Industry Insights

  1. Streamlining Recombinant Protein Production

    Bringing a recombinant protein to market requires a substantial investment of time and resources, and the process is generally complex and subject to technical pitfalls.

  2. A Cost-Effective Alternative To Size Exclusion Chromatography

    The aim with this white paper is to discuss the advantages of using Capto Core 700 in virus purification compared to size exclusion chromatography (SEC), a technique commonly used in several vaccine processes.

  3. Accelerate Process Understanding, Innovation, And Time To Market In Biotech

    Multivariate analysis is the investigation of many variables, simultaneously, in order to understand the relationships that exist between them.

  4. Following FDA Guidance: Continuous Improvement In An Outsourced Environment

    In May 2013 the U.S. Food and Drug Administration (FDA) released its draft guidance, “Contract Manufacturing Arrangement for Drugs: Quality Agreements,” with recommendations representing its “current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.”

  5. Improve Operations, Collaboration, And Time-To-Market: The Digital Lab

    Many leading life sciences companies have introduced cost-reduction initiatives to automate routine, non-value-added tasks related to data capture, cataloguing and documentation activities as products move from discovery through development to late-stage quality control, manufacturing and commercial operations.

  6. How To Avoid 5 LIMS Nightmares

    Traditional Laboratory Information Management System (LIMS) implementations are notorious for keeping people awake at night. Industry analysts like Strategic Directions and ARC Advisory Group have estimated the failure rate of commercial LIMS solutions to be as high as 60 percent with many of them failing to deliver original customer requirements after lengthy and expensive deployments.

  7. Exploring Collaboration With Third Parties And The Impact On Document Management

    The trend towards virtual pharma is accelerating and as it does, the life sciences industry is undergoing a profound structural change. The areas of development and commercialization which were once conducted within the confines of one company have now become a collaboration within an ecosystem of entities, both public and private.

  8. Pharma Seeks Long Tail Of Flexible Manufacturing

    It is no secret that pharma lags behind other industries when it comes to innovation in manufacturing, but the industry does have its eye toward new models of manufacturing.

  9. Missed Opportunities For Adventitious Agents Testing

    Current adventitious agent test methods feature numerous limitations. Assays based on polymerase chain reaction (PCR) offer the potential to lift these limitations and offer better overall detection of adventitious agents. This is an area that biologics manufacturers are actively exploring, and current research indicates that PCR-based testing is not only scientifically valid but also acceptable to regulators.

  10. Don't Be A Daredevil When Retrofitting Your Facility

    With mergers/acquisitions and cost-cutting initiatives, facilities are being shut down and product lines consolidated into existing facilities—risking sub-optimal layout and design.