Company insight
Delivering efficient speed- to-market results
Avéma Pharma Solutions: A US-based contract development and manufacturing organisation (CDMO) that offers full-service development, manufacturing and packaging of oral liquid and solid dose Rx and OTC drugs. With more than three decades of experience and nine locations throughout the US, Avéma’s team brings the integrated knowledge and dedication to quality that customers count on to help bring their products to market quickly, efficiently and at the highest quality.
D
isruptions to the supply chain, increased shipping times and limited availability of materials during the Covid-19 pandemic are encouraging overseas pharmaceutical companies that want to market in the US to turn to US-based contract development and marketing organisations (CDMOs). While at one time manufacturing overseas might have been less expensive, the extra time, uncertainty and cost involved in bringing product to the US market has changed the equation. Time to market in the competitive drug industry is critical, and pharmaceutical companies have found that even though the cost of manufacturing overseas may be lower, using a turnkey CDMO in the US provides the most truly cost-effective and timely solution to launch their products. Both cost and speed to market are dictated by more than just manufacturing. To bring a product from concept through to commercialisation efficiently, a CDMO needs to have fully integrated capabilities under its control. This includes everything from formulation development to analytical capabilities, pilot scale manufacturing, commercial scale manufacturing, serialisation and packaging.
Seamless process
One of the most common causes of delay in the development of a new product occurs during the transfer from R&D and pilot manufacturing to commercial manufacturing. Working with a CDMO like Avéma can streamline the process. As a full-service CDMO, Avéma’s processes are integrated and cohesive between its R&D development team and the manufacturing site. It’s important to start each project with DOE techniques that identify the
design techniques supports the FDA’s mandate on quality by design, which can help streamline CBE 30, NDA and ANDA filings with the FDA.
Unparalleled support When evaluating CDMOs, it’s important to find one with a history of success, the expertise to bring your product to market, a diverse mix of manufacturing equipment, and the commitment to invest in new equipment and capabilities. When it comes to developing and manufacturing liquid and solid dose drugs for Rx and OTC, Avéma Pharma Solutions offers unparalleled support. With more than three decades of experience, the company’s Miami facility has more than 90,000ft2
Avéma has extensive commercial launch capacity in tablets and capsules and is investing in new manufacturing equipment for solid dose products.
critical quality attributes of a product, develop a robust formulation and then establish a process design centred around those attributes. To ensure the seamless transition from pilot-scale manufacturing, Avéma uses proportionally sized equipment in the development process that has identical specifications to what will be used in full- scale commercial launch. This allows seamless scalability at time of commercial launch, rather than bench top or pilot manufacturing equipment. These steps are all under the supervision of a single project manager to ensure that no information is lost during scale up. As a result, Avéma can sometimes cut as many as four to eight weeks from traditional time-to-market timelines. Avéma’s incorporation of quality by
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
of FDA-registered and cGMP- compliant pharmaceutical manufacturing and research space. Avéma’s facility network covers more than one million square feet spanning nine locations across the US.
The company has extensive commercial launch capacity in tablets and capsules, and has recently brought additional liquid dose manufacturing capabilities on line at several US locations. Avéma announced earlier this year that it will invest in new manufacturing equipment to produce solid dose products and is hiring headcount in R&D and manufacturing. The company also added full on-site serialisation capabilities to its packaging lines. As a division of PL Developments, one of the leading private label manufacturers of OTC products, Avéma Pharma Solutions has the resources and expertise to bring products to market quickly, efficiently and cost effectively. ●
www.avemapharma.com 27
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65
