What’s The Environmental Impact Of Biopharma Continuous Manufacturing? Part I

One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.

Tuning Intermediate Volumes On Sepax™ C-Pro Cell Processing System

Discover how we automate the optimizing cell harvesting process and further minimize the potential for cell loss during wash steps.

CAPA System Best Practices For GMP Compliance

A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. This article delves into the pros and cons of autonomous and integrated systems, and shares some overall CAPA best practices. 

3 Strategies For Optimal Oversight Of Your Outsourcing Partner

Building strong relationships with chosen biopharma outsourcing partners, namely CDMOs and CROs, relies on a solid outsourcing framework. This article discusses three key areas that should be built into your outsourcing framework and agreements.

Bioprocessing Sees Continued Improvements In Batch Failure Reductions In 2022

Bioprocessing is generally doing better than ever in terms of minimizing batch failures. In BioPlan Associates’ 19th Annual Report and Survey on Biopharmaceutical Manufacturing Production and Capacity, we discovered the leading cause of batch failures and more insights.

2022 Outsourcing Trends In Biopharmaceutical Manufacturing

The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.

Assessing Extractables & Leachables In Parenteral Drug Products

Therapeutic complexity increases the potential risks associated with chemical composition of materials used for drug packaging. Leachables in drug or biological products are chemical compounds that originate from components that are used to store and deliver medicines. Extractables should be considered as potential leachables.

FDA Finds Drug Shortages Are Mostly Caused By Quality Issues

New FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages recommends an RMP for drugs that treat rare diseases and conditions, drugs with no alternatives, sole source products, products with only one API or manufacturing site available, and drugs made in facilities where an Official Action Indicated has been issued.

Biopharma In China: The Emerging Global Force Of Domestic Suppliers

Though multinational corporation vendors have seen double-digit pandemic-related sales increases for bioprocessing supplies in China, the top domestic vendors have posted even higher growth rates. With domestic supplier prices significantly cheaper, quite a few Chinese biopharma companies are shifting their purchase of supplies.

Biopharma Partnerships: 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.

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.