Solution for challenging antibodies – Planova™ S20N
Designed as a next generation cellulose-based virus removal filter, Planova™ S20N has demonstrated robust filtration performance for challenging molecules regardless of process design.
Processing equipment
Manufacturing Friendly Aggregate Clearance in Downstream Processing of Bispecific and Traditional Antibodies Using a Novel POROS
Bispecific antibodies (BisAbs), which can bind to two distinct antigens, are prone to high levels of aggregate (10-30%), challenging traditional platform downstream processes and impacting product yields. Mixed-mode chromatography (MMC) presents a...
Efficient Freezing & Storage of Biopharmaceuticals
Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be confusing.
Plan for success with process liquid and buffer preparation
Setting the groundwork for successful scale-up is essential for getting a therapeutic to market quickly and efficiently, but navigating the unknowns associated with this process can be challenging. Beyond procurement challenges, raw materials need to...
HEALTH IS A JOINT PROJECT READY FOR NEXT-GENERATION CDMO
Indena offers custom development by leveraging the expertise of a specialized team devoted to designing and developing processes and analytical methods.
High-Quality Clinical Studies Require a Modern Medical Monitor
Medical Monitors are overwhelmed by the sheer volume and variety of data they need to sort through to find, investigate, and react to safety signals.
Strategies to Achieve Successful Approval & Launch
There are several key considerations to how companies should approach commercial-scale manufacturing that may aid the success of their biologic’s launch into European markets. In some cases, there is a need to identify a partner to support the product’s...
Seed Train Intensification Using High Cell Density Cryopreservation and Specially-designed Expansion Medium
Upstream processes can be intensified using a number of strategies which can deliver significant improvements in speed, flexibility and reliability. In this whitepaper, we explore two of these approaches – High cell density cryopreservation (HCDC) and...
Process Optimization and Scalability Evaluation of Pellicon® Capsules for Single-Pass Tangential Flow Filtration of mAb-Based Biomolecules
Single-pass tangential flow filtration (SPTFF) is a method of ultrafiltration for the purposes of either volume reduction or protein concentration. This versatile method has been successfully implemented between unit operations throughout the downstream...
Shifting the Biomanufacturing Paradigm
Adoption of next generation processing and technologies can enable improvements in productivity by streamlining workflows, reducing the manufacturing plant footprint and increasing flexibility. And while the benefits of next generation processes are...
Driving value towards the evolution of upstream processes - Case Study: Intensified Seed Train
Perfusion involves the constant feeding of fresh media and removal of spent media and product while retaining high numbers of viable cells within the bioreactor vessel. With the increased pressure to drive down manufacturing costs and to improve facility...
How to get reproducible DNA amplification
DNA concentration, mastermix preparation, temperature management: Doing PCR like a pro can be more complex than it seems.The Eppendorf infographic helps you to stay on top of your PCR.Our tips and...
Customized Biosimilarity Analytical Testing from Catalent
Assessment of biosimilar molecules requires an orthogonal analytical approach. Any one particular analytical technique is not able to fully define the physical and biological characteristics of...