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PHORUM

Drug Substance

Overview

Drug Substance (DS) aims to accelerate the way our operations deliver near-term results. The program is informed increasingly by the Technology Roadmap as well as members’ immediate needs to improve manufacturers’ licenses to operate. Teams here have led the drive to make single-use technologies as easy to specify and implement as stainless steel, and continue to help members to realize step changes in microbial control, quality management systems, and the use of closed systems; as well as pushing back the barriers on post-approvals submissions with a growing number of authorities.

The DS Phorum enables biomanufacturers to collaborate on their most challenging operational strategies.

DS addresses strategies that cannot be achieved in isolation, but require a critical mass of users to define common requirements for suppliers or to align on interpretations of regulatory requirements.

This is achieved by collaborating with each other, supplier partners and health agencies to define manufacturer requirements and best practices which are then used to implement modern biopharmaceutical supply chains.

Benefits include:

  • Implementing a risk-based Deviation Management System, releasing up to 12,000 hours per annum for a typical site and so enabling improved investigation and CAPA effectiveness
  • Reduced risk to License to Operate by addressing subjects of microbial control concern to regulators in the form of best practice protocols
  • Introducing type tested valve diaphragms which reduce changeout frequency from 6 to 24 months, delivering 30% increase in asset utilization, saving ~ 40% engineering labor and use of ~ 50% fewer seals
  • Drawing upon standard supplier extractables data defined by the BioPhorum protocol and instituting a risk-based approach to leachables testing, thus reducing significant effort and lead time
  • Introducing a standard and optimized shipping validation best practice process and so securing $500,000 -$1.0 million annual savings and reducing validation timelines by 6-12 months
  • Implementing a harmonized risk-based approach to single-use change notifications, thus lowering risk to licence by defining appropriate notification periods with the supply base
  • Delivering industry alignment on internal release testing requirements for single use system (SUS) materials

News

Feb 2019

Articles

Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the[..]

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Dec 2018

Articles

2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you[..]

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Oct 2018

Articles

Why leaders should go to where work is performed to learn about success, failure and risk

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Sep 2018

Articles

Decision tree to improve single-use change notification classification

The BioPhorum/BPSA change notification team have made the paper “A guide to the classification of changes to single-use biomanufacturing systems” available here.

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Sep 2018

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Member companies’ senior sponsors make a statement on co-implementation

BioPhorum Drug Substance (DS) member companies recognize the importance of visible senior sponsorship when it comes to workstreams that require co-implementation in[..]

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Jun 2018

Articles

New toolkit to accelerate single-use design and specification

The single-use user requirements toolkit is now live and available for free download on the BioPhorum website  The toolkit streamlines the design[..]

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May 2018

Articles

How to reduce bioburdens in the affinity capture process

The Microbial Control workstream has addressed the microbial risks and controls associated with affinity capture chromatography, a standard step for bioprocessing. They[..]

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Apr 2018

Articles

Lean Qualification and Validation team aim for waste reduction

The Lean Qualification and Validation (LQV) Workstream group was graciously hosted at the GlaxoSmithKline headquarters in Brentford, UK this past March to[..]

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Apr 2018

Articles

CPV portal now live

We have published our resource portal for Continued Process Verification (CPV&I) following the publication of the Legacy Products guidance document at the[..]

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Mar 2018

Articles

BioPhorum work with Anvisa to reduce approval times by up to one year

BioPhorum is working together with Brazil’s Anvisa to help increase the rate at which approvals are made by up a year.

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Mar 2018

Articles

Up to 50 per cent cost reduction from CNC environment use

Over the last three years BPOG has entered into a collaboration with the Biomanufacturing Training and Education Center (BTEC) at NC State[..]

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Nov 2017

Articles

Insights into the Closed Systems workstreams BTEC sanitization studies – Video Interview with Dr Kavita Ramalingam Iyer

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Nov 2017

Articles

Continued Process Verification delivering real saving in time and money

More than 50 per cent of biopharma products on the market now have Continued Process Verification (CPV) plans in place.  Thanks to[..]

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Oct 2017

Articles

Mold Guidance Paper aims to reduce events and save costs

Mold will never be a glamorous subject but it is one which impacts every member company and the prevalence of mold events[..]

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Sep 2017

Articles

Focusing Deviation Management on the big wins

Current methodologies which conduct check-the-box “investigations” for every minor deviation, can lead to companies unintentionally instilling an over reliance on basic tools[..]

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Jun 2017

Articles

Companies start work on 505 Pathway

A change in FDA regulations, associated with classification of proteins, prompted several companies to ask BPOG to facilitate a collaboration to help[..]

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Jun 2017

Articles

Industry proposal for change notification in single use systems

A BPOG and the BioProcess Systems Alliance (BPSA) workstream comprising contributors from 17 drug manufacturers and 12 suppliers has been working on[..]

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Jun 2017

Articles

Increase production capacity by optimizing maintenance frequencies

The Drug Substance (DS) reliability workstream has developed guidance enabling member companies to optimize their maintenance and calibration frequencies by assigning the[..]

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Jun 2017

Articles

Storage & Transport set out plan to harmonize shipping practices

The Storage and Transport workstream are setting out ways to standardize the validation of shipping lanes and equipment across the industry. Working[..]

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Jun 2017

Articles

Contamination Event Free Production Process by 2022

For three years the microbial team has worked to address significant challenges in the areas of quality, risk, and cost - all[..]

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Mar 2017

Articles

BioPhorum produces landmark best practices guide for evaluating leachables risk

BPOG’s Leachables team has just published an Industry Best Practice Guide: Best practices guide for evaluating leachables risk from polymeric single-use systems[..]

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Feb 2017

Articles

BPOG in the Press

The BPOG workstreams have gained a lot of coverage in the industry press in recent months with topics ranging from Technology Roadmapping[..]

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Feb 2017

Articles

The Role Of Human Performance Tools & Just Culture In Biopharma Operations

An article written by Brad Rank, Bayer, and representative of the Human Performance workstream has been picked up by three online publications.[..]

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Dec 2016

Articles

Companies Consider Ways to Make Investigations More Effective

BPOG members are now considering the recommendations of a report made available internally in May 2016, to improve the efficacy of their[..]

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Nov 2016

Articles

Study shows new cleaning methods obtain functional closure in CNC areas shared with industry

Over the last two years BPOG has entered into a collaboration with the Biomanufacturing Training and Education Center (BTEC) at the University[..]

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Oct 2016

Articles

Governance and ROI set the focus for BPOG 27

Focusing on governance and return on investment (ROI), together with an enhanced method of program design ensured that the Drug Substance (DS)[..]

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Oct 2016

Articles

BPOG Team pilots PAS strategy with Brazil

Drug manufacturing including method changes and adding new sites for drug substance or drug product have to be dealt with on a[..]

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Sep 2016

Articles

Developing a Best Practice Guide for Leachables Risk Assessment

Kathryn McGohan (Scientist, BMS) writes in an article, which first appeared in Biopharm Asia, about the development of a best practice guide[..]

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Jun 2016

Articles

Busy Quarter for Drug Substance

Drug Substance has just completed an intensive period of face-to-face events where the workstreams have formulated plans for the next cycle of[..]

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Jun 2016

Articles

Human Performance Continues Growth Within BPOG Member Companies

Human Performance team were hosted by Amgen at their Puerto Rico facility for the sixth face-to-face meeting on 31 May - 2[..]

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Jun 2016

Articles

‘Patient-Centric Requirements for the Supply of Raw Materials’ white paper published

The Raw Material Variability workstream have just launched their white paper 'Patient-Centric Requirements for the Supply of Raw Materials into Biopharmaceutical Manufacturing'.[..]

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Jun 2016

Articles

BPOG Members get their message out

The BPOG workstreams have been active recently in getting the fruits of their collaborations reported in the biopharmaceutical press. From April until[..]

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Jun 2016

Articles

A roadmap for the implementation of continued process verification

This article provides a roadmap draws on the content of the CPV case study to provide a step-by-step guide in a more[..]

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Jun 2016

Drug Substance News

PATIENT-CENTRIC REQUIREMENTS FOR THE SUPPLY OF RAW MATERIALS INTO BIOPHARMACEUTICAL MANUFACTURING

Raw material variability and control of the supply chain are important issues for the biopharmaceutical industry. The industry is still at an[..]

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Apr 2016

Articles

Creating consistency in Single Use, User Requirements

As single use equipment becomes ever more mainstream in our commercial operations, more qualification questions are being asked by both us and[..]

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Apr 2016

Articles

Closed Systems prepare to tackle ‘Viral Segregation’

The Closed Systems in CNC team is intending to start work on the new sub-topic of 'Viral Segregation' at the end of[..]

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Apr 2016

Articles

New website resource for Extractables Protocol

BioPhorum has launched a special area on our website for the BPOG Standard Extractable Protocol this month. It is designed to be[..]

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Feb 2016

Articles

Novartis Rejoin BPOG

After a three year hiatus Novartis have rejoined BPOG Drug Substance. The biologics leadership team is currently reviewing where are how they[..]

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Feb 2016

Articles

‘Breaking the Mould’: Helping Operators to Add Value

The term 'paradigm shift' has become something of a cliche in recent years, but the work of the Operator Competence (OC) team[..]

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Dec 2015

Articles

Transport and Implementation the focus for BPOG Drug Substance in 2016

Following the BPOG24 meeting in October 2015, the final adjustments have now been made to the Drug Substance program for 2016. Next[..]

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Dec 2015

Articles

HuP Changing the Performance Paradigm in Biogen and Lonza

Errors are a fact of life. In a pharmaceutical context, errors impact safety and quality, and potentially supply. With around half of[..]

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Dec 2015

Articles

Technology Transfer Best Practices Published

BPOG's Tech Transfer workstream has been working hard to develop common definitions and standardize the language used in Tech Transfer to make[..]

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Nov 2015

Articles

Suppliers and End Users Working Together to Improve Change Notification

Alterations to materials, manufacturing process changes, and production locations in the supply chain can all have a significant impact on a biopharma[..]

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Jun 2015

Articles

Standardized Extractables Testing Advances Single Use Adoption

BPOG's work on the Standard Extractables Protocol is highlighted in a recent article by Trisha Gladd, Editor in Chief, Bioprocess Online

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Oct 2014

Articles

Continued Process Verification for Biopharma Manufacturing

The authors discuss complications of implementing continued process verification and provide recommended approaches.

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Sep 2014

Articles

Process, People, Perfection: Learning from the Pioneers in Human Performance

Today, in 2014, more than 50% of deviations in the biopharmaceutical industry are the result of human error. The highly regulated, advanced[..]

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Sep 2014

Articles

Optimizing Human Performance, Part III

This article is the third and final in a series designed to offer leaders and managers at all levels in the industry[..]

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Aug 2014

Articles

Raw Materials

Biopharmaceutical Manufacturers are developing a new approach to controlling variability in raw materials

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Jul 2014

Articles

BioPhorum ‘CPV’ collaboration tackles regulator guidance

BioPhorum has today published a Continued Process Verification (CPV) Case Study to help members of the biopharmaceutical industry implement high quality, consistent[..]

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Jul 2014

Articles

Road Map to Human Performance Excellence

In the first article in the series - OPTIMISING HUMAN PERFORMANCE - Part One, the author explains how companies can prevent human[..]

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Jul 2014

Articles

Optimizing Human Performance, Part II

Part II of this three-part series presents a roadmap to human error prevention.

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Jul 2014

Articles

Optimizing Human Performance, Part I

Achieving excellence in human performance is an achievable system of cultivating and sustaining exceptional levels of performance.

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Jun 2014

Articles

Reducing Human Error

Leading industry collaborators outline top 10 best practices for human error reduction.

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Nov 2013

Articles

Facility Efficiency – Regulatory, GMP Challenges

Closed Systems in CNC Ballroom Design

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Nov 2013

Articles

Supplier-Change Management for Drug-Product Manufacturers

Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an[..]

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Aug 2011

Articles

Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug Substances

The control of the environment around biologics manufacturing has historically been a key consideration for the design and operation of bioprocessing facilities[..]

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Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

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