Whitepapers

When developing a new drug product, quality, safety and timing are critical. A Contract Development and Manufacturing Organization (CDMO) can be a valuable partner to help mitigate risks, avoid missteps and control costs in the process. But the success of the partnership revolves around a key step: the technology transfer.

In this work we discuss an automatable sample preparation protocol for peptide mapping used in QC, bioprocess, analytical development, and research environments to deliver comprehensive information about the primary structure of biotherapeutic proteins.

As more biologics move through research and development, the demand for specialized aseptic fill/finish services has steadily climbed. Aseptic processing with the highest degree of sterility assurance, filling accuracy and quality is critical for high-value, small-batch therapies. Anything less impacts regulatory compliance, project timelines and—most importantly—patient safety. This white paper explores the specialized equipment, expertise, and services needed for efficient biologics fill/finish manufacturing.

In this work we discuss an automated high-throughput sample preparation method and fast LC-MS peptide mapping for Critical Quality Attribute (CQA) peptide measurement that was developed for low volume and low concentration microbioreactor samples.

In this work we discuss how to achieve complete and clean trypsin digestion with an enzyme that provides a balance of missed cleavage, non-specific cleavage, and trypsin autolysis.

This SGS Health Science whitepaper uncovers the changing regulatory environment, and the challenges posed by the detection of nitrosamine impurities in drug products.

Bioprocessing for protein production is a time-consuming process, typically lasting about two weeks. It is increasingly desirable to routinely monitor critical process and product attributes such as changes in nutrient profiles and high level glycoform information for the drug substance. Read our latest application note to learn how the newly launched bioprocess walk-up solutions enable bioprocess engineers to collect attributes easily and rapidly for process related monitoring and optimization using the Andrew+ Pipetting Robot, Waters OneLab Software and the BioAccord LC-MS System.

Waters bioprocess walk-up solutions unlock access to high quality process and product data with just a few clicks, even for users with little knowledge of mass spectrometry. Providing streamlined integration of automated sample preparation and LC-MS analytics simplifies, accelerates and advances your bioprocess development.

This report explores rapid vaccine development during the pandemic and how process changes with the help of advanced manufacturing could aid the development of medicines.

This whitepaper explores the criteria for defining true quality in a CDMO partnership, including multiple product, process, and relationship variables

With this white paper, explore how advanced lab informatics and digital tools can help unlock the potential of scientific data for business growth.

This application note demonstrates how Aura® systems can quickly and accurately characterize therapeutics for particles and product purity and stability.

Reaching sustainability and efficiency goals simultaneously is possible in RMID, a regulatory-enforced part of (bio)pharmaceutical drug manufacturing.

This technical overview discusses best handling practices for IVT mRNA and analysis with the Fragment Analyzer systems, including sample handling and quantification tips.

A two-step mAb purification process was developed, tested, and intensified. Increased process productivity, while exhibiting robust impurity clearance and high yield, was achieved.

The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the industry. Technology to support their rapid growth must simplify and streamline processes during drug development.

To support the growing need for nitrosamine testing, SGS has expanded its volume for nitrosamine testing beyond its current service offering in Mississauga, Canada. SGS has added capacity and instrumentation to offer nitrosamine testing, including drug substance-related impurities (NDSRIs) at its West Chester, PA and Markham, Canada laboratories to allow for expanded capacity for nitrosamine testing, while staying ahead of the curve as regulations continue to evolve.

SGS has developed a network of centers of excellence for Nitrosamine testing across all regions to better serve our clients. Our experts specialize in method development solutions to identify and quantify all nitrosamine contaminants, including the challenging nitrosamine drug substance related impurities (NDSRIs).

This article provides an assessment of nitrosamine contamination specifically in biologics and contrasts the potential risks between these product types.

Discovery why evaluating a CMO’s internal processes, facilities, capacity, capabilities, and communication is key to successful ophthalmic scale up and manufacturing.

There has been a Growing concern among regulators driving a need for awareness for manufacturers to understand the risk associated with nitrosamines in pharmaceutical and biopharmaceutical products. In this session of Changing the Conversation with SGS Live, we tackled a variety of aspects of this important issue from the risk associated with nitrosamine contamination to discovery and mitigation of nitrosamine impurities. Our experts shared the current testing requirements, along with how SGS is helping drug manufacturers along the path of development to ensure their products are free from nitrosamine contamination.

Rapid sample analysis using AEMS technology improves bioanalytical study turnaround

In this study, HEK293F cells grown in scale-X bioreactor produce >3x higher AAV-2 vector, with 25-52% lower cost than the reference process.

End-to-End Workflow Solutions for Oligonucleotide Analysis - From research discovery to production QA/QC