Manufacturing and Development

The Manufacturing and Development team’s primary goal is to facilitate the availability of quality-assured, affordable sexual and reproductive health medicines (SRH) and technologies worldwide.

Concept Foundation has been collaborating with the generic SRH medicines industry since it was founded in 1989, and was responsible for the manufacture and introduction of the first once a month injectable contraceptive, Cyclofem® in the early 1990s.

Photo Credit: Paul Joseph Brown Photography

Manufacturing and Development

The Manufacturing and Development team’s primary goal is to facilitate the availability of quality-assured, affordable sexual and reproductive health medicines (SRH) and technologies worldwide.

Concept Foundation has been collaborating with the generic SRH medicines industry since it was founded in 1989, and was responsible for the manufacture and introduction of the first once a month injectable contraceptive, Cyclofem® in the early 1990s.

Photo Credit: Paul Joseph Brown Photography

Technical Support to Manufacturers

  • We provide Good Manufacturing Practise (GMP) support including:
    • Site layout and design, pharmaceutical engineering
    • Manufacturing equipment qualification
    • Manufacturing process scale up and validation
    • Conduct of mock GMP inspections
  • We identify and support selection of quality-assured and cost-effective Active Pharmaceutical Ingredients (API) and raw materials
  • We support on the selection of Clinical Research Organizations (CROs) for conduct of Bioequivalence (BE) studies
  • We design BE study protocols and review and advise on BE data
  • We review and revise product dossiers pre-submission to WHO/SRA

Product Development of SRH medicines and Technologies

  • We develop bespoke solutions for achieving and meeting quality-assurance requirements while reducing manufacturing costs for both novel and existing SRH products 
  • We develop new manufacturing processes and improve existing manufacturing processes
  • We develop, improve and innovate analytical testing methods
  • We test and profile API and critical excipients
  • We conduct laboratory feasibility trials of novel or improved formulation of existing SRH medicines and technologies

OUR ACHIEVEMENTS: improving Quality of srh medicines 

We have provided technical assistance to over 30 manufacturers of generic SRH medicines in Africa, Asia, Europe and Latin America.

Our roots are anchored in the safe manufacture and supply of effective and affordable SRH medicines in low- and middle-income settings (LMIC). CF supported the manufacture and introduction of injectable contraceptive Cyclofem® in Indonesia in 1993, the emergency contraceptive Postinor-2 in 1995 and a safe medical abortion combination product Medabon® in 2007. Today we continue to capacity strengthen and collaborate with manufacturers of generic SRH medicines worldwide by providing remote and on site technical support and by sharing our unique knowledge, skills and expertise of SRH medicines and their manufacture.

 

We have supported three quarters of the generic SRH API and FPP products that are currently WHO Prequalified

In 2007, CF published “a study on the capability of manufacturers of generic hormonal contraceptives in lower- and middle-income countres” and from 2011, CF managed the Quality of Reproductive Health Medicines (QuRHM) programme,   a multi-stakeholder intervention designed to increase the number of quality-assured generic SRH medicines available for procurement and supply in LMIC settings.

Today, CF has supported 29 generic SRH finished pharmaceutical products and 6 generic SRH active pharmaceutical ingredients that are now WHO Prequalified (PQ).

Generic SRH medicines WHO Prequalified

%

WHO Prequalified generic SRH medicines received support from CF

OUR ACHIEVEMENTS: 3 monthly injectable contraception

CF has provided extensive support to manufacturers of the generic three monthly injectable contraceptive depomedroxyprogesterone acetate (DMPA) in meeting international quality-assurance standards. Since 2012, CF has provided technical assistance to a total of 9 manufacturers of intra-muscular DMPA and its API, MPA, located in Bangladesh, China, India, Indonesia and Thailand.

We have continued to improve our skills and expertise to support manufacturers to develop and innovate DMPA formulations and manufacturing processes, as well as amassing an extensive database of information and know-how of DMPA product characteristics.

 

 

Key outputs of our work on DMPA include:

  • Two generic DMPA products WHO prequalified, a third with UNFPA-ERP category 1/2
  • One MPA API product WHO prequalified, a second in progress
  • Three successful bioequivalence studies demonstrating equivalence with Pfizer’s Depo-provera
  • Extensive physico-chemical data and profiling of generic intra-muscular and subcutaneous DMPA
  • Innovative and improved analytical testing methods for DMPA finished products
  • Innovative and cost-effective aseptic manufacturing process
  • In depth knowledge of the physical characteristics of MPA API

OUR CURRENT FOCUS

TECHNICAL SUPPORT TO MANUFACTURERS

We are currently providing technical support to several manufacturers of generic SRH medicines towards obtaining WHO PQ that are located in Bangladesh, China, India, Indonesia and Russia. The products we are focusing on are injectable contraceptives DMPA and Cyclofem, emergency contraceptives, benzathine pencillin for treatment of Syphillis and the safe medical abortion combi-pack. This work is funded by generous contributions from our partners and donors.

PRODUCT DEVELOPMENT 

We are working on a generic DMPA-SC for subcutaneous self-administration with a manufacturing partner with support from the Bill & Melinda Gates Foundation and the Children’s Investment Fund Foundation.

We are conducting laboratory feasibility studies of injectable contraceptives in alternative self-injection devices with the aim of reducing the current price of the device.

We are working with CF’s Research and Innovation team to initiate and stimulate the development of improving both currently existing interventions and new developments, including conducting laboratory feasibility trials on improved formulations or potential innovative SRH medicines.