Outsourced Pharma App Notes & Case Studies

31. Effects Of Feeding Strategy On CHO Cell Performance In Fed-Batch Cultures Using HyClone™ ActiPro™ Medium And Cell Boost™ 7a And 7b Supplements 2/21/2020

    ActiPro cell culture production medium is intended to be used in combination with Cell Boost 7a and 7b supplements to enhance recombinant protein production in fed-batch or perfusion processes. This work demonstrates the development of a fed-batch process for a CHO cell line producing a monoclonal antibody (mAb). The results emphasize the importance of an appropriate feeding strategy to achieve optimal cell growth and productivity.

32. Reducing Cost Within Advanced Therapy Clinical Trials 4/10/2019

    The challenge for advanced therapy companies is that they need to develop a supply chain that delivers their therapy, at scale, without adding significantly to the cost of goods sold (COGS). In this case study, you'll learn how a company saw 55% cost savings across its distribution system and increased visibility of its supply chain through utilizing a Total Transportation Management (TTM) system.

33. Industry 4.0 Connects Machines And Data 10/26/2018

    By applying remote monitoring, advanced modeling, and optimization of manufacturing processes, Industry 4.0 offers process reliability and product quality through connecting machines and data.

34. Development Of Qualified Cold Chain Solution For Vaccine Transport To Uganda 4/8/2019

    Maintaining the cold chain is a challenge when handling biologics such as vaccines, particularly when the clinic is in a remote location. Learn more about how Fisher Bioservices developed a qualified cold chain solution to transport Ebola vaccines to Uganda.

35. Making The Business Case For Vaccine Manufacturing 10/10/2018

    Vaccines are absolutely crucial for maintaining global health, but are a challenge to develop and manufacture. How can businesses ensure profitability while providing low prices for developing countries?

36. Quality By Design: A Holistic Approach To Drug Development 8/20/2018

    While QbD evolves from good practice to agency requirement, how can sponsors ensure that rigorous, scientific risk-based approaches are used to bring better and safer therapies to market faster?

37. Amgen’s Digital Transformation: Link Suppliers' Raw Material Data To Patients 10/19/2018

    Using its Supplier Relationship Excellence program, Amgen opened the lines of communication with suppliers and created a feedback loop where data can be shared to optimize operational performance. 

38. Risk Mitigation For Material Transport: The Impact Of Re-Using Shippers 3/7/2019

    Ensuring your material is stored under appropriate conditions is only half the battle in preserving its integrity. Equally as critical is the precarious process of transporting your material to its destination, safely and in the same condition it was sent in. Maintaining the chain of custody is of utmost importance, and a large component of this is based on the vessel selected for transportation. In this article, we’ll share some key items to consider when selecting shippers to transport your high value material.

39. Pulse Check: How To Assess Your In-House Biomanufacturing Capabilities 6/18/2018

    By checking the pulse of your organization, you can identify gaps and develop a plan for how to address them, so you can make the right decisions at the right time.

40. Cell Culture Titer & Protein Quality 2/21/2020

    When evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. So how can this process improvement be performed reliably? It makes sense to use a Design of Experiment (DoE) and empirical approach. Here is an example of how to do it.