Whitepapers

Learn about the importance of considering human factors testing beyond the initial validation phase. Through two case studies, it illustrates how seemingly minor product changes can trigger regulatory scrutiny. The message is clear: proactive testing and expert guidance are essential to navigate regulatory requirements effectively.

Raw material testing is critical for drug development, ensuring safety and efficacy. Look for a partner with extensive compendial experience, ample capacity, fast turnaround times, digital capabilities, modality expertise, global presence, regulatory compliance, and a focus on value.

EBPT Toronto expands Eurofins BioPharma Product Testing's North American presence, offering comprehensive product testing services in Toronto. With a focus on cGMP compliance, the facility provides chemistry, microbiology, and regulatory consulting services, including testing for controlled substances. It ensures consistent quality across its network, prioritizing customer satisfaction and regulatory compliance throughout the drug development process.

The Toxicology Team in Lancaster now offers expanded services including biological evaluations to help clients with biocompatibility strategies and regulatory compliance. We provide tailored consulting for specific needs like mitigating biological risks due to product changes or failed tests. Each project is evaluated individually, ensuring customized solutions and enhanced client value.

Eurofins BioPharma Product Testing in Lancaster, PA, is a leader in ensuring the quality and safety of cell banks used in biomanufacturing. Certified by regulatory agencies like the FDA and TGA, EBPT's Cell Banking Department operates under stringent quality standards. We employ controlled processes, including employee training and contamination control, to maintain quality. With global certification, EBPT's laboratories are equipped to meet manufacturing needs worldwide.

EBPT provides expert support for Environmental Monitoring programs, ensuring clean and controlled manufacturing environments. Our services include designing monitoring programs, collecting samples, and analyzing data using advanced equipment. With locations across the U.S., EBPT offers nationwide support to pharmaceutical and medical device clients with standardized practices and specialized expertise.

Having a robust Cell Line Development (CLD) strategy is the foundation of biologic production that can propel a project, helping to streamline production while mitigating risk. A tailored and optimized cell line can be instrumental in overcoming development and manufacturing challenges and achieving a competitive advantage in the market with streamlined manufacturing processes. In this eBook, Bora Biologics describes how a robust CLD strategy can help biologics developers anticipate and overcome challenges and streamline production.

See how stability of a formulation in Woodstock Sterile Solutions’ primary container design compares to glass vials.

Is blow-fill-seal technology the right fit for your pharmaceutical product? Download our checklist to find out. 

Well-designed analytical testing of biologics is essential during every stage of biopharmaceutical development to ensure the safety and quality of the drug and provides an important feedback loop during development. In this article, Bora Biologics delves into the significance of rigorous analytical testing, highlighting strategies to meet regulatory standards and enhance processes effectively.

Complex formulation development presents unique challenges. Download this white paper for three key considerations.

Choosing the right CDMO is a strategic decision that can significantly impact the success of biologics development. By evaluating a CDMO’s ability to adapt programs to specific protein therapies and manufacturing needs, leverage specialized expertise, offer integrated solutions and overcome industry challenges, manufacturers can make informed decisions that maximize their chances of project success. In this article, Bora Biologics explores how a strategic approach — adapting programs for specific proteins and customer needs — can be beneficial in achieving the customer’s biologics development goals for novel therapeutics or biosimilars.

Tumble blenders deliver highly accurate and repeatable mixing of powders, granules and even low-viscosity slurries. In addition, this style blender enables complete discharge and easy cleaning. This bulletin presents some design considerations for maximizing mixing efficiency in a tumble blender and selecting the most suitable features for a particular application.

Consider upgrading your emulsification process to an ultra-high shear mixer to obtain finer droplet sizes and handle higher viscosity emulsions.

This white paper presents an overview of mixing technologies implemented across many of today’s highly competitive pharmaceutical and medical industries, as well as new equipment designs that are increasingly being recognized as potential solutions to prevailing mixing challenges. Mixing applications falling within the broad spectrum of mass produced pharmaceutical goods and medical devices are too many and complex to discuss in detail hence this paper will touch on a few general classifications as well as a few examples within that mixing category. Phase and viscosity are used as bases for classification.

Read about the process utilized and results gained from the use of a two-phase scale-up strategy to manufacture three complex dry powder medium (DPM) formulations. The success of these projects relied on consistently producing acceptable prototype and cGMP material within the customer’s specifications and manufacturing timelines.

The importance of successfully scaling up cell culture media cannot be overstated. Not starting the process soon enough can introduce issues with solubility, manufacturability, procurement, and cost management. This article considers technical and commercial best practices that drug developers may enact so that they, their suppliers and media manufacturers, and in turn, their cell culture media remain on the most efficient path to market.

Sterile injectables (SI) and complex biologics can be leveraged from both a technical and business development standpoint. Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates.

When evaluating a potential vendor, whether for a catalog medium or custom formulation manufacturing, it is important to ensure it can meet your unique needs. This article details five top considerations to carefully evaluate when selecting a cell culture media supplier. Learn how to maximize confidence in your media supply, optimize productivity and help achieve long-term efficiency.

In this project, Thermo Fisher Scientific worked with a multinational biopharmaceutical company to investigate trace element variability in its custom cell culture media. Within a year, using a risk-based, collaborative approach, both teams were able to thoroughly characterize incoming specific raw materials and implement proactive measures for reducing the risk of impurities, ultimately providing the company with a long-term risk mitigation strategy.

Kindeva’s microneedle array patch platforms for solid and liquid APIs have the potential to deliver far-reaching clinical, environmental, and usability benefits.

In the decades since its creation, the autoinjector has changed lives globally. This article charts evolutions in this essential device, including considerations for today’s next-generation autoinjectors.

Our facility in Bridgeton, MO, delivers Annex 1 compliance with every line. Along with our other facilities in the St. Louis area, this site makes us one of only a few CDMOs capable of servicing sterile fill, device manufacture, and final assembly in one geographic location. This saves you time and money while reducing your carbon footprint.

Compliance and quality are not the same thing. While compliance means manufacturers demonstrate they meet regulatory requirements, quality is foundational to patients’ confidence in the safety and effectiveness of their medications.

Continuous Manufacturing in pharmaceuticals can increase process understanding while overcoming disadvantages of batch manufacturing: slow and expensive development and tech transfer, plus inefficiencies, product loss, and human error in commercial manufacturing.

What innovations can help drug manufacturers and developers mitigate risks, reduce turnaround time, and increase success in early phase Cell & Gene therapy development?

Lonza Small Molecules is focused on leveraging its technologies and expertise to address solubility challenges and support drug development programs through commercialization.

Implementing automation involves careful optimization and fine-tuning of various parameters to ensure the accurate execution of cell-based potency assays.

Sara Greco, R&D Chemist at Valsynthese, part of the SSE Group, covers the beneficial properties of polyimide materials and the key role that aliphatic anhydrides play in the enhancement of those properties.