Biosimilar Manufacturing solution center

1. Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation 7/21/2021

   A robust human factors process has become critical to product optimization and market competitiveness for medical devices and drug delivery devices, but not all companies have the resources, funding, or time to conduct such user studies. This article from Genentech's head of human factors engineering examines the three major categories of evaluation that you should consider, the pros and cons of each, and how to select study participants.

2. Intensifying Upstream Processing - Implications For Media Management 7/19/2021

   Biopharmaceutical development and production require the investment of significant time and resources. Manufacturing procedures must be efficient, robust, and productive to minimize failure risk and ensure targets are met. In this eBook we discuss the benefits of implementing PI before exploring the potential implications on media management. We then outline the value in conceptual design to assist with the logistics of the media journey. Finally, we review the feasibility of implementing different PI scenarios in both existing and new facilities.

3. Enabling Broader Adoption Of Process Intensification In Biopharma 7/9/2021

   PI is becoming increasingly well-understood and its utility is continuously evolving to meet specific manufacturer needs, from product development to manufacturing, whether approached stepwise or end-to-end.

4. Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances 7/5/2021

   In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.

5. Managing Frozen Transport Logistics In The Biopharmaceutical Cold Chain 6/28/2021

   As biopharmaceutical manufacturing grows increasingly global, the production and transport networks required to keep operations running smoothly become more complex.  This paper provides a framework for making challenging decisions linked to cold chain management before outlining potential solutions that could solve many of the issues surrounding the frozen transfer of biopharmaceuticals.

6. Transforming Your Biopharma Automation Capabilities 6/24/2021

   The seamless functionality of single-use technology equipped with a scalable distributed control system (DCS) empowers you to capture the benefits of collecting and sharing data while simultaneously creating a connected enterprise that grows with the pace of your business.

7. Data Integrity In Supply Chain Risk Management During Zero Trust 6/21/2021

   Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.

8. Fully Single-Use Virus Filtration In Manufacturing – New Concepts And Strategies 6/8/2021

   To reduce time to market multipurpose facilities with fully single-use technologies are used which provides highest flexibility to bring the products fast into the market. Investment costs are much lower and in addition also safety aspects are considered in a much better way. These are just some advantages of fully single-use processes. This poster will focus on concepts for creating single-use virus filtrations steps in different manufacturing ways.

9. Protein A Resin Reduction Achieved With Process Transfer From Batch To BioSMB 6/7/2021

   A biopharmaceutical manufacturer was looking to reduce the operating costs of existing purification steps with high resin costs. In this case study they review transferring an existing batch chromatography process into a multi column format and then scaling up that process to an continuous perfusion run. The result was a dramatic reduction in protein A resin requirements.

10. Extraction of mRNA From IVT Mixtures With CIMmultus® Oligo dT Column 6/7/2021

    The increasing demand for messenger RNA (mRNA) as a therapeutic product requires larger production scales and more efficient extraction techniques. Here the fast and efficient way to purify polyadenylated mRNA using affinity chromatography on the CIMmultus® Oligo dT column is presented.