Drug Substance


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How to understand and mitigate the problem of trace element variation

A reliable supply of life-saving drugs requires understanding and mitigating any variability to support consistent supplies. However, the crucial timelines for making a drug product available to patients can be heavily impacted when variability is introduced through raw materials such as cell culture media (CCM) and reagents. Investigating a failure in production is costly and time-consuming and can delay product supply to the market – so a...

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Trace element variation for chemically defined cell culture media: biopharmaceutical industry requirements and cross-company collaboration to mitigate risks

A proactive risk-based approach to understanding key factors that can introduce product variability is necessary to avoid delays. One such factor identified is elemental impurity variability introduced by cell culture media. Though the impact of the variability will differ, it is important
that both manufacturers and supply partners understand the sources of elemental impurities and perform risk assessments to identify mitigation strategies. Such assessments will allow an understanding of the level of risk, and what steps may be taken to dissipate it. This paper is an effort to drive regulatory bodies, drug manufacturers, supply partners and N-1 suppliers toward a common understanding of the problem and possible solutions that can be taken towards risk mitigation. Though there may not be a single or ideal solution for this issue, a common rational approach can be taken by all parties to understand the impact on their processes and products, to drive identification of mitigation strategies.

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The four steps for registering innovative and complex raw materials

The Covid-19 pandemic has put extra strain on an already stretched biopharmaceutical supply chain. As industry has grown exponentially over the last couple of years, there has been an increased demand for materials and many existing products share these with the new Covid-19 vaccines, testing kits and therapies. As a result, these materials have been diverted to this high-priority use.  The pandemic has therefore demonstrated that reliance...

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How to replenish working cell banks with a risk-based scientific approach

Cell banks represent the fundamental starting substrates for biological drug substance/drug substance intermediate manufacturing. So, the availability of well-characterized cell banks capable of supporting manufacturing processes is critical for an uninterrupted drug product supply to patients and global markets.  This is why two-tier cell banking systems are developed, consisting of master cell banks and...

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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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