Mission Statement
To make the impossible possible. Bedfordshire Biotech Limited uses its scientific and pharmaceutical expertise to bring customer ideas to life. We develop their new drug products, optimize the synthesis of therapeutic candidates, and manufacture them at the highest level of quality.
We will:
- Control our future through planning, perseverance and a commitment to quality
- Anticipate, understand and respond to our customer’s needs quickly and thoroughly
- Develop a corporate culture that rewards initiative, enthusiasm and innovation
- Be a market leader in our chosen fields, using technology to drive us to the cutting edge of research
- Provide a profitable return to all stakeholders.
We work in an environment that values:
- Honesty, integrity and accountability
- Respect and a professional approach in all of our interactions
- Perseverance and initiative on the part of all contributors
- A customer oriented focus and a commitment to quality in products and service
- A spirit of innovation, a desire to achieve, a CAN DO attitude
cGMP Manufacturing Facility
Bedfordshire Biotech Limited operates cGMP manufacturing facilities at its Toronto, Canada location. The facilities underwent a significant upgrade and expansion in 2016, including the reconstruction of the sterile filling suite with new HEPA systems, and fill line RABs, new WFI system, new vial washing-depyrogenation capabilities, as well as improved material and personnel flows.
As a Pharmaceutical Contract Manufacturing Company, Dalton’s GMP Manufacturing Facility is comprised of the following technical and administrative areas:
GMP Manufacturing and Aseptic Filling Area
The GMP Manufacturing Facility is approximately 2,500 square feet (232 square meters) and includes separate rooms for the following production functions:
- Personnel Airlock
- Materials/equipment Airlock
- cGMP Suites (2)
- cGMP Aseptic Filling Room
- Autoclave Room
- Equipment/Glass Wash Area
- Vial wash and depryogenation room
- Product Storage Room
The environmental conditions within the GMP Manufacturing Facility, including temperature, humidity, air pressure and air quality are monitored at regular intervals. Access to the GMP Manufacturing Facility is restricted to authorized personnel and is controlled by an access card system.
GMP Suites (2 suites)
The suites were designed for the production of APIs. Each GMP Manufacturing suite is fitted with stainless steel tables, an 8-foot walk-in hood and a 6-foot bench top fume hood. Terminal HEPA filters are located throughout the ceiling to maintain air quality. The walls, ceiling, and floors are finished with a highly durable epoxy based coating to maintain a high level of cleanliness. The manufacturing suites have a Grade C classification.
Aseptic Filling Area
A GMP Aseptic Filling area was originally constructed during in 2019. This area is approximately 300 square feet (28 square meters) in size and is constructed with a cleanable modular wall system. The area contains a material air lock, a personnel airlock for gowning and for compliant material and personnel flow. The fill line, which is under Restricted Access Barrier Systems (RABs) has a localized Grade A environment. There are terminal HEPA filters located in the ceiling. Pressure, temperature and humidity are all monitored continuously through Dalton’s Building Automation System. A full environmental monitoring program is in place for the GMP area.
Autoclave Room
Located in the GMP area, this room provides a localized Class A environment for all clean items being removed from the autoclave. The autoclave was installed in 2001 along with several pieces of process equipment including a pure steam generator, plant steam boiler and a RO/DI purified water system. The input side of the autoclave is located in the GMP Equipment/Glass Wash Area.
Water System
Bedfordshire Biotech Limited installed and qualified a new Steris WFI system in 2019 to support the operational needs of the GMP production areas including the new vial washing and depyrogenation room. The WFI system is compliant with U.S., EU and Canadian requirements.
cGMP Encapsulation Suite
Bedfordshire Biotech Limited operates a commercial manufacturing suite for the production of oral powder filled capsules. The capabilities include a fluid bed dryer, blending and encapsulation capabilities.
QA Sampling Room
This 100 square foot (9.3 square meter) room segregates the sampling of solvents and other raw materials for cGMP. This room features a fume extractor arm and stainless steel benching for work space.
Laboratory Services
To maintain efficiency and safety in the laboratories, separate rooms were developed to accommodate the following activities:
- Hydrogenation Room (location of 2 x 2 L Parr Reactors)
- Solvent Storage and Dispensing
- Waste Solvent Storage
- Gas Cylinder Storage
- Glass Wash and Storage
- Retained Sample Storage
Synthetic Laboratories (R&D Area)
There are two synthetic production laboratories approximately 1,100 square feet (102 square meters) each. Each laboratory has bench top fume hoods and one or two walk-in fume hoods. Dalton Pharma Services is capable of producing fine chemicals in multi-kilo batches using 22 L, 30 L, 50 L,
100 L and 250 L glass reactors.
Additional Facility Amenities
- Building Automation System (BAS), which continuously monitors temperature, humidity and pressurization in all laboratory areas. In addition the system monitors the higher hazard areas of solvent storage and the hydrogenation room in case of solvent leak and/or fire.
- Security system with proximity card access to critical areas. The GMP facility also has additional security cameras for observation purposes.
- Over 6,000 square feet (557 square meters) of technical writing areas, administrative and management offices.
- Separate shipping and receiving bays located in rear of facility ensuring smooth intake of materials and output of product.
PROGRESS BARS
COUNTERS
CLIENTS SATISFACTION
HAPPY CLIENTS
QUALITY WORK
CLIENTS SATISFACTION
QUALITY WORK
DEDICATED TEAM
HAPPY CLIENTS
To make the impossible possible. Bedfordshire Biotech Limited uses its scientific and pharmaceutical expertise to bring customer ideas to life. We develop their new drug products, optimize the synthesis of therapeutic candidates, and manufacture them at the highest level of quality.
We will:
- Control our future through planning, perseverance and a commitment to quality
- Anticipate, understand and respond to our customer’s needs quickly and thoroughly
- Develop a corporate culture that rewards initiative, enthusiasm and innovation
- Be a market leader in our chosen fields, using technology to drive us to the cutting edge of research
- Provide a profitable return to all stakeholders.
We work in an environment that values:
- Honesty, integrity and accountability
- Respect and a professional approach in all of our interactions
- Perseverance and initiative on the part of all contributors
- A customer oriented focus and a commitment to quality in products and service
- A spirit of innovation, a desire to achieve, a CAN DO attitude
The evolution of life is determined by the genetic code. The course of a company is determined by its code of values.
We have been consistently serving our values, whilst fulfilling our vision and mission.
Our vision is to be established as the best Biopharma, Pharmaceutical, Biochemical and Laboratory Company in UK and US, in terms of expertise, innovation and responsible entrepreneurship, while returning value to our stakeholders:
- the medical community: to be highly ranked by healthcare professionals for our expertise and accountability, as well as for the high quality of our products and services
- our people: provide an ideal working environment and attract the best talent in our sector
- our international partners: be the partner of choice for the world’s leading biotech companies
- our community and the environment: be a role model for our contribution to society, to the United Kingdom and US economies and to sustainable development
Integrity: Our commitment to business ethics, fairness, honesty and transparency is equally important to us, as is to achieving business success. At the end of each day, we want to be proud not only for the goals we have achieved, but also for the way we have achieved them.
Innovation: We believe we can make a difference only by thinking beyond the obvious. Prior to every action we take, we always consider new paths, so as to bring true value to the healthcare community, to patients and their families.
Commitment to Excellence: We always aim high and demand the best from ourselves and our partners. Success does not make us complacent. For everything we do, we always question ourselves whether there is a better way to do it; and if there is, we follow it.
Respect for human life: We are guided by our commitment to serve human life. To provide the medical community and patients with the most advanced therapies. To provide our employees with the recognition, job security and career prospects that each one deserves. To give back to society, so as to improve the life of those who need it the most.
Innovation
the introduction of new ideas, methods, or invention
Integrity
the quality of being honest and of always having high moral principles
Accountability
being responsible for the effects of your actions, and being willing to explain or be criticized for them
- To create innovative medicines changing SOC *1
*1 SOC (Standard of Care) : Universally applied best treatment practice in today’s medical science - To take a global perspective, and respect regional values
- To foster intellectual curiosity and strategic insight
- To provide the highest quality medical information
- To provide a stable supply of top-quality pharmaceutical products
- To be an ethical, trusted, and respectful partner
- To be accountable for achieving our goals
- To demonstrate professionalism, respect for others and teamwork
Healthier life better with our commitment to high quality, making the company one of the leading companies in the domestic and international market, God willing, that arise in order to work together with customers to provide all that is needed from the patient’s excellent health care services.
We aim to achieve the company’s leadership in the production of high quality and the provision of medicines for people and according to the international standard specifications in all from the local and international levels and to achieve the highest quality at the lowest cost, which returns to the customer and community satisfaction and meets the needs of the customers full, and also aims to become a leading company in the production of medicines and the most famous in the Europe and America.
The company trains its staff to use the latest advanced technology, and therefore the company has gained customer satisfaction by providing high quality services in the field of pharmaceutical, which require efficient and effective.
Bedfordshire Biotech
TESTIMONIALS
OUR TEAM
