The Emprove® program provides regulatory assistance to pharmaceutical manufacturers. For each filter and disposable component certified under the Emprove® program, three files are provided to support you at different stages of your operations: certification, risk assessment, and process optimization. Learn more in this video.
Compared with batch manufacturing, continuous manufacturing can provide shorter development time, higher product quality, lower capital costs, and ease of scaling up. The main focus is to establish a flexible and standard platform with control strategies for real-time monitoring, automatic startup/shutdown, and handling of dynamic conditions.
Quality Management System (QMS) is not a plug-and-play proposal. Ensure that your QMS investment contributes to the ultimate goal of meeting patient needs—while meeting regulatory compliance expectations—your QMS infrastructure needs to be strategically and consistently established, integrated, and engaged.
As the field of biologics pays more and more attention to identifying new target diseases and new structures for treating these diseases, innovative drug delivery devices have once again become the focus of attention.
Due to the complexity and temperature sensitivity of biological agents, we have seen an increase in non-traditional storage temperature requirements. Here, we explored why this happened and the related challenges.
API supply is to balance risks. Being prepared to ask and answer these 10 questions can provide clarity and confidence. Learn how to diversify your API supply chain.
The rapid rise of manufacturing methods such as viral vectors and mRNA vaccines coincides with the digital revolution. The holistic approach enables you to overcome challenges and seize opportunities.
Aseptic filling/finished product manufacturing is essential for high-value biological drug raw materials. Due to the large amount of time and resources invested upstream, errors that cause losses at such a late stage can be catastrophic.
Cytiva's predefined automation solution Figurate is now offered as a turnkey solution by combining our industry-leading ÄKTA process chromatography system with the reliability of the DeltaV DCS platform.
In this article, Dr. Kashif Ghaffar, a process validation pharmacist at Pfizer's Freiburg plant, discusses what needs to be considered during product development in preparation for commercial production.
Since the 1970s, flexible membrane isolation has been used for aseptic processing, but these systems are often a composite of stainless steel chambers and airflow modules with flexible membrane user interfaces.
In order to prevent costly changes to the manufacturing process, it is important to evaluate the foreign agent removal or inactivation efficiency of each operating unit during downstream process development.
Want to expand your liquid biological treatment scale and reduce transfer time? Learn how high-traffic, genderless, and large connectors make scale and efficiency simple and reliable.
This study explored the effect of implementing the 3M Emphaze AEX hybrid purifier during the clarification process on the removal of HCP that is problematic in downstream mAb purification.
High-density N-1 seed culture allows you to inoculate or replace large-scale N-1 bioreactors with a higher starting density for production (N) bioreactors, thereby improving your fed-batch process.
Review the considerations for making supply plans, the impact of early decisions and their impact on trial progress, and how decisions put patients and trials at risk.
The results show that the system can enable vaccine manufacturers to reduce the use of fetal bovine serum (FBS) while using diploid cells to achieve a potential increase in virus specific productivity.
Performing rapid research on monoclonal antibodies (mAbs) for rapid evaluation can help save time for busy analytical laboratories and reduce bottlenecks in mass spectrometer use.
The RoSS housing contains 3D foam to protect and secure the filled and frozen bags during transportation. In this study, we tested the effect of RoSS housing on the sterility of ISO cleanrooms.
Tom Evans, MS, CMMS, discussed the planning, resources, and capabilities required to effectively produce a customer's HPAPI therapeutics.
A case study showing how PBPK modeling, developability classification system, and biopharmaceutical drug distribution classification system can be used to facilitate the development of molecules.
Drug developers must successfully enter the market amid increasing regulatory and competitive pressures, while carefully managing technical and financial risks.
The actual implementation of a modern cell line development workflow using high-yield cell lines and automated systems has accelerated the development and commercialization of biologics.
Using key attributes to monitor the development process can shorten time, improve product quality, reduce costs, and implement the key knowledge gained from the analysis toolkit.
Explore the needs of more complex candidates through case studies that demonstrate the range of expression capabilities of mammalian and microbial-derived molecules.
As more and more products are transferred to disposable fermentation tanks, there is a greater need to improve oxygen delivery so that it approaches or exceeds the capacity of stainless steel vessels. In this webinar, we will share how we can further enhance HyPerforma SUF to meet the higher cooling requirements of high density, exponential growth, and high oxygen consumption cultures. Click here to register for this free webinar.
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