Monoclonal Antibodies
Process Development and Application Expertise

Safety

Improvement in patient safety comes in all forms — from aggregate control to strategies that minimize risk from extractables and leachables. Proactive evaluation and adoption of strategies to reduce or eliminate exposure benefits both drug manufacturers and consumers.


1. Evaluating Technical Advances in the Quality Control of Biologics

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While QC guidance documents are revised periodically by regulatory agencies and international organizations, revisions typically lag behind scientific advances and technical innovations. Don’t wait until new regulations are in place to explore new approaches to enhance processes and product quality.

Cell line characterization, bulk harvest and lot release testing offered by our BioReliance® Services are essential for meeting regulatory requirements and represent state-of-the-art innovation and new approaches for genetic stability and clonality determinations, cell line identity testing, Spiroplasma testing, and evaluation of in vitro assays for extraneous agent detection and replacement of in vivo assays.


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Articles:

  • Roundup on cell-line authentication
    GEN, November 2013
    Even though techniques and culture conditions have improved, the problem of misidentified cell lines or cellular cross-contamination remains at a very high level. GEN recently spoke to a number of cell-line authentication experts to find out just how large a problem this is and to determine what companies are doing to address this issue.

2. Detecting and Removing Aggregates

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The presence of aggregates can pose a great risk to patients and create process challenges for biomanufacturers, including reduced yield. The mechanisms of aggregate production are manifold and at times unclear, which drives the need for a comprehensive management strategy.

Aggregate management can be achieved by a number of approaches including:

  • Molecule and cell line manipulation
  • Informed selection of process consumables
  • Control of process parameters
  • Deployment of excipients

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3. Mitigating Viral Contamination Risk

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Adventitious viruses can enter the production processes via multiple different routes: cells, raw materials, personnel, or the environment. In addition, mammalian cell lines contain endogenous virus-like particles that need to be removed in downstream purification.

A holistic approach to viral safety relies on a multilayered strategy involving:

  • Preventing viruses from entering the upstream process:
  • Detecting viral contaminants
  • Removing or inactivating virus in downstream purification

Learn more


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Videos:

  • Viral Safety Assurance
    We rely on the principles of the biosafety triangle "prevent, detect, remove" to evaluate options for mitigating the risk of viral contamination in the upstream process and for maximizing viral clearance in downstream purification. Watch this video series to learn more.

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4. Worried About Extractables and Leachables?

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Use of polymeric single-use containers and assemblies can inadvertently add substances that can end up in the final product, potentially leading to:

  • Health risks to the patient
  • Alteration of the stability and potency of the drug product formulation
  • Interference with assays used to measure drug product properties

You need a risk-based extractables and leachables evaluation for drug manufacturing processes and strategies for addressing this challenge.


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Application Note:

  • PureFlex™ and PureFlex™ Plus films: extractables evaluation
    The purpose of this report is to provide extractable data relevant to disposable process containers assembled with our PureFlex™ or PureFlex™ Plus films and to demonstrate the comparability of the extractables profile from the two films. This report is a compilation of three studies performed using PureFlex™ and PureFlex™ Plus film.