Bohus BioTech AB is a Swedish biotechnology company with a long history of developing and manufacturing hyaluronic acid raw material and products. We are specialized in research, development and manufacturing of high-quality hyaluronic acid and medical device products based on this substance. Our products are sold via a network of distributors in numerous markets around the world.
Our mission is to manufacture safe, effective and reliable hyaluronic acid based products that will help people to improve their quality of life.
Bohus BioTech meets the requirements of the Medical Device Directive (MDD 93/42/EEC) and EN ISO 13485. Our quality system is reviewed and improved on a regular basis in order to maintain compliance with our quality objectives and to meet regulatory and customer requirements.
Third-party audits are performed regularly by our notified body, mdc medical device certification GmbH, CE 0483.
Research, innovation and development are central to Bohus BioTech’s business. We cooperate with universities, hospitals and pharmaceutical and other biotechnology companies to continuously increase our knowledge. Hyaluronic acid is a well-known polysaccharide produced naturally in the human body, and the areas of application are numerous.
Our R&D department continously works on improving existing products and processes and optimize them in terms of quality and safety. Since we are specialized in hyaluronic acid we also focus on developing new products based on hyaluronic acid for existing and new applications.
At Bohus BioTech we have a modern production facility of 3,500 m2 that was completed in 2003 and where all products are manufactured. The facility is designed in accordance with ISO 14644.
Qualified cleanroom staff work in our production department and the facility is divided into two areas: blue and green zone. The green zone, which is the cleaner of the two, is certified to ISO classes 5 and 6. The blue zone is certified to ISO class 7. Both the green and blue zones have a chemistry and pharmacy department, and each has a support area. Hyaluronic acid raw material is manufactured and packed in the chemistry department and are then passed on to the pharmacy department for dissolution into various products.
Our state-of-the-art equipment, including filling and assembly machines, means that we can handle the products efficiently and safely.
Hyaluronic acid (HA) is a large molecule that consists of repeated sugar units and may be formed from several different cells. HA is found naturally in all organs of the body, in joints, in the eyes and in the skin. A person who weighs 70 kg has approx. 15 g hyaluronic acid in his body, about a third of which is metabolised every day. In the knee and joints HA has a lubricating and shock-absorbing function, and in softer tissue it gives structure and elasticity. HA’s unique ability to bind moisture also gives it many important tasks in the various transport systems of the body.
HA is an enormously large molecule with a unique ability to bind water. The molecule forms a large volume, about 1,000 times its own volume, in which water molecules can move freely in and out of the “branches”.
The structure of HA can be compared, in simple terms, to the crown of a tree (the HA molecule) in which the birds (water molecules) can move in and out. When the molecule is at rest it builds a large, tangled nest and is almost jelly-like, but when it is exposed to forces, for example when a joint is set in motion, the nest is combed out and the layers of fluid can flow over each other.
The property that hyaluronic acid gives fluids is known as pseudoplasticity. Pseudoplasticity means that fluids become less viscous when they are exposed to shear forces. For example, synovial fluid owes its properties to hyaluronic acid and is therefore shock absorbing, yet lubricating in repeated movements. As hyaluronic acid is found naturally in the body its biocompatibility is very high and it is therefore suitable for medical uses.
HA is found in many parts of the body, where its main tasks are to lubricate, cushion and retain moisture. Bohus BioTech manufactures HA-based products in three different areas, Ophthalmology, Aesthetics and Orthopedics.
In the eye HA is mainly found in the vitreous body, where it gives support to the retina and protects the eye from collapsing.
In the skin the main task of HA is to keep the skin moist in combination with other substances such as collagen and elastin. Besides this, HA makes the skin more flexible and is involved in forming new tissues by having an important role in the flow of water between tissues.
In the joints HA is found in cartilage and in synovial fluid. Cartilage acts as a sliding surface in our joints and HA is involved as one of the principal components here. HA also has the task of transporting nutrients and waste products to and from the joint cartilage. Thanks to the unique structure of hyaluronic acid, synovial fluid can act as both lubricant and shock absorber.
Besides being found in the human body, HA is also found in high concentrations in rooster combs. In order for HA to have the unique properties that make it suitable for medical uses it is necessary to manufacture a HA with a high molecular weight. Rooster combs contain high levels of a high-molecular weight hyaluronic acid that Bohus BioTech uses as a source for manufacture. The result is a product of high viscosity and thanks to the natural high molecular weight, the product does not need to be modified chemically after manufacture.
Glycosaminoglycans (GAGs) is a general name for a number of similar molecules that are found in the plant and animal kingdom and have the function of giving tissue structure. Examples of GAG molecules are heparin and chondrotoin sulfate. HA is also a GAG and is one of the largest in the animal kingdom. HA is also a polysaccharide with a repeating disaccharide unit that consists of D-glucuronic acid and N-acetyl glucosamine with ß-(1-3) bonds that are linked to a protein. Each polysaccharide unit is cross-linked with ß-(1-4) bonds. HA has a molecular weight of between 5,000 and 20,000,000 Da. HA purified from synovial fluid has a molecular weight of approx. 3,500,000 Da.