Whitepapers

Buffers are used in great quantities when producing monoclonal antibodies (mAbs), and many biopharmaceutical companies — even large ones — do not have the processing capacity or infrastructure in-house to handle these large volumes. Whether it’s providing quality, pre-weighed, GMP-compliant raw materials or the entire buffer preparation step, there are options available to optimize your process.

As the most expensive stage of monoclonal antibody production, downstream processing presents numerous opportunities to increase efficiency and raw material performance. This article discusses advances in purification process materials, as well as emerging technologies to aggregate and analyze data, as possible solutions to these challenges.

Lipid-based formulations can improve the oral bioavailability of some molecules. However, a poor understanding of the technology and complexities limit their use.

It is essential to have access to the right tools and expertise to support process development for biologic therapies, from the clinical trial phase to commercialization.

Experic’s latest article looks at new initiatives aimed at fostering the development of biologics delivered via inhalation, an emerging field. While manufacturing technologies have advanced to support this sector, several challenges remain, including an unclear regulatory pathway.

When you’re partnering with a design firm to support your product development and manufacturing needs through automation, it’s important to decide whether you should work with a systems integrator or an automation design engineering firm.

When establishing or expanding services to support new drug development, pharmaceutical and biotech companies find that automating their processes increases efficiency, maximizes capital, reduces costs, and expedites time-to-market.

Automation systems can increase efficiency, reduce time to market, and improve facility and operational performance. Support from a life sciences-focused design firm with experience in cGMP requirements will help you tailor your system to your specific process, facility, and operational needs.

Eurofins BioPharma Product Testing (EBPT) in the US is a leading entity in the analytical testing of Cell and Gene Therapy, with its involvement dating back to 2010 at the Eurofins BPT Lancaster, PA location. Over the past decade, EBPT has developed a comprehensive business strategy catering to the analytical industry's needs, covering Raw Materials, Cell Banks, Plasmids, Viral Vectors, Genetically Modified Cells, CAR-T drug products, and iPSCs. The company has actively supported the growth of Cell and Gene Therapy through strategic investments, including the adoption of innovative technologies like droplet digital PCR, Analytical Ultracentrifugation , and Transmission Electron Microscope testing. These investments also involve dedicated facilities at various locations across the US.

Helium has been the preferred carrier gas for gas chromatography (GC) testing, but its finite supply, environmental impact, and recent supply chain issues have prompted Eurofins Lancaster BioPharmaceutical Chemistry teams to actively seek alternatives and reduce helium usage in laboratories. Conservation efforts include evaluating gas chromatography methods, checking for helium leaks during audits, and avoiding idle periods between analytical runs. Nitrogen and hydrogen are explored as alternatives, with challenges noted. Eurofins is committed to developing strategies to conserve or eliminate helium usage, recognizing the importance of reducing reliance on this non-renewable resource in the industry.

Eurofins acknowledges the significance of Cell and Gene Therapies, particularly Autologous Cell Therapies , in the healthcare industry. Recognizing the urgency associated with short shelf-life products, Eurofins BioPharma Product Testing has developed a comprehensive set of services to address the need for swift and reliable testing. This suite of services positions Eurofins as a one-stop-shop for rapid and facility testing requirements. Clients can benefit from guaranteed short turnaround times while maintaining the highest quality standards for tests crucial in ensuring the safety of Cell and Gene Therapies for patient administration.

The FDA's Office of Combination Products recently finalized guidance emphasizing the critical role of human factors engineering (HFE) in the development of combination medical products. Eurofins Human Factors MD highlights the importance of a robust HFE program, stressing its necessity rather than being optional. The guidance recommends considering combination products as parts, conducting a separate Use-Related Risk Analysis, and identifying meaningful critical tasks. It provides clarity on participant training in HFE validation tests based on UI design requirements. The document encourages manufacturers to address unique attributes of combination products and recommends a pre-submission review of the HFE validation protocol with the FDA to mitigate risks in marketing submissions.

Container-Closure Integrity (CCI) is essential for ensuring the stability and safety of drug products over time. The USP recommends deterministic methods over older probabilistic ones like dye ingress, emphasizing the need to assess the significance of leakage in relation to product quality. Eurofins can assist in choosing and validating appropriate CCI testing methods tailored to specific product and closure system configurations, as there is no one-size-fits-all solution outlined in the USP.

In the drug development process, drugs undergo a rigorous journey from target identification to new chemical entity identification, involving the screening of tens of thousands to potentially hundreds of thousands of compounds. Preclinical pharmacology and toxicology play crucial roles in translating laboratory findings to clinical applications. Toxicology studies, conducted in accordance with Good Laboratory Practices , assess the impact of pharmaceuticals on biological tissues and living animals, mimicking anticipated human exposure routes. Eurofins BPT, based in Jacksonville, FL, supports both toxicology and clinical trial material (CTM) requirements by preparing scaled-down batches using formulations and processes akin to finished products. In San Diego, CA, Eurofins BPT employs a state-of-the-art fill-finish facility with a gloveless, robotic isolator for sterile CTM filling, ensuring optimal sterility through real-time data monitoring and minimizing contamination risks.

This case study summarizes the outcomes of several media optimization projects and how the results helped manufacturers to achieve their desired scale-up goals, including enhancing productivity, maintaining product quality, and potentially improving return on investment (ROI).

Media manufacturers must offer global redundancy at harmonized manufacturing facilities to enable streamlined capabilities–especially for their customers outsourcing proprietary cell culture media formulations. This paper details Thermo Fisher’s manufacturing equivalency approach utilized at two global facilities located in Miami, Florida, and Grand Island, New York.

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.

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.

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 Cubis®️ II balance, equipped with a pharma package, provides technical features for regulatory compliance in pharmaceutical quality control. Complete compliance requires extra procedural controls and data storage systems. Our checklist highlights key regulatory details and shows how Cubis®️ II facilitates full pharma compliance.

Viatel™ Ultrapure polymers: High-purity, controlled-release polymers for improved consistency and extended durations in long-acting injectables and implants (LAII). With a proprietary purification process, residual monomer is reduced to <0.5%, ensuring reproducible performance and a more neutral pH environment. These GMP-grade polymers, with typical batch results of 0.1% monomer content, offer formulators greater versatility in addressing complex formulation challenges, reflecting Ashland's commitment to continuous improvement in response to customer needs.

Pharma companies must comply with pharmacopeia regulations, like the USP for the US and Ph.Eur. for Europe, to market drugs. The USP has long had a chapter on lab balances, while the Ph.Eur. introduced a similar mandatory chapter in January 2022. Our infographic compares lab balance rules in both pharmacopeias, noting their differences.

The European Pharmacopoeia's new Chapter 2.1.7 on analytical balances was published on July 1, 2021, and became mandatory for pharma companies in Europe from January 1, 2022. It outlines calibration and performance standards for balances. Our white paper compares this with USP Chapters <41> and <1251>.

The European Pharmacopoeia's new section 2.1.7 on analytical balances was released in July 2021 and enforced from January 1, 2022. It's a mandatory standard for pharmaceuticals in Europe. Download our FAQ for compliance tips and how our Cubis® II lab balance can help.

Solubility of the active pharmaceutical ingredient (API) in an oral formulation is critical for absorption from the gastrointestinal (GI) tract and the intended therapeutic effect. Ensuring that an API has the necessary solubility can be challenging for drug developers and formulators. If limitations in solubility cannot be successfully addressed, a new chemical entity (NCE) is unlikely to advance in the development pipeline. Addressing this potential roadblock to clinical success is becoming increasingly important as NCEs continue to become larger and more lipophilic and, as a result, less soluble.

Explore the potential of next-generation genome editing tools for driving the success of monoclonal antibodies for biotherapeutics.

Explore how Samsung Biologics’ DEVELOPICK™ can help mitigate development risk and identify candidates with the best potential for advancement to IND and beyond