FEATURED ARTICLES

• One Size Does Not Fit All: Utilizing Multiple Technology Providers In Gene Therapy Manufacturing

  With a diverse landscape of potential partners, it is important to know what qualities to look for in a technology provider and how to traverse the challenges inherent in managing multiple relationships.

• Bioprocessing And Scaleup Of HEK293 Cells For AAV Production

  MilliporeSigma has developed the VirusExpress®️ AAV Production Platform as a scalable upstream AAV production solution for viral gene therapies.

• Viral Clearance Considerations For Adeno-Associated Virus (AAV) Viral Vectors

  There is no one-size-fits-all model for AAV gene therapy products when it comes to viral clearance studies. Here we address some of the questions with respect to viral clearance studies for AAV vectors.

• Lay The Proper Foundation For Upstream Success

  When selecting a partner for development of upstream processes you need speed, quality and regulatory compliance – all appropriately balanced.

• A Platform Standard For Viral Vector Manufacturing And Commercialization

  Learn more about platform technologies that are being developed and implemented to support large-scale production of viral vectors.

• Explore Performances Of The EX-CELL® CD Insect Cell Medium

  Because viral safety is essential in the manufacture of biopharmaceuticals, we developed a proven Sf9-rhabdovirus-negative insect cell line that improves the safety profile of our customers’ bioprocesses.

• Enabling Vaccine Production: Solving Challenges Together

  This e-book contains a series of case studies highlighting our recent collaborations with organizations and thought leaders on the front lines of the battle against challenging pathogens and infectious diseases. 

• The Evolution Of AI: Benefits To Biopharma

  Considering the complexity of bioprocessing and the industry’s inherent “data siloes,” this paper focuses on how companies can use the power of smart data to leverage AI and drive additional insights.

• Perspectives On Trends In Outsourcing The Development And Manufacturing Of Biologics

  Read more on trends related to outsourcing and share what attributes of an outsourcing partner that are sought by developers and manufacturers of biopharmaceuticals.

• A Molecule’s Journey: Break Down Roadblocks To Commercial Manufacturing Success

  Our experts share key considerations for biopharmaceutical companies as they advance to commercial manufacturing and navigate complexities associated with business planning, process scale-up, optimization and validation, technology considerations and regulatory compliance.

• AAV Process Development Guidance Based On Cost Modeling

  Cost modeling can be a powerful tool to assist with prioritizing areas of focus for process improvement during process development and especially useful for processes producing viral vectors for gene therapies.

• Development Of A Novel Sf9 Rhabdovirus-Negative Cell Line (Sf-RVN®) And Companion Chemically Defined Medium

  This whitepaper describes the development of a novel Sf-RVN® cell line, with companion chemically defined medium, the EXCELL® CD Insect Cell Medium which can be combined and offer a Sf-Rhabdovirus free alternative for the BICS production of biologics.

• A Multifaceted Strategy For Viral Safety In AAV Processes

  Assurance of viral clearance can be difficult, however, during production of vectors such as adeno-associated viruses (AAV) used for the purpose of gene delivery. The need to define and deploy an appropriate and robust viral clearance strategy can be particularly challenging without an overarching strategy in place.

• CAR-T Therapy Manufacturing With The ekko™ Acoustic Cell Processing System

  Explore how the ekko™ Acoustic Cell Processing System enables user-friendly automation of the harvest, wash, and concentration steps required to prepare T cells for preservation.

• Acoustic Cell Processing With ekko™ System

  The ekko™ System overcomes the challenges of concentrate and wash steps throughout the cell therapy process by employing acoustic technology to gently process cells.

• Regulatory Guidance On GMP Software

  Explore the regulatory requirements for software in a biopharmaceutical GxP environment and why software is invaluable for creating an audit trail, reporting, and automating regulatory-related tasks.

• The Impact Of Facility Design On The Safety Of Viral Vectors

  It is critical to vet not just the expertise available at a CDMO, but also the effectiveness of their facility design to reduce risk and meet scale-up needs.

• CDMO Solutions Help Today’s Biopharma Executives Mitigate Risk When Time Is Of The Essence

  Insights and advice from a team of experts about how to leverage strategic approaches to process development and risk management while meeting strict timeline and regulatory requirements.

• Multivariate Inter-Stage Batch Profile Monitoring And Future State Estimation For Efficient Manufacturing Operations

  How much quicker and easier would it be if we could know the process’s health by looking at a single metric rather than checking hundreds of parameters?

• Perspectives Of Value-Driven, Integrated Solutions In Gene Therapy

  By unlocking the value of an integrated solutions provider, you can leverage a comprehensive suite of advanced technologies and expertise that will facilitate your path to market and benefit you for the lifetime of your product.