News and events from Bio Elpida

If confidentiality is paramount, we can sometime share some milestones

Season greetings - 2022

Wishing together that 2022 will be for you and your collaborators the opportunity to make your ambitions come true. We humbly hope to be your partner for your project. Best wishes to all ! Download the card

Bio Elpida announces a collaboration with Brenus Pharma for the development and production of the first GMP batch for their metastatic colorectal cancer vaccine candidate (STC-1010)

Brenus Pharma, a biopharmaceutical company developing cancer vaccines, and Bio Elpida, a Lyon-based service company specialising in cell-based therapies (CDMO), announced a collaboration for the development and the production of the first GMP batch of Brenus Pharma's drug candidate (STC-1010). STC-1010 is an innovative vaccine strategy that works in synergy with existing treatments. It aims at stimulating the patient's immune system and at bypassing tumour tolerance and resistance mechanisms against solid tumours. The objective of this collaboration is to start a phase 1/2 clinical trial in early 2023. Download the press release

BioVaxys & BioElpida - Advancement toward ovarian cancer vaccine trial BioVaxys Technology and Bio Elpida signed a Term Sheet to collaborate on the clinical grade manufacturing and aseptic filling of the BXV-0918A vaccine against Stage III/Stage IV ovarian cancer. Learn more…

Season greetings - 2021

Wishing together that 2021 will be for you and your collaborators the opportunity to make your ambitions come true. We humbly hope to be the gateway and the relay for your imagination. Best wishes to all! Download the card

A new management organisation to better serve its clients and the market demands

To better serve its clients and the market demand, Bio Elpida has made a new management organisation:

• Julien Gillet-Daubin has been appointed CEO of Bio Elpida.
  Julien has a track record of building and managing complex operation. He focuses on the company operations.
• Gilles Devillers has been appointed to the role of president.
  Gilles focuses on the company strategy and the external world.
• Nathalie Tan is hired as Qualified Person and Expert for the Pharmaceutical questions.
  Nathalie brings her 12 years of experience in the pharmaceutical, medical device and biotechnology industries.
  
  

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…

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 CDMO 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 Fanny DE LUCA, 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.

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.

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!

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.

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.

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

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 phase III clinical production" stressed Gilles Devillers, co-founder of Bio Elpida.

Download the press release

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).

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.

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.

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

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