Bioprocessing White Papers

  1. Planning And Executing Cycle Development For The Vapor Hydrogen Peroxide Decontamination Of A Filling Line Isolator

    The cycle development approach described in this document is fairly universal and should not be dependant on individual isolator systems. The terminology used may be slightly different depending on the technology.

  2. Broaden Analysis Of Compound Factors For Predictive Solubility Solutions

    Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.

  3. Purification Of Mammalian Virus In A Single Step

    Viruses can infect mammalian cells and cause diseases such as influenza, hepatitis, yellow fever, smallpox, and AIDS. Since some biotherapeutic products are produced using mammalian cell lines or plasma, the risk of viral contamination in these products is a concern and guidelines have been enforced to alleviate this risk. Chromatographic separation of viral particles from process intermediates is a key part of ensuring viral safety in biotherapeutics (ICH Expert Working Group 1999, Moritz 2005). Additionally, purification of viral particles is used extensively in the study and characterization of these infectious agents.

  4. Streamlining Change Control In Today’s Complex Life Sciences Organizations

    Change control is collaborative, iterative and labor-intensive. For any specific change event, multiple users are required to follow a prescribed set of tasks and processes, which need to be carried out in a defined sequence and are subject to multiple stages of review and approval. It’s very easy to lose track of where you are in the process, what actions need to be completed next, who owns them, and when they are due. Yet the consequences of such lapses can be very costly. This paper examines why it is absolutely vital for organizations to take a comprehensive, closed-loop approach to automating change management, spanning all areas of the organization and extending throughout the product lifecycle.

  5. How Hollister Selected An Automated Solution For Tracking Product Registration And CAPA Management

    In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.

  6. For Regulatory Retention Compliance In Life Science Industries And Clinical Trial Research

    “Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP). Paper documents are also scanned into digital format (PDF) for storage and retention. This document explains the fallacy of thinking that system backup tapes suffice for electronic archive purposes. It then describes the characteristics of electronic archives and discusses the history and concepts supporting today’s practical experience with digital preservation for long term retention compliance in organizations subject to US FDA, EU EMEA, and other global authorities.

  7. 5 Reasons External Collaborations Fail In Drug Discovery

    In an effort to accelerate innovation, streamline the R&D process, satisfy healthcare expectations and improve the rate of return, pharmaceutical companies have come to embrace external collaborations and their outsourcing partners as an essential part of their discovery programs. This trend towards externalization is significant with roughly 90% of companies outsourcing some steps of drug discovery, and with half of all drugs now resulting from such partnerships. This white paper, discusses the different types of external collaborations research organizations engage in, the reasons that many of these partnerships fail to meet expectations, and an informatics solutions to overcome these issues.

  8. Maintaining Integrity Of The Supply Chain

    The cost associated with counterfeit drugs is staggering - both in human and commercial terms. In some cases, patients are deprived of treatment for diseases and conditions that range from mild to severe to life-threatening. In other cases, they are harmed by dangerous substances in the product, or become resistant to traditional therapeutic treatments or vaccines. In all cases, the public loses confidence in the companies that develop these drugs and in the very agencies that have been established to protect them.

  9. Modern Risk Management In Global Pharmaceutical Logistics

    Everything pharmaceutical manufacturers want to know about risk in supply chain logistics but are afraid to ask. What are the rising trends impacting security of product in transport? When and where does risk mitigation become mission critical? And — perhaps the most burdensome — how can I be sure?

  10. Critical Considerations For High Viscosity/High Volume Drug Delivery Devices

    By 2020, biologics are expected to make up more than half of the world’s top 100 selling drugs. To keep pace with these trends, device designers are tasked with overcoming various challenges associated with delivering these drugs. In particular are issues of high viscosity and/or high volume (HV/HV) associated with biologics. Since biologics cannot be taken orally, as the conditions within the stomach denature the molecules, biologics must therefore be delivered via an injection. While the challenges of HV/HV are not unique to biologics alone, per the abovementioned market trend, these drugs demand special attention from device developers.