Whitepapers

High pressure homogenizers, such as NanoGenizer, prepare nanomaterial by producing high flow velocity through a small orifice, using a specially designed internal fixed geometry under high pressure from 10,000psi to 40,000 psi. During the homogenization process, changes in physical, chemical, structural properties occur, and as a result, homogeneous suspension takes place at nanoscale. The pressure of a conventional homogenizer is within 15,000 psi, while a high pressure homogenizer can achieve 30,000 psi, and an ultra-high pressure homogenizer can reach up to 60,000 psi.

Learn more about the Capsugel® Enprotect® capsule and our breakthrough enteric manufacturing technology.

Learn more about the Capsugel® Enprotect® capsule and our breakthrough enteric manufacturing technology.

This article presents a new PAT to overcome the current market needs, capable to monitor the advance of the sublimation front temperature interface using single-use wireless probes.

Procipient ® (Dimethyl Sulfoxide USP, PhEur ) is the only compendial DMSO specifically for pharmaceutical use. Procipient is supported with the proper documentation required by pharmaceutical regulatory authorities.

The objective of this white paper is to discuss the suitability of this versatile excipient in parenteral drug products and provide an updated summary of regulated parenteral drug delivery products in which DMSO is incorporated. It will also summarize emerging technologies in which DMSO is instrumental, primarily in the formulation / delivery of peptide drugs and biopolymers.

Learn more about several innovative techniques that can shorten time-to-market, reduce development costs, increase yield, and assure quality and pharmacopoeia compliance throughout the drug development process.

In the pharmaceutical industry as a whole, the reliance on a virtual drug development model that involves global outsourcing of CMC activities has greatly increased.

This webinar highlights the development of the first chemically defined microbial medium. Designed to simplify workflows and achieve high density cultures, the Gibco™ Bacto™ CD Supreme supports advancements in therapeutics, gene therapy, and vaccine development. Discover data shared by experts and explore how you can improve process productivity and reduce risks.

The animal origin-free (AOF) trend in bioprocessing has taken a while to reach microbial bioproduction. In this podcast, we explore the reasons behind this and delve into how AOF products are impacting the future of biopharmaceutical manufacturing. We also discuss the first chemically defined microbial medium—the Gibco™ Bacto™ CD Supreme Fermentation Production Medium (FPM). Hydrolysate-free and AOF, this dry powder medium was specially designed to support high-cell-density cultures of E. Coli. Listen to bioprocessing experts and discover more.

Accelerate your viral vector and vaccine development with high-performance media, supplements, services, and support. Discover our extensive, cutting-edge portfolio, including Gibco™ Bacto™ CD Supreme, the first chemically defined microbial media, designed to support high cell density cultures of E. coli. Read the brochure to explore how you can optimize your workflow, while minimizing risks and improving cost effectiveness.

When choosing a CDMO to work on a project, there are a number of important areas to consider prior to making a selection

Despite the long-standing popularity of E. coli for microbial bioprocessing, the options for growth media have been traditionally limited. This media has often included animal origin (AO) components which can reduce batch-to-batch consistency and present safety risks to patients. Significant effort from across the industry has been focused on developing the first commercially available chemically defined microbial media. Read the article and learn how the Gibco™ Bacto™ CD Supreme Fermentation Production Media is helping to manufacture the next generation of biopharmaceuticals.

The cell and gene therapeutic market is growing substantially and finding a way to increase manufacturing capacity while maintaining high-quality standards poses a unique challenge. With a focus on maintaining consistency, utilizing a fully chemically defined medium, such as Gibco™ Bacto™ CD Supreme, can help to mitigate variability risks. Read the whitepaper to explore scalable process workflow solutions available from initial R&D investment to clinical testing, and commercialization.

Timely progression of a drug candidate into clinical trials is critical for pharmaceutical companies seeking to bring new products to the market. Streamlining chemistry, manufacturing, and controls (CMC) development can help accelerate this process, as well as help yield better success as the drug product moves through the early phase of clinical studies.

Eurofins BioPharma Product Testing’s Biologics Raw Materials testing team has vast experience in cell & gene therapy testing, including evaluating critical quality attributes for ancillary and raw materials.

For all stages throughout the development, manufacturing and release of your biological product, Eurofins BioPharma Product Testing offers comprehensive, fully cGMP-compliant Viral Safety Services, including characterization of cell banks, unprocessed bulk testing, end of production cells, and raw materials testing.

Eurofins BioPharma Product Testing supports the development of cell & gene therapies by providing comprehensive GMP-compliant CMC testing support to ensure the identity, potency, purity, and safety.

A panel of experts from bio/pharmaceutical companies discuss plasmids to establish specifications using a risk-based approach to manage supply, including the response to cell & gene therapy industry feedback, future outlook and re-evaluating plasmid risks.

Scaling production of mAb drugs remains a critical industry challenge – especially in downstream process chromatography steps. This Avantor White Paper details how technologies such as a novel protein A chromatography resin and the use of additives can improve efficiencies in this complex process step. It also reveals the potential for expanding single-use and continuous processing systems to help further streamline downstream production and improve cost profiles.

Finding more efficient ways to reduce processing times and improve downstream yields is a major bioprocessing industry challenge. In this study, two mAbs chromatography resins were examined. Both were used for a capture step, and additives were screened to reduce the nonspecific binding of impurities. The goal of the study was to optimize chromatography steps and thus increase the capacity and removal of impurities.

Traditionally, Oncology trials placed a heavy burden on patients due to travel burden, poor patient experience and multi-year clinical trial commitments. Sites also struggle with cancer trials due to enrollment delays, complex data workflows, and multiple amendments requiring re-consents. Today, we have a more effective, patient-first solution. Optimize patient choice, improve retention and safety with Patient- First Oncology solutions that meet patients where they are.

This white paper will describe the critical factors to consider for the identification and implementation of catalytic processes using supported Platinum Group Metal (PGM) heterogeneous catalysts. Many variables influence catalyst performance. The paper will provide guidance for catalyst selection and how through an in-depth analysis can lead to process optimisation.

The successful transition of drug products between developers and manufacturers is equal parts science and art, defined by enabling processes, a culture of collaboration to support them, and, perhaps most important, a foundation of trust.

Risky Assumptions for Addressing Limited Bioavailability

Whether it’s for scaling-up, moving to another facility, or moving to another outsourcing partner, technology transfers are part of the normal course of business. Learn about the 9 dos and don’ts of executing a successful technology transfer.

Small molecule drug development has changed substantially in recent years. With the heightened focus on molecularly targeted therapies, small molecule active pharmaceutical ingredients (APIs) and drug products are more complex and potent than ever, requiring increasingly specialized manufacturing processes and drug delivery solutions. At the same time, the competitive demand for rapid entry into clinical development—combined with accelerated review pathways—translate into compressed manufacturing and delivery timelines.

Outsourcing projects to CDMOs is becoming increasingly prevalent as drug sponsors look to optimize their supply chain or conserve internal resources for other projects. In 2021 alone, 46% of newly developed drugs were outsourced. Drug sponsors can reap a variety of benefits by outsourcing late-phase projects, but it comes with risks. The technology transfer that must occur to transition a late-phase project to a CDMO is complex and costly. The average cost of a tech transfer is around $1M, so partnering with the wrong CDMO can be a costly mistake.