By PharmaCompass
2021-10-11
Impressions: 450
View Minakem’s portfolio of APIs & pharmaceutical intermediates & browse Minakem’s CDMO services including custom API manufacturing on PharmaCompass.
Q1. What is Minakem and what services does it offer?
Minakem is a fully integrated development partner and commercial manufacturer for pharmaceutical companies. It offers various services including custom development, custom manufacturing, API manufacturing, production of key pharmaceutical intermediates and building blocks, etc.
All development and manufacturing activities are supported by highly skilled R&D technical centres, strong and state-of-the-art analytical services including solid form and QbD laboratories. Minakem’s talented team also ensures high-quality services in quality assurance, regulatory affairs, Safety, Health and Environment (SHE).
Strong synergies within Minakem offer customers the flexibility, responsiveness, and cost-effectiveness paired with the strong technical know-how to create significant added value within supply chains.
Services Offered by Minakem:
- Custom Development and Custom Manufacturing (CDMO)
Minakem is a CDMO that has the expertise, flexibility and the resources to provide a full range of pharmaceutical custom development services. Ranging from investigational new drug (IND) support from preclinical to phase III clinical trials and technology transfer for commercial manufacturing, Minakem’s custom development experts can support products at every stage of the product life cycle.
Minakem’s custom development and custom manufacturing (CDMO) capabilities include route scouting, process development, optimization and scale-up (early to late stage, small to large scale), risk management, clinical batch supply, cGMP (FDA) and non-GMP routine production, development, optimization and validation of analytical methods, synthesis and purification of analytical reference standards and impurities, safety and toxicology assessments, etc.
- High Potent Manufacturing
Minakem offers state-of-the-art high containment Highly Potent API (HPAPI) manufacturing facilities and extremely well-trained people to handle early-stage development to scale-up and commercial manufacturing of high potent or highly potent APIs (HPAPIs) with occupational exposure limits (OEL) below to 0.1?g/m³/shift (OEB class 6).
Its main highly potent API (HPAPI) capabilities include synthetic research and development (R&D), analytical research and development (R&D), and continuous improvement.
- Analytical Services
Minakem provides a full spectrum of physical, chemical and microbiological testing services or analytical services to release products safely and on time. It has fully equipped cGMP laboratories located at its R&D centre of excellence as well as at each of the manufacturing facilities providing speed, efficiency and expertise for all projects.
- Solid State Support
To achieve controlled production of the desired crystalline candidates, Minakem has set up a team of experienced solid-state scientists working closely together to develop reliable and robust industrial crystallization processes. Its services include isomer separation, filtration and drying study, particle size reduction and control, etc.
- Quality by Design (QbD)
Minakem believes that implementation of QbD principles provides a cost-efficient approach to delivering high-quality robust processes for customers. QbD has become a crucial element within Minakem for stream-lined API process development.
- Regulatory Services
Minakem provides regulatory support for the filing of its customers in order to fulfil regulatory requirements. Minakem maintains all the documentation needed by customers to submit a New Drug Application file (NDA) or DMF registration for generic APIs.
Q2. Where are some of Minakem’s manufacturing sites located and what is their regulatory inspection history?
Minakem’s Major Development and Manufacturing Sites:
- Dunkirk, France – former AstraZeneca “prazoles” and budesonide production site
Minakem Dunkirk, France is a cGMP contract manufacturer of key pharmaceutical intermediates and APIs. The Dunkirk, France site specializes in the design of synthetic routes, route scouting and process development for new products from laboratory to commercial manufacturing with equipment and chemical technologies that are particularly suitable for multi-step synthesis.
Minakem Dunkirk, France’s core capabilities include cGMP custom synthesis and multi-ton scale generics, large scale APIs and repeat productions, organic synthesis, commercial APIs, stereoselective synthesis, budesonide and prazole synthesis, etc. Its compliance approvals include FDA (USA) - 2018, ANSM (France) - 2017, and PMDA (Japan) - 2016.
- Beuvry-la-Forêt, France - Development of APIs & cGMP manufacturing
Minakem Beuvry-la-Forêt is a global fine chemical contract manufacturer for the pharmaceutical industry. Minakem Beuvry-la-Forêt is a cGMP contract manufacturer of APIs, advanced pharmaceutical intermediates, regulatory starting materials and building blocks.
Minakem Beuvry-la-Forêt also specializes in the design of synthetic routes (route scouting) and development processes (process development) for new products from laboratory to commercial scale with equipment and chemical technologies that are particularly suitable for multi-step synthesis.
Its core competencies include cGMP custom synthesis from kilo-lab to multi-ton scale, complex multi-step API process development, manufacturing and analytical development, industrialization from feasibility to commercial scale, process continuous improvement, hydrogenation, chlorination, etc. Its compliance approvals include FDA (USA) - 2016, ANSM (France) - 2018, and PMDA (Japan) - 2016.
- Louvain-la-Neuve, Belgium – Former Ajinomoto-omnichem Site, Specialized in Vinca Alkaloids Synthesis
Founded in 1972, Minakem Louvain-la-Neuve, formerly Minakem High Potent, has built a 40+ years track record of success in supplying pharmaceutical companies with clinical and commercial scale cGMP APIs manufactured using world-class cost-effective production processes.
Through expertise and capabilities in HPAPI, controlled substances and anaesthetic products, Minakem Louvain-la-Neuve assesses and customizes their manufacturing approach to achieve the most effective manufacturing process for their customers.
Their core capabilities include High-Potent Active Pharmaceutical Ingredients (HPAPI), cytotoxic/cytostatic compounds, controlled substances, cGMP facilities (FDA, EMEA, PMDA, AFMPS), multi-step API process development, manufacturing and analytical development, development and synthesis capacities in Quality by Design (QbD) environment, etc. Its compliance approvals include FDA (USA) - 2015, AFMPS (Belgium) - 2017, PMDA (Japan) - 2016, and DMF filing experience: USA, Europe, Japan.
Q3. What are the environmental sustainability initiatives taken by Minakem?
Minakem drives sustainable solutions and takes on economic, ecological and social responsibilities. Compliance with all legislation to protect humans and the environment is one of Minakem’s basic principles. This applies to their products as well as to their processes.
Minakem is actively participating in and following-up on the evolutions of European requirements, rules and laws and constantly striving to improve procedures and processes to minimize environmental impact and prevent health risks.
Some Environmental Sustainability Initiatives Taken by Minakem:
- Sustainability Management
Minakem has created structures to promote sustainable business activities – from strategic planning to implementation. Sustainable development has been defined as the balance between 3 pillars: economic success, ecological protection and social responsibility.
- Responsible Care Management System
Minafin’s Responsible Care Management System comprises the global rules, standards and procedures for environmental and health protection, safety and security for all the steps along its value chain. Minakem takes part in this voluntary chemical industry initiative.
- Environmental protection
Minakem’s efficient processes preserve the environment, since it conserves resources and reduces emissions.
- Water, air, soil
Minakem conducts processes to avoid emissions to water, air or into the soil. Minakem has implemented many end-of-pipe environmental technologies in the last years.
- End-of-pipe environmental protection
Minakem has achieved a lot in recent decades with end-of-pipe environmental technologies. Technical equipment (filters, condensers, scrubbers) are in place to reduce emissions and wastewater treatment plants are operated on several sites. Many of its environmental protection measures are implemented during the production processes.
- Waste management
Minakem prevents and reduces waste wherever possible. If no recovery options are available, they eliminate waste in a correct and environmentally responsible manner.
- Energy and Climate Protection
Minakem has defined targets for the reduction of greenhouse gas emissions and increase of energy efficiency. They work to reduce greenhouse gas emissions in their value chain. Energy efficiency plays a key role to combine climate protection, conservation of resources and economic advantages.
Q4. What are some of the key technologies offered by Minakem?
Minakem is a technology-driven company with expertise in complex multi-step synthesis, pressure chemistry, chiral synthesis, halogenation chemistry, steroid chemistry and “prazole” chemistry. Minakem has operations in 3 different development and manufacturing sites, which are all approved by the U.S. FDA and local health agencies.
Minakem is an affiliate of the MINAFIN Group and as such has access to all technologies, resources, and capabilities to respond to its client’s needs, especially with Minascent technologies (Leuna, Germany), and Pennakem (Memphis, TN, USA). Being part of the Minafin group provides access to a true internal scientific network. The purpose is to be able to interact very quickly, everyone bringing different views, expertise and know-how.
Minakem is capable of undertaking a broad range of multi-steps synthesis in organic chemistry. It is capable of handling/managing synthetic routes that require numerous chemical steps. Minakem relies on a long-lasting experience in multi-step synthesis with a broad chemical expertise.
Minakem’s engineers and scientists are recruited from among the best internationally renowned universities and prestigious courses. The multitude of expertise is a real asset in the team. The importance given to collaboration with universities allows them to stay abreast of the technologies and new methods.
Within the R&D team, Minakem finds a whole range of know-how: installation design, security to develop new processes. Thus everything can be done in real time during the study of the project with a real consciousness/awareness of the capabilities of the industrial equipment.
Some Key Technologies Offered by Minakem
- Reaction under extreme temperature conditions
- Hydrogenation and reactions under pressure in a dedicated workshop
- Cyanidation
- Chiral chemistry
- Chemical reduction and oxidations
- Hazardous chemistry
- Continuous Flow Chemistry
- Multi-steps synthesis
- High containment capability down to OEB class 6
- Industrial preparative HPLC
- Solid state characterisation, particle size management, micronization
The PharmaCompass Newsletter – Sign Up, Stay Ahead
Feedback, help us to improve. Click here
Image Credit : Biosynthesis, tech advancements by PharmaCompass is licensed under CC BY 2.0
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
- Privacy policy
- Terms and conditions
- Disclaimers
-
-
LOOKING FOR A SUPPLIER?
