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CMC Strategies for Expedited Program Development — Regulatory Perspectives: Session 1 of a CMC Strategy Forum

In response to increasing demands for expedited availability of biotherapeutics around the world — and with the ultimate goal of patient benefit — health authorities have developed accelerated regulatory pathways to reduce development timelines to product licensure. Because of the complexity and unique nature of each program and product modality, some solutions must be worked out case by case between sponsors and regulatory agencies. On 13 October 2020, CASSS–Sharing Science Solutions presented a virtual session overviewing currently available regulatory pathways…

Managing Host-Cell Proteins: Robust Risk-Assessment Frameworks for Process-Related Impurities in Biological Products

Although biomanufacturing processes are designed to generate highly pure drug substances, some host-cell proteins (HCPs) copurify with target proteins and thus remain in finished drug products. Biopharmaceutical developers are keenly aware that such impurities must be minimized to protect patients. HCPs can activate several kinds of immune responses in treated patients, including production of antidrug antibodies and induction of cross-reactivity with therapeutic proteins (1–5). HCPs also can diminish drug efficacy, potency, and/or stability (6, 7). Thus, regulatory guidances such as…

Growing Value of Artificial Intelligence in Biopharmaceutical Operations

Some people have found significant disillusionment regarding artificial intelligence’s (AI’s) limitations in application. For example, mass-media productions (e.g., Ex Machina) encourage the goal of achieving general AI or super AI, which supplies comprehensive, self-instituted results. In truth, narrow AI — which addresses only one task and provides specific results — is growing rapidly, both in power and number of applications (1). Although many different modeling methods remain dominant, AI is providing significant and increasing value in drug discovery, process development,…

Plant-Based Protein Expression: Emerging Systems Bring Viable Approaches to Biopharmaceutical Manufacturing

The application of plant-based systems to produce biopharmaceuticals for human and veterinary indications is a rapidly expanding field. Available systems range from stable transgenic root-cell culture to transient expression in whole plants. Products that have been expressed include monoclonal antibodies (MAbs) (1), subunit vaccines (2), virus-like particles (VLPs) (3), specialty enzymes (4), and structural proteins such as collagen (5). “Traditional” bioproduction platforms such as Chinese hamster ovary (CHO) cells, Escherichia coli, and Pichia pastoris have long histories of patient safety…

Certified Reference Mixtures in Extractables Screening of Polymeric Materials: For Container–Closure Systems and Single-Use Equipment

Plastics have been used for decades in container–closure systems (CCS) for drugs and in single-use (SU) manufacturing equipment for biopharmaceutical processing. Biomanufacturers must comply with national and international laws and regulations that require proof that use of such polymeric materials is safe (1, 2). That necessitates testing for potential biological responses and interactions with drug substances. Comprehensive extractables and leachables (E&L) studies also are required for potential release of undesired compounds from polymers. Extractables tests are performed on materials under…

Ending CO2 Transmission Problems Using Purillex® Containers

This webcast features: Eric Isberg, Vice President, Life Sciences, Savillex. Ingress of carbon dioxide into bulk drug substance (BDS) containers that are stored and shipped on dry ice is a serious and often understated problem. This webinar outlines two studies performed by a major biopharmaceutical company to determine the closure style and torque specification of Purillex® PFA bottles required to ensure no carbon dioxide ingress during storage and shipping of BDS products on dry ice. Key takeaways: Understand the correlation…

For resins, supply chain resilience is key, says Purolite

As the demand for resins rises in the bioproduction space, BioProcess Insider spoke to Hans Johansson, global applications director at Purolite to find out the challenges they face and what they are doing to overcome them. BioProcess Insider (BI): Let’s get right back to basics. What are bioprocess resins and how are they made? Hans Johansson (HJ): Depending on the molecule requiring purification, chromatography resins are typically leveraged to optimize purity and yield. Chromatography in bioprocessing aims to accomplish three…

Vertex doubles down on Massachusetts CGT capabilities

Vertex Pharmaceuticals announced it will build a $595 million facility during the dedication of its Center for Cell and Genetic Therapies building in Boston this week. Vertex became a serious player in the advanced therapy space in 2019 through a series of deals, including the $245 million acquisition of Duchenne muscular dystrophy and myotonic dystrophy type 1 gene therapy developer Exonics, and the $950 million acquisition of type 1 diabetes stem cell developer Semma Therapeutics. The same year, the firm…

FDA issues draft guide to tackle supply chain disruptions

The FDA says that implementing risk management principles should be applied throughout the drug supply chain to help mitigate the risk of shortages. “Today’s draft guidance is an important step in what the nation needs to achieve an increasingly secure and resilient drug supply,” the US Food and Drug Administration (FDA) said in a statement. “For Americans to have access to an uninterrupted supply of safe, effective and high-quality drugs, all entities involved in the manufacture of a drug should…

BPI Europe: Questions surround mRNA’s life beyond COVID-19

Messenger RNA (mRNA) might not become as dominant a modality as its COVID-19 success suggested, according to a senior consultant at Merck KGaA. David Loong, senior consultant for novel modalities at Germany’s Merck, made the comments during a panel discussion at BPI Europe in Vienna, Austria this week. Unsurprisingly, the COVID-19 pandemic has “completely skewed” how mRNA could be applied, he said. With the likes of Moderna and BioNTech/Pfizer releasing successful and respective vaccines, the application of mRNA technology was…