Contract manufacturing, By Anubhav Singh, M.pharm

CONTRACT MANUFACTURING

Presented By- Anubhav, Shani M.pharm 1st year IPR, GLA university

INTRODUCTION

• A Contract Manufacturing Organization (CMO), sometimes called a Contract Development and Manufacturing Organization (CDMO), is an organization that serves the pharmaceutical industry and provides clients with comprehensive services from drug development through manufacture.

• Services offered by CMOs include, but are not limited to: pre-formulation, formulation development, stability studies, method development, pre-clinical and Phase I clinical trial materials, late-stage clinical trial materials, formal stability, scale-up, registration batches and commercial production.

• contract manufacturers offer numerous other advantages over in-house manufacturing, including lower costs, flexibility, access to external expertise and reduced capital.

NEED OF CONTRACT MANUFACTURING

• There are many benefits as well as risks to contract manufacturing.

• With escalating R&D costs and the long path to new medicine, these companies are forced to view outsourcing or contract services as an important part of their manufacturing strategy.

• 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 contract development and manufacturing organizations (CMOs)

• 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.

EFFECT OF CONTRACT MANUFACTURING

• Success in contract manufacturing is lead by factors such as product quality, cost competitiveness, delivery schedule and CM/Customer relationship.

• The increasing complexity of pharmaceutical products has phased out manual operating methods and forced manufacturers to utilize hi-tech automatic manufacturing techniques. This works out to be more cost-effective for them since their internal resources can be focused on more important aspects of business such as product development and marketing.

• This trend has led to a boom in a phenomenon called contract manufacturing (CM).

• In other words, the manufacturing process yield depends on the knowledge of the production process expertise, and how well they are able to motivate and educate production operators.

• That’s why some time Contract manufacturing is also known as Win-Win Strategy.

Winning Factors in Contract Manufacturing • Contract manufacturing has undergone a tremendous change with the transition

from through-hole to surface-mount technology.

• Consumer awareness and global competition has made it mandatory for manufacturers to produce high-quality products at minimum cost within the delivery schedule.

• Factors important for achieving success in CM are product quality, cost competitiveness, delivery schedule and CM/Customer relationship.

Product Quality

• Now these days this is not a very difficult task for pharmaceutical companies Modern hi-tech automatic manufacturing processes are available of manufacturing consistently high-quality products, which maintains good product quality easily.

Delivery Schedule

• As All Contract manufacturer demand that their products be delivered within contractual time frames.

• The success of a CM largely depends on whether it is capable of meeting this requirement of Customers.

• Maintaining a Consistent and strict delivery schedule involves close planning of the entire production. Such a planning involves; Control of incoming materials. Maintaining an operating schedule of the production line.

• This can be taken care of by determining the number of lines and shifts needed, the manpower required and the process yield.

CM/Customers Relationship

• We know that the success of contract manufacturing depends on the mutual understanding between the contract manufacturer and the customers. The former must know how to service the latter, and must make clear his requirements (to the customer) in advance.

• The relationship depends on mutual trust, and hence the communication between the two parties must remain open. This will help both the sides to understand the requirements of maintaining the partnership.

Conclusion

• The Contract Manufacturing business is growing at a very good pace, and Pharmaceutical companies are making profitable use of this opportunity.

• success as Contract Manufacturer in the field of pharmaceutical formulation depends mainly on our product quality, low production cost, on-time delivery and the CM/Customer, Client relationship.

• Positively, Process optimization and training of production personnel is also playing a crucial role to achieve goals of our organization.

EXAMPLE- BIOCON PVT. LTD.

• Biocon leverages its India cost-base together with its extensive expertise and technology platforms to offer competitive, high quality, custom manufacturing services to a global clientele.

• Biocon’s full set of customer manufacturing capabilities, include mammalian cell culture fermentation, microbial cell culture fermentation, synthetic chemistry.

• The facility has been inspected by various international regulators including the USFDA, EU Inspectors, and Anvisa (Regulatory authority of Brazil).

ADVANTAGES OF CONTRACT MANUFACTURING

• Outsourcing to a CMO allows the pharmaceutical client to expand its technical resources without increased overhead. The client can then manage its internal resources and costs by focusing on core competencies and high-value projects while reducing or not adding infrastructure or technical staff.

• Working with a CMO also limits a client’s upfront capital investment for drug development, thus minimizing a project’s cost.

• By concentrating resources with a single-source provider, the outsourcing client can minimize technical transfer of projects or products, thereby reducing unforeseen costs and potentially speeding new products to market.

DISADVANTAGES OF CONTRACT MANUFACTURING

The pharmaceutical client using the services of a CMO does not have direct control of the project in regard to scheduling, cost, quality or accountability.

Note- For small companies, contract manufacturing may not be a good business strategy. For large companies that are trying to extend into new markets, contract manufacturing may be a good choice.

Industries that use the practice

• Many industries use this process, especially the – aerospace, defense, computer, semiconductor, energy, medical, food manufacturing, personal care, and automotive fields.

• Some types of contract manufacturing include CNC machining, complex assembly, aluminum die casting, grinding, broaching, gears, and forging.

• The pharmaceutical industry use this process with CMs called Contract manufacturing organizations.

REFERENCE

• http://www.healthbiotech.in/contract-manufacturing.html

• Images from Google Images.