Clients often come to us with protein conjugation process needs that can require development of new and innovative methods to assure process validation for conformance manufacturing. Our staff utilizes state-of-the art technologies and instrumentation for a wide range of protein drug manufacturing challenges. These scientists provide the expertise and experience needed to develop accurate and highly reliable assay methods designed specifically to assure successful conformance manufacturing of their protein-hapten or protein-drug conjugate. This white paper illustrates just one example of…
Manufacturing
The Standardization of Single-use Components for Bioprocessing
As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. While the standardization discussion encompasses many topics (including how products are tested, assembled, etc.), components are a critical area for improvement. With so many ways to apply single-use and hybrid bioprocessing systems, organizations must take action to standardize equipment in order to streamline operations and help reach the full potential of the technology. This paper discusses standardization in…
Solving Viscosity in Automated Particle Imaging
Micro-Flow Imagingâ„¢ (MFI) easily detects particle size and morphology on a wide range of particle contaminants. And when you add the Bot 1 Autosampler to your MFI 5000 Series system, you’ve got the automated go-to method of choice for particle analysis today. Together, this combination lets you quickly screen for any changes in levels of particle contaminants like protein aggregates and silicone oil in your biopharmaceutical formulation. Highly concentrated protein solutions can be a little trickier to analyze with other…
Your Reliable Contract Manufacturing Solution Partner in China
This whitepaper focuses on Boehringer Ingelheim’s development and manufacturing facility in China. As one of the world’s leading organizations in the area of biopharmaceutical contract manufacturing, Boehringer Ingelheim is the first multi-national pharmaceutical company that brings over 30 years of experience in biopharmaceutical contract manufacturing to China, to better serve patients and the biopharmaceutical industry – both in China and in the world. As a pioneer in biopharmaceuticals with more than 35 years of experience the company has brought more…
ThawSTARâ„¢ Automated Cell-Thawing System: Breakthrough Adaptive Sensing Technology for Reproducible, Standardized Cell Thawing
Advances in cryopreservation techniques have been crucial for the substantial progress achieved in many fields, including cell biology research, drug discovery, bio-banking, and assisted reproduction. While cryopreservation techniques have markedly improved, downstream cell thawing techniques have thus far been neglected, even though proper thawing of cryopreserved materials is essential for optimal cell viability. The success of high-promise fields such as cellular therapy and regenerative medicine require reproducible and standardized handling of the therapeutic cells, which includes thawing both during manufacturing…
Secondary Packaging: Creating Value with Product Lifecycle Management
with Daniela Guttmann and Susanne Hall Increasing regulatory requirements combined with the market pressure to develop patient-friendly drug delivery systems make product lifecycle management (PLM) a decisive field for today’s pharmaceutical and biotechnology companies. Their strategic service providers also are affected by those conditions. For example, as an internationally operating contract development and manufacturing organization (CDMO), Vetter reports an increasing number of life-cycle management projects with its customers in the past years. Learn more in this white paper from Vetter.…
The Path to Genderless Connectors: How Genderless Connectors Lead to More Flexibility, Faster Changeovers and Reduced Costs
Genderless sterile connectors — with their ability to interconnect with each other without male/female limitations — can enhance the flexibility of single-use systems in a wide range of bioprocessing applications. Genderless connectors reduce system complexity, which in turn lowers requirements for inventory management, simplifies operator training and reduces misconnections in the manufacturing suite. In fact, it’s possible this new connector design will drive industry change similar to the transition from stainless, reusable systems to single-use. How can something as small…
Single-Use-Bioprocesses – Hype or Future Technology?
Single-use technology have become indispensable in biopharmaceutical manufacturing. Rentschler is one of the first contract manufacturers worldwide to establish a complete single-use facility for the upstream and downstream processes.
Security of Supply for Chromatography Media
This white paper discusses GE Healthcare Life Sciences extensive preventive actions taken to help secure a continuous supply of chromatography media for biopharmaceutical manufacturers.
Setting the Standard for Plasmid DNA Production
Boehringer Ingelheim stands out due to global contract manufacturing excellence in plasmid DNA production. It is one of the world’s leading companies for contract development and manufacturing of biopharmaceuticals