What is Contract Research and Manufacturing Services?
CRAMS (Contract Research And Manufacturing Services) is one of the fastest growing segments in the pharmaceutical and biotechnology industry. It pertains to outsourcing research services/ manufacturing products to low-cost providers with world class standards, in line with international regulatory norms like the USFDA, Australian-TGA, UKMCA, and EMEA. Pharmaceutical multinationals have traditionally been outsourcing manufacture of intermediates, API’s and formulations. Since late 1990s, CRAMS has gained more importance, as MNCs have been coming under intense pressure to cut costs to maintain their profitability.
The global market for pharmaceutical outsourcing was worth US$58 billion in 2009. It is expected to grow at a CAGR of over 14% (2007–2012) to reach US$85 billion by 2012. Out of the total market, contract research was US$21 billion in 2009 and is expected to touch US$32 billion, in 2012, with an annual growth of 15%. The contract manufacturing segment of global pharmaceutical outsourcing market was at US$37 billion in 2009 accounting for the major share (approximately 63.8%) of the total market.
India, with more than 175 US FDA-approved manufacturing facilities, is one of the most preferred locations for outsourcing manufacturing services in India by the multinationals and global pharmaceutical companies.
Murli Krishna Pharma Pvt. Ltd. (MKPPL), since its inception, embarked upon the development of Prefinished Formulation intermediates employing an aqueous platform. This quest lead to the development of micro/Nano emulsion matrices which enable drugs that are poorly soluble in water through an aqueous vehicle. The quest, for developing matrices using aqueous platform and through Nano particle approach, enabled MKPPL to do significant development in the field of Oncology, corticosteroids and Ophthalmology. Development efforts in this field are specifically aimed at reducing the side effects with enhanced targeting, easier excretion and by reducing the dosage without compromising on the therapeutic index.
MKPPL has diversified its wing in terms of rendering services as a Contract Research and Manufacturing Services (CRAMS). We deliver services to our esteemed customers in 3 different aspects:
- Contract Research and Development of Formulation In-house:
This includes a technology development which could be in form of a non-infringing pathway or a novel formulation matrix with complete validations. It also involves confidential technology transfer of the process, exclusivity depending on initial terms and conditions with the customer. - Contract Manufacturing of Products as per Tech Transfer by the customer:
This includes in-house manufacturing of the product adhering to the transferred technology by the customer, under highly restrictive confidentiality agreement. - Contract Research and Manufacturing In-House:
Complying with the requirements of the customer, we design the formulation, analytical data and stability data and further upscale it to the manufacturing scale.
Modus Operandi:
Our charges for R&D are decided upon discussion with the customer. It can be an upfront development fee or a combination of development fee and as a royalty on sales of the final product. Our contract manufacturing fees are decided upon the bulk, system occupancy of the plant in terms of equipment, manpower and timeframe. We treat these projects as turn key projects, where the customer audits us time to time.
We are currently working on these 3 models with several European and US based customers. Some of these models involve development and filing of 505 B1, 505 B2 regulatory pathways for oncological drugs, anti-asthma drugs, anti-emetics, ophthalmic drugs etc. Our strength lies in a highly capable development, quality control and quality assurance system. Our complete lab and manufacturing area is approved by DSIR, Govt. of India. We also work in strong collaboration with NCL Venture Centre and Nano science and Nano technology Department, University of Mumbai.
Evolution of CRAMS
The pharmaceutical market uses outsourcing services from providers in the form of contract research and manufacturing organizations. In recent years, the concept of a comprehensive single-source provider from drug development through commercial manufacture has emerged. This concept has been implemented by providers known today as is Contract Research and Manufacturing Services (CRAMS).
CRAMS are a response to the competitive international nature of the pharmaceutical market as well as the increasing demand for outsourced services. The best-positioned service providers focus on a specific technology or dosage form and promote end-to-end continuity and efficiency for their outsourcing clients. With lower-cost international manufacturers capturing an increasing percentage of the contract manufacturing market, specialization may be an effective hedge against loss of market share.
