Business Process Management

WHITE PAPERS AND CASE STUDIES

• Duni Wipes Out Manual Work With MediusFlow

  Duni manufactures and distributes innovative tabletop concepts, creative packaging and take-away solutions for professionals and consumers in more than 40 countries across the globe. The company processes approximately 100,000 invoices per year through MediusFlow’s AP automation solution connected to SAP.

• Considerations for improving outcome in biopharmaceutical process development

  In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.

• Avoid Costly Mistakes In Gene Therapy Process Development

  Success in the evolving and highly competitive gene therapy space requires navigating many uncertainties related to process development and manufacturing of adeno-associated virus (AAV) and lentivirus vectors. These tips will guide development and manufacturing teams operating on compressed timelines.  

• Madrona Specialty Foods Improves Efficiency With ERP Software System

  Madrona Specialty Foods was relying on multiple, independent platforms to run its business prior to going live on JustFood in 2017.

• The Role Of CDMOs In Cell And Gene Therapy Process Development

  This article highlights areas where CDMOs can help companies get started in CGT manufacturing. We also discuss when to engage with CDMOs to maximize commercial and clinical success.

• Pharmaceutical Manufacturer Guarantees Traceability Withs Serialization Solution

  At Lilly Deutschland GmbH, particular emphasis is placed on safety and quality, as physicians and patients need to be able to rely on the effectiveness and safety of medicines. Due to the increasing number of counterfeit products in the pharmaceuticals market, Eli Lilly was looking for a precise and reliable serialisation solution that would enable the company to continue guaranteeing the traceability and thereby the safety of its pharmaceutical products.

• A Comprehensive Guide To Ad Hoc Reporting For SaaS

  “Why should I give my users ad hoc reporting? They don’t want to create reports. Half of them barely use Excel.” We get variations on this question from software vendors all the time.

• Lyophilization Of Highly Potent Drugs: Facility and Equipment Design Elements

  Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.

• Meat Supply Chain: A 'How To’ Guide For BRCGS Audits

  BRC Global Standard for Food Safety Issue 8 emphasizes an end-to-end approach to food safety. Here are some steps to understand and comply with a BRC audit of your current practices and vulnerabilities.

• Reducing The Risk During Cell And Gene Therapy Development And Manufacturing

  While these new modalities are generating significant excitement among patients and caregivers, cell and gene therapy manufacturers are experiencing growing pains. The rapid growth and continued momentum of the industry has led to the issuance of new guidance. In this article we share insights for navigating within a novel and complex regulatory environment, mitigating risks posed by raw materials and implementing proper risk assessments during manufacturing.

• Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring

  Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

• How Can Outsourcing Buffer Preparation Help Meet The Urgent Need For A SARS-CoV-2 Vaccine?

  As numerous therapeutic drug and vaccine candidates make their way through human clinical trials, companies are already planning for how to manufacture any successful molecule on a global scale. In this planning, the preparation of process liquids and buffers should be considered.