Business

DNA to IND in 13 Months: A CMC Strategy for Bispecifics

Multichain protein biotherapeutics such as bispecific molecules have been developed to treat cancer, neurological and ophthalmic disorders, and autoimmune and inflammatory diseases. Early successes now are driving greater numbers of such molecules toward clinical evaluation and commercial approval. However, the complexity of bispecific development and manufacture calls for innovative tools and technologies to facilitate the clinical journeys of such products and prevent costly setbacks for their sponsors. In its commitment to fostering novel biomolecular formats, Lonza has designed a chemistry,…

US Patent Law: A 20-Year Retrospective

The past 20 years have been extraordinary for intellectual property law. Most of the transformations can be attributed to changes in the statute, US Supreme Court jurisprudence, almost complete turnover in judges in the Court of Appeals for the Federal Circuit (“Federal Circuit,” below), and advances in technology that could not have been anticipated in 2002. An understanding of those changes requires a retrospective of patent law over those 20 years. At that time, the Federal Circuit was 20 years…

Expanding Considerations in Cleaning Validation: Risks Posed By Indirect Product-Contact Surfaces on Pharmaceutical Equipment

Cleaning validation receives a great deal of attention within the biopharmaceutical industry, not least because of the risks of product adulteration and hence patient harm from improperly cleaned surfaces (notwithstanding additional concerns such as operator protection). Traditionally, cleaning validation efforts focus on direct product-contact surfaces. However, the hazard and resultant risk posed from indirect product-contact surfaces should not be underestimated. Consideration of the risks presented by indirect surfaces should figure into every contamination-control strategy. Understanding of these risks cannot be…

From Immigrant to Entrepreneur: Lessons Learned in Building an Innovative Business

As an entrepreneur, I stepped away from a fulfilling position in a large and established company to go out on my own and build something new. My decision to leave the advanced research department at Illumina, Inc. to create a start-up might seem like an extreme leap, but I am very familiar with the risks of starting over. After earning my bachelor of science degree in biotechnology from the University of Tehran, I immigrated to the United States. I left…

Building a Solid Foundation for a Pharmaceutical Quality System: Presenting QRM and KM As United Enablers

Risk, knowledge, uncertainty, decision-making: They are among the building blocks at the center of the biopharmaceutical industry that guide the daily operations of biopharmaceutical organizations, from the work of scientists during discovery to technicians manufacturing each batch. Indeed, the biopharmaceutical industry is a knowledge-based industry in which organizations satisfy patient needs while gaining competitive advantage by their ability to grow, transfer, and apply knowledge rapidly and effectively. Many people who read the word knowledge have a certain implicit interpretation of…

Market Growth for Biopharmaceutical Media, Sera, and Reagents

Bioprocessing materials such as cell-culture media, sera, and reagents are used in the development of different drug products such as recombinant proteins, immunotherapies, and regenerative medicine. Biopharmaceutical research materials include DNA/RNA isolation reagents, chemicals, buffers, stains, and washing solutions. Media provide nutrients essential for cell growth in culture. Advancements in culture media (both serum-based and serum-free) have enabled researchers to culture different types of cells and microorganisms, including mammalian and bacterial host cells for protein expression (e.g., Chinese hamster ovary…

BioProcess Insider Interview: Emmanuel Ligner, Cytiva

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Emmanuel Ligner, Chief Executive Officer, Cytiva. In 2021, Cytiva collaborated with London’s Financial Times survey group to establish an annual biopharmaceutical industry resilience index. Ligner explained that his company spearheaded the project to quantify life-science leaders’ confidence in the industry and to identify areas for improvement. The inaugural survey collected impressions from more than 1,000 executives about supply-chain resilience, talent recruitment, research and development activity, manufacturing agility, and regulation. The industry…

The Evolving Manufacturing Landscape: Reflections from PDA President and CEO

The past 20 years have been a period of rapid change and development in the world and in the biopharmaceutical industry. One of the biggest changes has been the introduction of a pathway for biosimilars in the decade after 2010. Before that, no provision for “generic” versions of biologics existed. The European Medicines Agency (EMA) approved the first monoclonal antibody biosimilar in 2013, and the US Food and Drug Administration (FDA) followed with its first approval in 2015. Those approvals…

Transforming the Biopharmaceutical Development Roadmap

Biopharmaceutical analytical methods have improved significantly since the early 1990s. Techniques and fundamental mechanisms largely have remained the same, but modern analytical tools are delivering better insights into drug-product characteristics thanks to improved reagent quality, method intensification, and automation. Harmonized regulations and the revolutionized role of contract development and manufacturing organizations (CDMOs) also continue to support bioprocess transformations. Improved Analytics and Standardized Single-Use Equipment Today’s analytical methods provide high resolutions and deliver reliable results quickly. For example, sodium dodecyl sulfate–polyacrylamide…

20 Years of Chemistry, Manufacturing, and Controls Strategy. A Conversation About the CASSS CMC Forum Series

Formerly known as the California Separation Science Society, the CASSS organization has maintained a close relationship with BioProcess International since its inaugural year. In particular, the CMC Strategy Forum series began the same year that BPI’s original staff joined Informa to develop a new international trade publication covering biopharmaceutical development and manufacturing. Beginning with our February 2004 issue, BPI has been proud to publish dozens of reports from this influential series of meetings over the years. Their success around the…