Host cell protein (HCP) : Benchmarking mass spectrometry standards for USP

11 March 2019
Development Group
Host cell protein (HCP) : Benchmarking mass spectrometry standards for USP

BioPhorum and United States Pharmacopeia (USP) share a common direction – to accelerate biopharma innovation, quality and progress through collaboration.

To this end, USP engages with industry to understand its pain points, its challenges and where there is the potential for new standards.  Diane McCarthy, Senior Manager, Science & Standards-Global Biologics at USP stated that they have been looking at what additional standards we can develop that aren’t necessarily the traditional USP product-specific standards, but that would be helpful to the biologics industry more globally. These would go across a particular product class or even multiple product classes and are tentatively being called ‘performance standards.

This is where BioPhorum is playing a major role. The organizations are working together on the following two biopharma areas in which there are currently no USP standards. Benchmarking surveys into these areas are being used to gain the industry consensus that is crucial to the successful development and use of new standards.

Host cell proteins

Proteins originating from the host cell during recombinant production can affect drug safety and efficacy if they are not reduced in downstream production. Recent USP roundtables have highlighted the need for standards and tools to identify and quantify host cell proteins (HCPs) using mass spectrometry  USP has asked for help to refine the potential uses, formats and types of HCP standards for mass spectrometry, which will make it much easier for industry to detect and identify certain HCPs. These standards will improve efficiency, time and costs as companies will not need to develop their own standards.

To aid the development of new USP standards in this area, the Development Group surveyed its members to identify problematic and prolific HCPs and their use. USP is now using this survey feedback to inform its plans to create HCP standards for mass spectrometry.

This document is reserved for the use of BioPhorum members only.

My company would like to become a member

If you would like to enquire on behalf of your company about becoming a member, please see our membership page.

Microscopic Bacteria
Collaborating with USP on its Bacterial Endotoxin Test Protocol and Bioreactivity Draft Monographs

Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.


BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.


Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.


Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

An industry perspective on understanding AAV capsid content variants
Needle On Yellow Background
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
The Drug Substance 2.0 Strategic Value Framework
Coloured dots on teal, next to vial
BioPhorum’s holistic approach to container closure integrity
Magnifying glass over a tablet all coloured blue
Digital Plant Maturity Model 3.0
Investigation Digital Workstreams
Peer to peer practical guidance on remote inspections and audits
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
BioPhorum roundals on sugical gloves
A visionary strategic framework for future patient-centric outbound biopharmaceutical supply chains
DNA and Earth on blue background
A vision for the biopharmaceutical industry’s inbound supply chain
Lightbulb And Icons On Colourful Background
BioPhorum environmental sustainability roadmap 2022
Technology Roadmap V 2.0
BioPhorum Technology Roadmapping roadmap vision 2.0


Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.


Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.


BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.


A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

Browse all

Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

Bioreactivity testing in single-use system biomanufacturing
Bioreactivity testing in single-use system biomanufacturing
Bioreactivity testing in single-use system biomanufacturing
Magnifying glass over a tablet all coloured blue
Digital Plant Maturity Model 3.0
Bioreactivity testing in single-use system biomanufacturing