Bio Elpida Pharmaceutical Support Services
Aseptic Fill & Finish of Cell Based Product

At Bio Elpida, we can provide small-scale semi-automatic Aseptic Fill and Finish services for vials and prefilled syringes (up to 6,000 units/day). We use XYZ filling machine with peristaltic pump for the filling step and a semi-automatic stoppering machine for the vial or syringe closer.

Bio Elpida can also handle semi-automatic filling of vials (Aseptic Technology®) with a dedicated equipment (filling and sealing) for ready to fill Crystal Closed Vials.

Of course, we are fully compliant with cGMP regulation and are able to perform such service for the production of clinical batches.

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.

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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