Biopharma Partnerships: The Key To Filling The Life Sciences Innovation Gap

The life sciences industry is facing a significant slowdown due to patent expirations. Many organizations have not established a robust enough pipeline to overcome the revenue to be lost. To bridge this innovation gap, pharma CEOs will need to expand their use of alliances, in tandem with bolt-on M&A, as a pipeline booster strategy.

Key Considerations For Decarbonizing Your Biotech Facility

Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.

Demonstrating ROI For Increased Digital Plant Maturity

Cytiva has partnered with the independent software company, Biopharm Services (BPS), to model the costs and associated benefits of increasing digital maturity for monoclonal antibody processes in a biopharma plant utilizing single-use technology.

Liposomal And Nanoparticle Technology At Pfizer Melbourne

Specializing in oncology, anti-infective and complex formulations, the facility provides end-to-end services from development through to commercial manufacture of sterile dosage forms.

The Single-use Bioprocessing Bottleneck & Looking Ahead

Are you asking, What happened to the bags promised for my product? The single-use system bag market had been seeing strains as early as 2018, and COVID-19 made the demand worse. This article looks into the factors contributing to the demand. Normalization of the supply chain may continue to be delayed, but it will eventually even out.

Optimizing Feed Strategies: A Scalable Process

We present an optimized feeding strategy and demonstrate how a new, easy-to-hydrate, single-part, pH neutral feed can support optimal cell growth and high productivity of CHO cell lines.

Chemically Defined Cloning Medium For Quality, Regulatory Risk Mitigation

We review the performance and stability of a novel, chemically defined cloning medium that accelerates clone isolation, reduces the risk of variability in protein quality, and reduces impurities.

Quantitation Of Retrovirus-Like Particles (RVLPs) In CHO Derived Products

Review key methods which are applied to ensure safety of such recombinant proteins, with a focus on alternate and superior methods to the standard transmission electron microscopy (TEM) method.

A Multi-Scale Approach To CHO Media Benchmarking

In this study we apply a multi-scale approach to efficiently screen combinations of chemically defined commercial media and various CHO production clones using benchtop bioreactor systems.

Factory/Site Acceptance Testing & Commissioning Responsibilities

Execution of factory acceptance testing (FAT) and site acceptance testing (SAT) is a business-critical activity when it comes to commissioning of a new system or equipment. FAT is conducted at the equipment manufacturer’s site and SAT is conducted at the final site of installation. This article shares best practices.

High-Throughput mAb Purification With Fibro Chromatography

Rapid cycling, using Fibro PrismA units together with an ÄKTA pure™ system and an autosampler, offers new opportunities in high-throughput purification for screening of lead candidates and process conditions.

Strategies For Clarifying Harvest Feed Streams In Viral Vector Bioprocessing

The goal of clarification is to prepare the cell culture feed stream for downstream chromatography and purification. In this poster, we explore data driven strategies for clarifying harvest feed streams.

Facilities Remediation, Renovation & Reconstruction: When Does It End?

We sit at the beginning of 2022 amid the industry’s frantic and hurried effort to acquire, expand, and prepare more aseptic plant capacity — and to make it useable, compliant, and productive. This article provides a deep-dive on planning and design for your project, including walls, floors, ceilings, interstitial and mechanical spaces.

White Paper: Process Analytical Technology (PAT) Using Next Generation Raman For Real-Time Bioprocess Monitoring

In this white paper, we describe applications and share case studies using Raman technology for real-time, inline monitoring of cell culture process parameters.

FDA Proposes Inspection Of Injectable Products For Visible Particulates

FDA and CDER have released a draft guidance addressing the development and implementation of a holistic, risk-based approach to visible particulate control incorporating product development, manufacturing controls, visual inspection, particulate identification, investigation, and corrective actions. The public comment period ends Feb. 15, 2022.