Drug Substance

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How to appropriately classify your cleanroom at early-stage design

BioPhorum Drug Substance Closed Systems in Controlled Non-Classified Workstream has recently published its room classification model article in the July/August 2021 edition of the PDA (Parenteral Drug Association) journal.  The paper outlines an assessment process to assist biopharmaceutical companies in assigning an appropriate grade of cleanroom during the early stage of design (e.g., concept design phase) in drug substance manufacturing...

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The Russian Pharmacopeia: a reflection on the challenges to achieving greater alignment for biologics

The Russian Pharmacopeia: a reflection on the challenges to achieving greater alignment for biologics   The Russian Pharmacopeia oversees the quality of pharmaceutical products for the Russian market, but Russian authorities often have a stricter application of requirements compared to other countries. Also, when moving from national to regional (Eurasian Economic Union) standards, some Russian requirements are likely to remain...

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An industry reflection on the application of the Russian Pharmacopeia to the registration of biologics

In this paper, a BioPhorum member team of experts in biologics and vaccines have summarized the current challenges linked to the registration of global products in Russian Federation. This paper describes some of the challenges faced by the industry in relation to current pharmacopoeial requirements for biologics and vaccines and presents a framework of options and activities that would lead to greater alignment with the ICH and the expectations of other regulatory agencies.

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Supplier change notifications – bringing color to a grey area

Regulators require the biopharmaceutical industry to manage changes to raw materials in a compliant way – including those initiated by suppliers. A significant challenge is how to manage the large volume of supplier change notifications (SCNs) while ensuring a compliant and uninterrupted supply of materials for production. Companies often need to manage hundreds of raw material SCNs per year, potentially covering hundreds of materials from a...

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BioPhorum launch new sustainability phorum

BioPhorum members have given us a clear message; to be an industry that supports sustainability is extremely important to them. With no other single organization providing ‘one voice’ for the industry, discussions have been gathering pace to launch a dedicated sustainability phorum. This will become the prime vehicle to translate high-level corporate statements and commitments into practical, on-the-ground, scalable and transferable solutions....

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A guide to integrating CPV reporting and APR practices

Continued process verification (CPV) and annual product review (APR) practices are crucial for maintaining a state of control and identifying continuous improvement initiatives in the pharmaceutical and biological industries. Regulators also require both practices. However, while many companies have modeled their CPV reporting on the APR reporting process, the two practices are often not fully integrated, leading to inefficiencies. For example,...

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Raw Materials: Supplier change notifications: change areas and requirements

This guidance document identifies the relevant change areas, and for each area, exemplifies the type of changes which the biopharmaceutical industry needs to be informed about. It also lists the required information, in terms of supporting data and documentation, to support notification of changes. This guidance is relevant to all raw materials used to produce biopharmaceutical products, including but not limited to cell culture media, fermentation broth components, column resin, buffers, solvents, and excipients. By highlighting the changes biopharmaceutical industry end-users need to know about and specifying the information required, the intention of this industry-aligned guidance is to reduce the quantity of rework required and the time taken to process change requests. In turn, this will reduce variability in demand patterns as end-users refrain from building extensive inventories to mitigate against the perceived risks which arise from proposed changes. While complete alignment and standardization on the information which should be provided for changes is not possible, a more robust alignment on the typical information required, as set on in this guidance, will significantly improve the current state.

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Deviation Management (DMS): Guide to implementing a risk based deviation management system

BioPhorum has developed a risk-based deviation management system (DMS). 13 member companies have implemented this approach, and summary data from these companies shows improved quality performance plus an average time saving of 22,200 work hours per site per year, which is equivalent to a $888k cost saving.

This guide outlines the work of the BioPhorum DMS Workstream in defining and creating a simplified and effective risk-based deviation management system with advanced RCA methodologies, and a track-and-trending process of low-risk events. It includes everything required to build a risk-based approach to DMS, including the business case for change, the new process, risk-based tools, and a detailed sharing of post-implementation benefit.

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BioPhorum strengthens supply chain resilience through digitization of the supply chain and alternatives to gamma sterilization

Since 2016, BioPhorum Supply Partner has made great progress in bringing together manufacturers and supply partners to build modern and effective inbound supply chains and develop a program of work that addresses some key areas: risk; planning; and education, qualification and control. Its industry expertise and ‘horizon scanning’ mean its transformative program reduces risk and adds value for members. This can be seen in the creation of two...

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Shared clean-in-place systems: to share or not to share

This paper discusses design challenges such as how biomanufacturers often use extreme measures to segregate a post-nanofiltration operation from a cell-culture operation – but use a common glass washer or clean-in-place (CIP) skid for cleaning and sanitizing components from the two operations. The article looks at this apparent contradiction by using a mathematical model to evaluate the potential carryover/crossover risk.It aims to simplify production facilities so that a manufacturer doesn’t have multiple systems performing the same task. This means lower costs and complexity and facilities that are quicker to build and operate.

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