BPI White Papers

Octet® Bio-Layer Interferometry Systems: Advancing Development of Coronavirus Vaccine and Therapeutics

Development of vaccines and therapeutics to target outbreaks of infectious diseases such as SARS-CoV-2 requires speed and agility. An essential part of this rapid response are technologies designed to streamline and accelerate workflows while delivering high quality data for informed decision-making. This compendium of applications demonstrates the use of the Octet® label-free platform utilizing bio-layer interferometry (BLI) technology to advance development of coronavirus vaccine and therapeutics. The fluidic-free approach offers important advantages over microfluidics-based technologies such as surface plasmon resonance…

Strategies for Successful Formulation Development of Lipid-Based RNA Delivery and Vaccines

Nucleic acid therapy using RNA and DNA as the active pharmaceutical ingredient (API) has the potential to cause a paradigm shift in the way diseases are addressed. This innovative therapy targets the source of the disease at the genetic level and can be used to modulate the expression of one or more proteins simultaneously – a unique advantage over conventional biologics or small molecules. Given this mode of action, RNA and DNA therapeutics are a powerful means to treat, and…

Shaping the Future of Formulation Development with Melt-based 3D Printing Technologies

Three-dimensional (3D) printing is a powerful technology that has wide-ranging applications, including many in the pharmaceutical industry. Among the approaches that are being explored in the production of pharmaceutical dosage forms powder-based systems which utilize either drop-on-powder or selective laser sintering and liquid-based systems which use drop-on-drop deposition or stereolithography are frequently applied. With liquid-based technology, either UV, laser energy or high temperature is used to induce polymerization and build the 3D structure. The process of 3D printing offers the…

Can CDMOs Provide Leadership in Cell and Gene Therapy?

Cell and gene therapies are poised to usher in a new era of healthcare. As of June 2021, 14 cell and gene therapies have been approved for clinical application in the United States, and over 400 more are in various stages of clinical trials. The hopes of many patients hinge on the success of these various programs, which are designed to deliver a significant advance on existing treatments or even a functional cure. As new cell and gene therapies get…

Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates

The pipeline for antibody–drug conjugates (ADCs) includes hundreds of candidates, with several expected to receive approval in the near future. As more commercial products reach the market, there is an acute need for CDMOs that understand how to execute late-stage studies to support a filing strategy. CDMOs with plans to support commercial-scale ADC manufacturing are setting up processes to handle challenging supply chains and investing in facilities and processes to ensure efficiency, quality and security. In this white paper, we…

Autologous CAR T Cell Manufacturing Using a Semiautomatic, Closed, Modular Workflow

Cell-based chimeric antigen receptor (CAR) T cell therapies have rapidly advanced in recent years, with a variety of targets in clinical research and several FDA approved products already on the market. There has been tremendous effort to make CAR T cells more effective, safe, and persistent when treating patients. On the manufacturing side, however, errors, lot-to-lot variation, and contamination can be associated with open processes and manual handling of CAR T cells. Cell isolation, gene editing, expansion, and cryopreservation are…

Edata Exchange – Embark On Your Digital Transformation Journey

You need the right data at the right time from your supplier to make important production and supply chain decisions to achieve your Biopharma Manufacturing goals. Now you have the eMERGE™ Program, our standard platform for the exchange of electronic data. It provides key raw material data, electronically, for every shipment, so you can start making informed decisions right away.

Vero Cell-based Vaccine Production: Cell lines, Media and Bioreactor Options

The recent Covid-19 pandemic introduced new challenges for the vaccine industry, it has also brought in new innovations in vaccine development including DNA/RNA based vaccines. The pandemic also increased the demand for well-established cell-based vaccine production technologies. The article reviews strategies for optimizing Vero cell-based vaccine production using rabies and influenza as examples. The Vero cell line is one of the most satisfactory vaccine production hosts based on its infectability, stability and well-documented performance in quality and quantity of viral…

Improving the Bioavailability of Challenging APIs using Hot Melt Extrusion with Polyvinyl Alcohol

New molecular entities (NMEs) are becoming larger, more crystalline and more lipophilic and, as a result, less soluble. While approximately 40% of active pharmaceutical ingredients (APIs) currently on the market show poor solubility, it is estimated that between 60 and 90% of compounds in development have solubility challenges.1,2 For an oral formulation, API solubility and permeability are critical factors for absorption in the gastrointestinal tract. As a result of this, solubility-enhancing formulation techniques have become an area of focus for…

Evaluating Current Manufacturing Platforms for Viral Vector Production to Enable Gene Therapy Products

The rapidly growing interest in gene therapy has led to the need for more cost-effective and scalable viral vector manufacturing platforms to deliver these therapies. Adeno-associated virus (AAV) has become the vector of choice as it stands out for its safety profile since infection with the vector is not pathogenic. Also, AAV cannot replicate on its own and is not directly integrated into the host genome. Realizing the full potential of viral vector-based therapies requires a successful manufacturing platform for…