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About Elera

Elera Laboratories Inc. (Elera) is located in Napanee, Ontario, Canada. Elera has more than 30 years of experience in biopharmaceutical manufacturing of both human and veterinary products, and offers consulting services to clients wishing to create new products or scale up their existing product formulations.

Elera works with clients to develop and refine their formulations and prepare small-scale batches of product for testing purposes. Elera creates master batch records to ensure the process will be successfully replicated for future batches. Elera can produce product batches of up to 500 L in-house, after which Elera can assist its clients to transfer their technology to larger-scale manufacturing facilities.

ABOUT

The Founder & President

Mohamed Elrafih founded Elera in 2015 after working for more than 30 years in the pharmaceutical and biotechnology industries. He has extensive experience in design, construction and retrofitting of manufacturing facilities to GMP standards. He was responsible for the design, construction and validation of a number of facilities in Canada, Ireland and Australia. As Vice-President, Manufacturing Operations for Bioniche Life Sciences Inc. from 2001 to 2014, Mr. Elrafih managed all of the company’s human and veterinary manufacturing and plant operations in Canada, Ireland, Australia and the USA.

Mr. Elrafih has expertise in formulation development, standard operating procedures, production protocols, production line set-up, equipment sourcing, clinical trial material manufacturing, production scale-up, design and construction of pharmaceutical and biocontainment facilities, GMP documentation and validation.

Mr. Elrafih holds a B.Sc. in Microbiology from the University of Western Ontario.

Consulting Services

Elera offers technical consulting services to clients wishing to:
> Receive guidance about their product concepts
> Refine their product development vision
> Develop consistent standards for quality assurance
> Develop scalability of their product formulations

Elera can assist clients to determine the best course of action to facilitate getting their products to market, including setting up manufacturing contracts with fully regulated GMP contract development and manufacturing organizations, if required.

Contract Manufacturing Services

Aseptic Filling

> Aseptic filling is carried out in Class 100 (ISO 5) cabinets using semi-automated filling equipment
> Vial Filling: Vial size: 2 mL – 1000 mL (glass or plastic)
> Custom Filling: Elera has the flexibility to support any fill configuration or size as required by clients

Quality Control Testing

Elera uses internal and external contract laboratories to conduct all necessary testing required for each batch and as directed by the client.

Other Services

> Labeling and packaging
> Steam Sterilization (autoclave)
> Sterile/depyrogenated empty glass vials
> Sterile filtration of bulk solution
> Special requests

ELERA LABORATORIES INC.

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