeze drying in the future.