Manufacturing

Cleaning Validation: Increasingly Under the Regulatory Spotlight

The steps involved in manufacturing pharmaceutical products require rigorous processes to ensure the safety of patients. One important such process is cleaning validation — a critical element in current good manufacturing practice (CGMP). The US Food and Drug Administration (FDA) defines the purpose of cleaning validation as demonstrating that a “particular cleaning process will consistently clean the equipment to a predetermined standard” (1). And according to the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), “cleaning validation is documented evidence that an approved…

Simplifying the Route to GMP with a
Risk-Based Approach to Single-Use Implementation

Adopting single-use systems (SUS) is an attractive solution for current challenges within the biopharmaceutical industry. However, before implementing single-use solutions, biomanufacturers must ensure that the required SUS product quality attributes are met. In this special report, subject-matter experts from Sartorius provide insights into SUS implementation strategies for biopharmaceutical manufacturing. Their discussion covers four pillars: forming a regulatory strategy, addressing flexible radiation-sterilization processes, assessing extractables and leachables (E&L), and assuring system integrity and robustness. Then, the writers present a case study…

ADC Development and Manufacturing: Simplify, Derisk, and Accelerate the Timeline

Antibody–drug conjugates (ADCs) are complex therapeutics that offer a unique combination of selectivity and potency. Commercial demand for ADC therapeutics is projected to continue to increase while facing a very complex development, manufacturing, and supply chains challenges. Given the complexities of ADC development and manufacturing, there are clear advantages to partnering with a single contract development and manufacturing organization (CDMO) that offers a complete set of services. As ADCs continue to grab a larger share of clinical pipelines, it becomes…

eBook: Flexible Facilities — Exploring Hybrid Biomanufacturing Strategies

Flexibility is a primary consideration in today’s biopharmaceutical industry. Drug companies must develop and ultimately manufacture increasing numbers of therapies, many of which treat indications with smaller patient populations than those addressed by “blockbuster” drugs. For such reasons, facilities outfitted with fixed, large-volume stainless-steel equipment are becoming less conducive to meeting current and projected business goals. Single-use technologies would seem to provide added flexibility, although the goal of implementing fully single-use operations remains impractical for many facilities. Hence, companies are…

The Legacy and Future of Genomic Medicine: From the 15th Annual State of Personalized Medicine Address

The Personalized Medicine Coalition met in Washington, DC, in May 2023 to commemorate the 20th anniversary of the Human Genome Project’s completion. Eric Green, director of the National Human Genome Research Institute (NHGRI), has been a key contributor to the fields of genomics and personalized medicine for more than three decades. According to Lincoln Nadauld, cofounder and chief executive officer (CEO) of Culmination Bio, Green’s work has “included significant involvement in the Human Genome Project, during which he and his…

Creating Value As a CDMO

As a contract development and manufacturing organization (CDMO), Aton Biotech provides a comprehensive set of services to clients developing biological drugs. Those services range from cell line development to clinical development and end-to-end commercial manufacturing. A Long History Aton emerged from a biopharmaceutical company called Henlius that was established in Shanghai, China, nearly 13 years ago. Today, Henlius has five products on the market including rituximab, trastuzumab, and adalimumab. From the beginning, company leadership decided to build internal manufacturing capacity…

Navigating Diverse Production Challenges: Four Routes to Success

The biopharmaceutical industry is facing continued pressures to bring high-quality drugs to the market quickly while limiting costs and meeting challenging sustainability targets. However, companies might lack the expertise, resources, and time required to establish, optimize, and scale up tailored, efficient processes that meet market demands. Process consultancy services and preengineered solutions are excellent resources that bring in new perspectives and expertise, regardless of your specific end goals. Here, we outline four key objectives, the challenges associated with meeting them,…

Managing Complex Considerations with Pharmaceutical Facility Design

Delivering safe and effective therapies starts in facilities that are built and maintained with safety and compliance in mind. US Food and Drug Administration (FDA) and European Commission (EC) regulations often are presented as broad guidelines that describe what manufacturers need to account for, but they are not always prescriptive because facilities have unique needs. In a September “Ask the Expert” webinar, Gerardo Gomez and Patrick Nieuwenhuizen of PharmaLex Solutions demystified the guidelines that bioprocessing companies should follow. The Presentation…

Overcoming Obstacles in Viral-Vector Manufacturing: How To Design and Launch a Successful Program for Clinical-Trial Manufacturing

Experience with manufacturing viral vectors used for gene therapeutics is essential to mitigating risks in manufacturing of clinical trial materials. Collaborating with an experienced contract development and manufacturing organization (CDMO) with can help product developers design seamless and scalable vector-production processes. As authors from IDT Biologika describe here, a proven manufacturing platform and high-throughput analytical technologies help to ensure patient safety with products that meet high quality standards. The authors highlight the utility of digital polymerase chain reaction (dPCR), anion-exchange…

Modeling Interventions Against Antimicrobial Resistance

Antimicrobial resistance (AMR) poses a serious public health threat that affects people all around the globe. Although methicillin-resistant Staphylococcus aureus (MRSA) poses a well-understood risk, problems with AMR span beyond that bacteria. Predicting the Impact of Monoclonal Antibodies and Vaccines on Antimicrobial Resistance (PrIMAVeRa) is a program that seeks to help estimate the burden of disease attributable to AMR, which is a complex problem that requires high-quality surveillance data. A recent global study linked 4.95 million deaths to bacterial AMR in…