Minimizing Sterile Filtration Risk Through Quality By Design

November 13, 2018

Controlling bioburden throughout biomanufacturing processes is critical to assuring drug products are safe for human use. To ensure products are free from microbial contamination, multiple filtration steps are implemented across the biomanufacturing process.  The final sterilizing filtration prior to filling is especially critical, and filtration performance should be confirmed according to industry standards and test criteria.

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MedTech Association

MedTech connects New York State’s Bio/Med industry through collaboration, education and advocacy. We are an active association of pharmaceutical, biotech and medical technology companies, their suppliers and service providers, and research institutions.

OTHER WHITEPAPERS
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Use of PS-DVB Columns and Matched Buffers in the Purification and Scale-Up of mRNA Drug Candidates

whitePaper | August 24, 2022

The validity of mRNA as an approved pharmaceutical is now largely accepted, with the historic launch and administration of billions of doses of mRNA Covid vaccines (1).

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Accelerating Global Access to Gene Therapies: Case Studies from Lowand Middle-Income Countries

whitePaper | October 18, 2022

This document is published by the World Economic Forum as a contribution to a project, insight area or interaction. The findings, interpretations and conclusions expressed herein are a result

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GMP Grade PMSF and Protease Inhibitors

whitePaper | February 23, 2023

Phenylmethylsulfonyl fluoride, better known as PMSF, is a small molecule serine protease inhibitor used to prevent unwanted proteolysis.

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Imaweld® heat sealable & weldable tube bioprocess media

whitePaper | February 3, 2023

Imaweld® is thermoplastic elastomer tubing particularly designed to transfer critical fluid in pharmaceutical and biopharmaceutical applications.

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Enabling the Future of Cell & Gene Therapies through Non Proprietary Patient-Owned Data Collection

whitePaper | March 16, 2021

Cell and gene therapies have emerged as a new treatment paradigm, and with them has come the potential to alter the course of many rare diseases. In many cases, there is an opportunity to correct the underlying dysfunction with a one-time administration of a therapy and provide either a functional cure or a substantial improvement in health outcomes. In other cases, long term symptom relief will be the primary therapeutic objective. Some of these indications may require more than one dose to achieve continued symptom relief and scientists and companies are working on technologies that will enable the use of a repeat dose.

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Your Ultimate Guide to CMC Testing Support for Gene and Cell Therapy

whitePaper | December 6, 2022

The development of Advanced Therapy Medicinal Products such as gene and cell therapy products, has made significant progress in the treatment of many diseases, including cancer, genetic, and autoimmune disorders.

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Spotlight

MedTech Association

MedTech connects New York State’s Bio/Med industry through collaboration, education and advocacy. We are an active association of pharmaceutical, biotech and medical technology companies, their suppliers and service providers, and research institutions.

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