This handbook gives a general introduction to the principles and applications of cross flow filtration using systems and filters from GE.
This poster focuses on how the resin selection and architecture of a bioprocess film can be optimized to maintain critical performance attributes, such as container integrity and gas barrier properties, under the significant forces during bulk liquid transportation and WAVE Bioreactor™ system applications.
Considerations when choosing a contract manufacturer for drug substance development or finished dosage forms.
This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.
White paper on the risks related to bioburden downstream processing and the solutions available to mitigate these risks. Topics covered include improvements in raw material quality, equipment design, chromatography resin properties, and ways of working.
Setting up a perfusion process is complex, and getting the best out of it requires an awareness of the do’s and don'ts of the approach. Design of experiment (DoE) and quality by design (QbD) approaches help the development of a production process that is both cost-effective and high quality.
Design of Experiments (DoE) mathematical models can help create the perfect environment for batch and fed batch cultures. Understanding the different criteria and their interactions with each other can be a key differentiator in the race to get your drug to market.
Fermentation and cell culture can be carried out in batch or continuous processes. Reminding ourselves of the basics is vital for the development of more cost-effective and efficient biotech production processes. This article reviews those basics to understand the methods best suited for your development.
The understanding of lab-scale processing, from cell and media type to bioreactor size and scale-up, is a vital part of its development. This article reviews the key steps and considerations to aid in developing the process while keeping costs down.
In June 2017, Canadian company PlantForm announced it was beginning construction for a pilot biologics and biosimilar manufacturing facility in Brazil. Given Brazil’s ongoing efforts to establish a local biotechnology industry, I reached out to learn more about PlantForm’s progress in navigating the regulatory landscape to bring its biosimilars closer to market.
As the first of this two-part article revealed, the biosimilar market has undergone several revolutions since the release of the Thai FDA’s biosimilar guidelines in 2013. During our tour of Siam’s facilities, the company’s managing director, Songpon Deechongkit, Ph.D., shared the company’s history, overall biosimilar strategy, and some of the pros and cons of being the first and only biosimilar company in Thailand.
To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.
Samsung Bioepis celebrated its fifth anniversary in February 2017. I met with Paul Song, VP at Samsung Bioepis, to learn more about the company's motto, "Process innovation," which is credited for the company's swift rise to leadership in the European market.
The 2017 Amgen "Trends in Biosimilars" report called attention to a few trends that align with what I’ve been observing within the industry that manufacturers, payers, and prescribers should expect for the year (and years) ahead.
Over the past year, the biosimilar industry has developed two mantras: “education, education, education,” and “strategy, strategy, strategy.” But after my conversation with HoUng Kim, the head of the strategy and operations division for Celltrion Healthcare, I’d like to add another mantra to this list: “data, data, data.”
Biosimilars are considered to be low-cost substitutions for pricy, large-molecule biologics. However, biosimilars must meet the same quality, safety, and efficacy as their reference biologic. Manufacturing biosimilars requires a more complicated procedure than that of manufacturing small molecule generics. Companies manufacturing biosimilars are focused on creating a chemical structure that is as close as possible to that of the reference product. Failure rates and operational costs pose a challenge for those companies involved in manufacturing biosimilars compared to those manufacturing small molecule generics.
Small molecule generics are created using the same active pharmaceutical ingredient (API) and, therefore, are chemically identical to that of the originator medicine. The manufacturing process for small molecules comprises only one-fifth of the total in-process tests required to meet Good Manufacturing Practice compared to that of biologic medicines (50 vs. 250 in-process tests). In fact, the manufacturing process for a large molecule is so complex, it cannot be duplicated by two different manufacturers, as the cells used in biologic medicines are unique to the company manufacturing each biologic.
Manufacturing a biologic consists of genetically modifying a cell, which becomes the basis for a cell line used for the production of the necessary protein for the biologic medicine. The protein is then separated from the cells and purified. Biosimilars are created from small alterations to the manufacturing process which creates a molecule that is not identical but closely resembles the reference product. While the differences in the biosimilar molecule might be slight, these changes in the manufacturing process of a biosimilar can affect the efficacy and safety of a biosimilar compared to the reference biologic. Over the past decade, the manufacturing process for proteins has become more standardized and the required technology has become increasingly accessible, leading to reductions in biosimilars production costs. As a result, a greater number of companies have begun manufacturing biosimilars, while reference brand manufacturers are setting their sights on bolstering pipelines and manufacturing biobetters to maintain market share for their soon-to-be-off-patent reference products.
