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WHITE PAPERS AND CASE STUDIES

• Impact Of Glycosylation On The Effector Functions Of Monoclonal Antibodies

  In an example using rituximab and its biosimilars, explore the significance of minor differences of glycosylation in antibodies and its impact on their properties and functionality.

• The EMR Interoperability Dream Vs. Clinical Research Reality

  Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.

• Streamlining Study Start-Up For Accelerated Drug Development

  What is the secret to safely expediting study start-ups? Explore our case study to find out how open dialogue, aligned expectations, and direct communication between Altasciences’ team leads and sponsor contributed to a clinical trial start-up of only 3.5 weeks.

• Exploring Perfusion Technology For Virus Manufacturing Process Intensification

  Perfusion cell culture technology supports high cell densities and product yields for viral vaccine manufacturing, offering a reliable way to produce high-quality cells at a commercial scale.

• Leveraging High-Pressure Sterile Filtration For Highly Viscous Solutions

  This research demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.

• Facility-Fit-Driven Process Development For A Monoclonal Antibody

  See how proactively designing around plant constraints, using high-capacity resins, and leveraging parallel workstreams resulted in a 50% reduction in processing hours and 25% lower costs.

• Tailored ISO 5 RABs Unit To Protect AST's Patented Filling Machine

  Uncover how AST's satisfaction with Germfree's solution led to the acquisition of two additional units, showcasing the project's success and Germfree's expertise in tailored cleanroom solutions.

• Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap

  As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

• Expand Bandwidth With A Trusted Regulatory Writing Partner

  Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

• Top 10 Global Pharma Company Dramatically Improves Site Payments In Drive To Become Sponsor Of Choice

  See how a pharma company reduced investigator payment cycle time by 55% while decreasing their own administrative burden by 90% in this metrics-rich case study.

• How Community Oncologists View CAR T-Cell Therapy Possibilities And Challenges

  Learn how a partner with innovative solutions aimed at overcoming the barriers that limit the real-world impact of CAR T-cell therapy can make these advanced therapies more accessible and affordable.

• UV Treatment Upgrades In Wales

  In order to improve the treatment performance (because of the continued cost to maintain compliance), and ensure that it would eventually have the treatment capacity to meet future population growth equivalent of up to 225,000, Swansea WwTW was in need of an equipment upgrade.