Validation... 3 questions to Yann RENOUARD*, Validation and Metrology Manager
What is validation?Validation is one of the important steps to present a case to the health authorities. Validation allows, with supporting documents, to demonstrate that a method or an analytical method reproducibly leads to the expected results.
According to GMPs: it is a "documented program that provides a high degree of assurance that a specific process, method or system will consistently provide a result that meets predetermined acceptance criteria".
What is it used for?Validation is used to demonstrate the control of critical aspects of a new process or to demonstrate that significant changes in plant, equipment or process have no impact on the quality of a product. These critical aspects of a new process are defined when performing a risk analysis.
What does Bio Elpida offer in this context?Bio-Elpida can help you carry out your validations, write the protocols, carry out the operations and save the corresponding reports by following the applicable references (ICH, PE or USP) thanks to a multidisciplinary team.
Bio-Elpida also conducts:
* Yann RENOUARD served as Quality Control Manager in ABBOTT and GSK laboratories. He was also a Process Validation Consultant for SANOFI PASTEUR. Yann RENOUARD joined Bio Elpida in September 2015.
Biotechnologies... A 100% single use based French start-up
From INDUSTRIE Pharma #102
A 100% single-use production line. This is the choice made for both, procaryote and eukaryote, by the French CMO start-up Bio Elpida.
"We produce banks, bacterial extracts, biomass, mastercell banks, cell banks in GMP conditions, cellular material for injection as well as autologous anti-cancer vaccines" says Éric Garcia, Head of Business Development. Since its inception, the company has decided to base its development on single-use technology, a choice that naturally impose itself due to the activity of the company in cellular therapies.
"Control of cross-contamination is required for cell therapies and we have very precious patient samples for which we cannot afford contamination" says Eric Garcia. A reduced risk with regard to…
Read more on INDUSTRIE Pharma website…
Potency Assay... 3 questions to Claude GAILLARD*, Quality Control Manager
What is a Potency Assay?It is a control method that uses a biological test to analyse the response of a defined dose of a product. The test provides an answer relating to the functional activity of the product or the drug being tested. These tests can includes techniques such as flow cytometry or ELISA.
What is it used for?A Potenty Test is of course essential to validate the quality of a product. This is especially true in biology in which variability is present whatever project. It also enables to carry stability studies that are essential during the initial phases of a clinical trials.
Potenty Test is one of the mainstay of the validations of production batches.
What does Bio Elpida offer in this context?We can have an hand on very early stages, with proposals for innovative in vitro tests meeting the specific quality objectives of a manufactured product. We can also develop tests or, if they exist, transfer technologies until validation of the methods.
This broad range of intervention is possible at Bio Elpida thanks to the multidisciplinary skills of the Quality Control team. It is these skills that enables us to adapt to customer needs and to the development stage of a project.
* After 15 years at the Schering-Plough Immunological Research Laboratory, Mrs. Gaillard then took positions in Quality Control, especially at Génopoïétic Laboratory. She joined Bio Elpida when the company was founded, in 2009.
Fill & finish... 3 questions to Benoît PECH, Production Manager
What are the possible fill & finish methods?We propose three types of fill finish:
What are the possible aseptic fill & finish conditions for Bio Elpida?We have two environments, located in two distinct and independent Clean Rooms. The first one for the filling of finished product, is a 120 m² environment classified A in B (equivalent ISO 7) according to the GMP. The second one is used for the filling of active substance. It is a 70 m² environment classified A in C. We also have a level D working area that we use to manufacture the culture media used in the various productions or of non-sterile product.
Why a method rather than another?Our methods of aseptic fill & finish are adapted to experimental drugs that are often "precious" and very expensive to produce. We can distribute volumes ranging from 50 μL up to several liters, while reducing to its maximum dead volumes. The range of primary containers used varies a lot: glass or plastic bottles, ready-to-fill AT-Closed Vial® bottles, bags, syringes, etc.
A major asset of Bio Elpida is the flexibility of the solutions we can provide to our customers. It is also the close relationship we have that enables us to fulfill their requests. This diversity and these challenges are also a real source of motivation for our teams.
2017, the confirmation!Nominated best biotechnology start-up of 2016 (Ernst & Young Award), the entire team of Bio Elpida is now turning towards the new year with the implementation of new collaborations in production and the development of new analytical methods for its current and future customers.
Our production and quality control units are already working for preclinical, phase I and phase II trials. They are now working for our partner customers on new oncology projects that should soon enter phase III trial.
In addition, our R&D unit implements new manufacturing and analysis techniques, particularly in the field of bacterial counting in collaboration with the Beckman Coulter teams and in the field of aseptic filling with Aseptic Technologies method.
We would be happy to welcome you and show you these new technologies.
The entire team and our partners are wishing you complete success in all your projects for 2017!
Immodulon Therapeutics Ltd. announced that in IMAGE 1, a randomised controlled Phase II clinical trial, IMM-101 (a bacterially derived systemic immunomodulator administered intradermally) in combination with gemcitabine, was associated with consistent and significant improvements in overall survival (OS) and progression free survival (PFS) in advanced pancreatic cancer patients.
IMM-101, used as an adjunctive immunotherapy, is a heat-killed whole cell preparation of Mycobacterium obuense prepared by Bio Elpida.
Download Immodulon Therapeutics Ltd.'s press release
Download the ASCO's Gastrointestinal Cancers Annual Symposium abstract
Bio Elpida, supported by the city of Saint-Priest - represented by its Mayor, Gilles Gascon - representatives of the LYON BIOPÔLE, of the city of Saint-Priest, of the CCI of Lyon, of the Grand Lyon, and also the DIRECCTE Rhône-Alpes joined the media at the official opening of Bio Elpida's new laboratory facilities: a 1,000 m² facility dedicated to the development of new innovative treatments based on cell therapy and immunological research.
"Our role is that of a facilitator, a gateway between the world of research and the pharmaceutical industry. We start with the concept that has been provided to us by the medical scientists and we shape it until it becomes an effective medication; safe, reproducible and accessible to the majority of patients" explained Benoît Pinteur, co-founder and CEO of Bio Elpida.
"We are proud that for two long-term clients dealing with brain and pancreatic cancers, we have already produced clinical batches for phase II in Europe and the USA. We are preparing for production of a clinical batch for phase III in 2015" stressed Gilles Devillers, co-founder of Bio Elpida.
Download the press release