This whitepaper aims to promote an understanding of the analytical landscape for testing complex biological raw materials in ATMPs

RSSL Technical Expert Dan Nicolau considers the challenges of method development for nitrosamine analysis and the risk nitrosamines can pose

RSSL experts take an in-depth look at vegan product development including how to understand your market

RSSL experts take an in-depth look at vegan product manufacturing including the guidance surrounding vegan claims

A Sterility Expert's guide to the importance of disinfecting, how to select them and use the effectively.

A step by step look at the measures that can be implemented to minimise the risk of Covid-19 contamination in clean GMP facilities

Watch to learn about the difficulties associated with the sterility test method validation and practical approaches for dealing with more difficult products

This paper is designed to support for pharmacopeial monographs with an emphasis on products that are difficult to test or validate, offering a practical approach to sterility testing.

Food businesses now offering home delivery or takeaway services must be aware of the difference in allergen regulations applicable when food leaves the premises

Take a look at how our Pharmaceutical Contract Research Laboratories in Reading UK are providing high quality support through all drug product development stages.

Substantiating vegan and vegetarian claims can be challenging, join Nia Willis – DNA & Protein Laboratory Manager at RSSL as she discusses the analytical testing available to help substantiate claims

This white paper considers the relative risks, transmission vectors and guidance for working in cleanrooms when considering COVID-19

A novel selective technique for measuring nanoparticles

RSSL Senior Scientist Dan Nicolau talks through the method he and his team have developed to help manufacturers risk assess for Nitrosamine impurities

When a sterility test produces a positive result it demands both an examination of the laboratory test and the production process to determine why the test failure occurred

EU GMP Annex 1 is the primary document governing the manufacture, control and release of sterile pharmaceutical products.

This paper considers the practical application of environmental monitoring for both sterile and non-sterile products, together with best practice ideas.

This webinar provides an overview of the best practices in relation to environmental monitoring, providing microbiologists with a benchmark for their practices

Join our expert panel for a discussion about the role immunity will play in consumer choices in the food market in a post coronavirus world

RSSL’s Food Safety and Quality Consultants provide guidance for manufacturers and retailers when considering new suppliers

Find out how to approach the validation correctly, choose the right organisms and surfaces and the importance of the disinfection process

Join Dr Tim Sandle as he reviews the measures that must be taken after a sterility test failure, from immediate steps to preventative actions

Insights into the critical microbiological quality attributes required for the manufacture of sterile products, including bioburden and endotoxin control.

This webinar considers how consumer behaviour is driving ingredient trends and product development

This webinar will take you through key areas that need to be considered when turning your food innovation idea into a reality

This webinar will take you through the top level regulatory process around novel food identification

The success of your food product is dependent on it meeting the desired sensory, textural and structural properties and on using an efficient manufacturing process.

Which consumer trends are expected to drive food and drink innovation? And how will the industry respond? Here we bring you our predictions for 2020 and beyond.

More people than ever before are eating vegetarian and vegan products, resulting in significant market growth over recent years. This increased demand is driven by a combination of factors from perceived health benefits to environmental and ethical concerns.

Brian Hammond, Cleaning Validation, RSSL Consultant will speak about 'The importance of a plant inspection to a successful cleaning validation outcome' in this webinar.

Host cell DNA quantitation can be achieved either with non-specific fluorescent probes or by quantitative polymerase chain reaction (q-PCR). It is the latter specific quantitation method that we have qualified for the accurate and sensitive detection of host cell DNA from Escherichia coli and Chinese Hamster Ovary (CHO) cell lines.

The need to avoid the consumption of gluten by sufferers of coeliac disease has driven the food industry to implement rigorous labelling practices providing the tools for sufferers to limit gluten consumption. The Food and Drug Administration (FDA) has issued its guidance with regard to labelling within the pharmaceutical sector.

This white paper discusses the key difference between isolation and purification, and then focuses on an efficient strategy for method development, scale-up and post-isolation treatment. If outsourcing, this highlights the benefits in establishing a supplier who have the full breadth of expertise spanning across preparative chromatography and all supporting techniques.

This white paper discusses an approach to monitoring the levels of residual DNA derived from the production host for the drug including consideration of practical control of contamination as well as the MHRA’s guidance on performing PCR analysis

This white paper will provide an overview of residual solvent testing as per the United States (US) Pharmacopeia and the testing carried out at Reading Scientific Services Ltd (RSSL).

The success of your biopharmaceutical product is dependent on it meeting regulatory requirements for safety, efficacy and quality.

Identification and quantification of impurities as required in ICH Q6B and EMA Guidelines

Although there are a growing number of alternative ingredients for sugar, each must be evaluated in terms of its strengths, weaknesses and limitations in the required application. Here we review the options from a technical, regulatory and consumer perspective – and explain why understanding these dynamics is essential to finding the right solution.

View the range of biopharmaceutical services RSSL offers. From analytical testing to training and consultancy

This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.

Extractables and Leachables studies are required to understand the risk associated with pharmaceutical packaging systems.

There is an ongoing challenge to either exploit new ingredients or to use existing ingredients in new ways to create products that meet the change in demands of the market

This white paper gives an overview of the techniques that can be used to investigate foreign bodies, to limit the financial and reputational damage that a foreign body incident can engender.

There are many ingredients available but selecting the most appropriate solution for your product can be confusing and time consuming. This guide is designed to help you with the process of reducing sugar.

The objective of this study was to investigate the root cause of poor flow and caking observed in milled polyols during transport through pneumatic conveyers. Particle size, crystallinity, moisture uptake and flowability of milled sample that showed poor flow was compared with a milled sample (same material) from a different supplier that flowed well.

Discover the range of food and consumer goods services we offer including analysis, product development, consultancy and training

View the range of pharmaceutical and healthcare services RSSL offers. From analytical testing to training and consultancy

View the range of pharmaceutical training courses RSSL offers

Our flexible QP training programme consists of self-contained modules closely aligned to the knowledge requirements of the Joint Professional Bodies study guide.

Designed to help you keep up-to-date with the latest trends, GMP/GDP and Quality Hot Topics. Find out more.

View our pharmaceutical in-house training solutions.

This whitepaper discusses the formation and detection of nitrosamines. It also covers nitrochemiluminescence detectors.

Ensuring the identification, purity, safety and quality of your biopharmaceutical product.

From pre-clinical development through to finished product find out how RSSL can support you

Cleaning Validation, a GMP requirement, is key to the manufacturing process. Find out how RSSL can support you.

Delivering global analytical support for the rapid resolution of your food, drink and consumer product emergencies.

Delivering global analytical support for the rapid resolution of your medicinal products, raw materials and medical device emergencies

Overview of USP <661> changes RSSL can support you with

The effect of lowering the fat content and extending and modifying ingredients on the microstructure of lighter mayonnaises has ....

Aeration plays a key role in determining the structure and therefore sensory attributes of food products including bakery products, confectionery, mousses and puffed starch based snacks.

This poster demonstrates the capabilities of RSSL's Metals Laboratory.

This study investigates whether PTR-MS can be used to follow the development of volatile and odour active compounds throughout the baking process.

This white paper discusses the over-arching strategy for performing a successful cleaning validation, with detail on some of the key factors to consider at both the manufacturing and analytical stages, highlighting many common pitfalls to avoid.

Overview of method development strategy, validation and revalidation

The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle

This white paper highlights the benefits of this technique, including relatively straightforward sample preparation, data analysis and quantification.

Assessment of Extractables and Leachables is an essential part of drug product development and is a regulatory requirement to ensure patient safety

This white paper provides an overview on how the regulations have evolved through the pharmacopeias, how the ICH has impacted these regulations, how these could be implemented by manufacturers and the role of CROs in this process.

In this overview, a brief critique of some of the sample preparation techniques that can be used for ICP and AAS analysis have been given.

This white paper discusses using appropriate and validated methods to exploit the potential of functional ingredients

Throughout the whole of the cleaning validation process it is important that good records are maintained, both to satisfy the demands of regulators and auditors, but most especially to ensure that lessons are learned and kept within the business to be used to improve procedures.

This white paper discusses how to achieve a substantiated 'free-from' claim.

Problems arising from unexpected issues with raw materials (in this paper, we consider raw materials to be ingredients, as well as packaging and chemicals used on or around the process environment) can be much more difficult to identify and explain.

We assess GC-MS/MS as a tool to identify a number of the common tainting compounds found in the food and drinks and compare this to traditional GC-MS, to determine whether an increase in sensitivity can be seen, and in turn address an age old problem.

This white paper provides an overview of risk assessment and allergen management

Polymerase Chain Reaction method summary for the detection of allergens in food

The purpose of a spike recovery procedure which determines whether or not a particular sample matrix has any kind of effect on ELISA analysis.

Information on environment monitoring of allergens using swabbing procedure

Overview of animal speciation testing by DNA analysis: Real-time PCR and PCR/RFLP.

Guidance on choosing either qualitative or quantitative GM analysis

Overview of fish speciation in raw and processed foods using the latest DNA-based analytical techniques

Preparation of Pharmaceutical Samples for Metals Analysis including direct analysis, dissolution and closed vessel digestion

This white paper discusses some of the more common taints and off-flavors associated with raw materials, micro-organisms, processing, packaging and storage.

This white paper discusses the value of flavour analysis, sampling and choices of extraction techniques

This white paper discusses reformulation and processing options, oxidative stability, rapid techniques, and provides case study examples

Microscopic techniques provide an insight into what is occurring and enable the producer to control the process based on an understanding of these interactions.

This white paper provides an overview of sweetener options

Extractables and leachables studies are critical in maintaining the quality of a drug product and ensure that you meet all regulatory requirements.

This paper demonstrates how the use of microscopy techniques can be used to characterise, understand and monitor the stability of emulsions

The use of fluorophores or UV-absorbing chromophores to increase analytical sensitivity and specificity

The aim of this document is to review the available techniques to measure food aroma, especially focusing on the most innovative methodologies to measure aroma release during consumption.

This article focuses on the analytical approaches that must be considered when performing a method development and validation exercise to ensure that your test method is fit-for-purpose, and meets the regulatory need of your nutraceutical of interest

The EU Guidelines on the Good Distribution Practice of Medicinal Products for Human Use places significant new demands on the manufacturers and distributors of pharmaceutical products.

This video highlights important analytical tests that must be undertaken when setting specifications to meet ICHQ6B guidelines.

With new, stronger guidelines, more product types requiring QP certification is required than ever before, a shortage of suitable qualified and experienced QPs is the last thing the UK industry needs.

The focus of this paper will be drug delivery medical devices, which safely transport pharmaceutical therapeutic chemicals to target areas in the body.

This paper describes four orthogonal analytical techniques used to analyse monoclonal antibody PTMs with special emphasis on glycosylation.

This video highlights RSSL's allergen analysis service

Video showing the process involved in a taint investigation