News and events from Bio Elpida
If confidentiality is paramount, we can sometime share some milestones

November 2017

Bio Elpida in the media thanks to its single-use strategy

From Actulabo - November 2017 Supplement
Single use is on the front line

Pharmaceutical companies are increasingly using single-use to prevent contamination. While not being the ultimate weapon, single-use is certainly, when properly used and integrated into an uncompromising approach, one of the best lines of defense against contaminants.

Is single-use the alpha and omega of the fight against contaminants? For some operators, the case is settled. For example, for the Lyon-based CDMO Bio Elpida, which subcontracts the development of preclinical and clinical batches for cell therapy products and biopharmaceuticals, "the concept of single-use has imposed itself. Some of our clients work with patient biopsies and these samples represent a valuable health and economic asset. It is from these samples that they will develop vaccines. In this case, they do not have the opportunity to do it twice. Bio Elpida prefers to put itself in conditions where the risk of contamination is zero or almost", as analyses Éric Garcia, head of business development and marketing.

Read more on Actulabo website…


September 2017

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:
  • Equipment qualifications (IQ, OQ, PQ) according to Annex 15 of the GMP and USP (1058),
  • Analytical validations according to ICH Q2 and USP (1025),
  • And process validations according to Annex 15 of the GMP.
In addition, Bio-Elpida can also support you in the realization of your risk analyzes.

* 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.




May 2017

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…


April 2017

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.


February 2017

Fill & finish...  3 questions to Benoît PECH, Production Manager

What are the possible fill & finish methods?

We propose three types of fill   finish:
  • Clean non-sterile filling,
  • Filling followed by sterilization (autoclave or irradiation),
  • Aseptic filling.
Depending on the volume, the distribution methods can be manual or semi-automatic (X, Y, Z distributor for example). We also work with Crystal® bottles using the technique developed by Aseptic Technologies. Whatever methods used, the product is only in contact with single-use consumable to avoid cross contamination.

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.


January 2017

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!

November 2015

Bio Elpida has established a new partnership to work on the proof of concept of an innovative therapeutic approach for the treatment of a rare disease. Within this framework, contacts were established with the RENAPE network. The goal is to reach phase I/II trials by 2018.

February 2015

Bio Elpida manufactures the first therapeutic vaccine against glioblastoma to be used in a Phase II clinical trial in the US. For the past 6 years, Bio Elpida worked on the new vaccine strategy against resistant glioblastoma developed by ERC Belgium.

January 2015

Immodulon Therapeutics Ltd. announces promissing results for its phase II trial of IMM-101, a heat-killed whole cell preparation of Mycobacterium obuense used as an adjunctive immunotherapy for pancreatic cancer. IMM-101 is produced by Bio Elpida.

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

December 2014

On Thursday 4th December, Bio Elpida inaugurated its new premises at the heart of Saint Priest's technology park. This ceremony, held in the presence of many official representatives, afforded the opportunity to restate the potential great medical advances that companies such as Bio Elpida can develop.

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

September 2014

The new Saint-Priest facilities receive the Pharmaceutical and GMP accreditations for the manufacturing of Advance Therapeutic Medicinal Product (ATMP) and Active Pharmaceutical Ingredient (API) from ANSM (French Medical Regulatory Agency).

December 2013

Bio Elpida acquire new facilities in Saint-Priest. This acquisition is part of the industrial tool improvement and capacity increase strategy lead by our partners' needs.

March 2013

Bio Elpida is part of the development of the GeniusVac, a new therapeutic cancer vaccine candidate developed by EFS (French Blood Institute). This new vaccinale strategy is based on a plasmacytoïde dendritic cell line (Gen-T) charged with irradiated tumoral peptides.

November 2012

The StructGel project, among whom Bio Elpida is a partner, has been granted by the EuroNanoMed 2.

May 2012

Bio Elpida and Actino sign a partnership agreement for the development of Actino, the first immunomodulator drug candidate targetting asthma.

Bio Elpida

Founded in 2009, Bio Elpida is a Biotechnology Contract Manufacturing Company specialised in the development and manufacturing of innovative cell therapies.

The expertise of the company covers 3 areas:
In these areas, Bio Elpida offers services that include:
Bio Elpida is the first French laboratory certified by the French Health Authorities (MSNA) as a Pharmaceutical Company and authorised to manufacture Active Pharmaceutical Ingredients for experimental biological pharmaceuticals.

Bio Elpida - 97 allée Alexandre Borodine - Bâtiment 5 Cèdre 1 - 69800 Saint Priest - FRANCE - Phone: +33 (0)4 78 47 02 70 - Mail: infos@bio-elpida.com
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