Supply Chain

How To Achieve DSCSA Compliance by November 2023

As the world surges into the new year, pharmaceutical companies that manufacture pharmaceuticals in and/or for the United States seeking to comply with the Drug Supply Chain Security Act (DSCSA) may find themselves scrambling to meet the 27 November 2023 deadline requiring them to track and trace prescription drug products within the supply chain. Congress enacted the 60-page DSCSA in November 2013 as Title II of the Drug Quality Security Act (DQSA) to protect patient safety. That provided the pharmaceutical…

Cell Therapy — Supply Chain Discussions

The 2017 approval of Kymriah (tisagenlecleucel) has paved the way for other cell therapy products to reach the patients who need them. Each passing year promises to open the regulatory floodgates to more product approvals, but technical and manufacturing issues continue to keep initially high expectations from being realized. One barrier is supply chain complexity, especially for the subset of autologous cell therapies. This eBook features expert commentary from Be The Match BioTherapies, a company providing more than 50 product…

Managing Patient Data in the Supply Chain

The personalization of autologous advanced therapy medicinal products (ATMPs) makes patients an intrinsic part of the supply chain. It begins with collection and registration of starting materials, which necessitates tracking and recording chain-of-identity (CoI) and chain-of-custody (CoC) information for every dose. This situation could expand the challenges of patient data management throughout the whole supply chain, increasing data privacy risks to both patients and suppliers. ATMP manufacturers must therefore protect data privacy not only as clinical trials start, but also…

Future Supply-Chain Needs for Allogeneic Cell Therapies: Why Strategic Partnerships Are Critical

Allogeneic products are an attractive option for cell-therapy developers because multiple batches can be manufactured using apheresis material collected from one healthy donor — and because the resulting therapies could be made available as off-the-shelf products. The appeal of this approach is apparent from growth in allogeneic-therapy development. According to the Alliance for Regenerative Medicine, the number of clinical trials for allogeneic cell-based cancer treatments has increased by 30% over the past five years. Early in 2022, allogeneic candidates accounted…

How Our Partnerships Move Your Life-Changing Biologics to Market: Two Case Studies

Muctarr Sesay, chief scientific officer, Goodwin Biotechnology. Goodwin Biotechnology’s mission is to minimize manufacturing risks associated with complex biopharmaceuticals, including antibody–drug conjugates (ADCs), bioconjugated vaccines, and multispecific antibodies. Sesay described his company’s capabilities, which span from preclinical process development through commercial supply. Currently, the Goodwin site in Fort Lauderdale, FL, is equipped for 200-L and 500-L bioreactors in both stainless-steel and single-use formats. The company can perform drug substance and drug product manufacturing as well as fill–finish steps, all according…

eBook: Speed to IND — Practical Wisdom for Uncertain Times

Even in “normal” times, companies need to balance time to filing an investigational new drug (IND) application against careful consideration of processes that can have far-reaching consequences on the quality of biologic products. But supply-chain interruptions still feature prominently in the news during the ongoing COVID-19 pandemic. From equipment to chemicals to plastic components, end users, their suppliers, and (critically) their suppliers’ suppliers all are feeling growing uncertainty about production timelines and availability of materials. In this eBook, BPI’s editor…

Preparing for Process Improvements: Discussions of the Cell Therapy Industry’s Supply Chain, Automation, and Control Needs

As editors, we are fortunate to have the opportunity to listen to biopharmaceutical developers and innovators discuss the intricacies of their work. Typically, we find that the best discussions come from asking two fundamental questions: What need did you observe in the industry that drove your work, and what technologies would help you do your job better? Over the past five years or so, the answers have shifted. Cell and gene therapy (CGT) innovators are focusing on increasingly complex diseases…

eBook: Buffers — Navigating New Demands on Downstream Raw Materials

Bioreactor titers for monoclonal antibody (MAb) processes have increased significantly since the dawn of the biopharmaceutical industry, yet such gains have instigated bottlenecks for critical high-volume raw materials used in downstream processing, such as buffer solutions. As downstream purification is required for most, if not all, biopharmaceutical products, buffers and their preparation are topics that concern nearly every drug company. But those topics rarely receive direct attention. This BPI eBook explores what factors prompted the current buffer bottleneck and what…

Don’t Be Forced to Accept a Bad Deal During the COVID-19 Crisis

Your boss’s boss just gave you the mandate to procure equipment, components, and raw materials for development and production of a new vaccine. Your goal is to get those as soon as possible — in addition to securing a massive volume for the future. You and your company are in the spotlight, and under significant pressure to deliver. You simply cannot fail. Yet many other players in your industry find themselves in the very same situation. Demand is exploding, and…

Evolving Business Models to Meet the Future of Healthcare

Yourway provides integrated supply-chain solutions for the global pharmaceutical and biotechnology industries. We exceed traditional offerings to provide customized support that includes warehousing and packaging, project management, planning and optimization guidance, comparator sourcing, ancillary-supply sourcing, forecasting, and returns/reconciliation management. Our single–specialized-provider approach offers clients a high level of convenience and efficiency that translates into quality, speed, and operational improvements. A Growing Global Footprint As we introduce new added-value solutions, expand our global footprint, and continue investing in infrastructure, technology, training,…