News

AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. Announces Expanded Capabilities and Capacity for Sterile Drug Product Manufacturing in Charleston, SC

Wilmington, NC –February 4, 2016 – AAIPharma Services Corp./Cambridge Major Laboratories, Inc. (AAI/CML), a leading provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, today announces expanded sterile fill-finish capabilities and capacity in its Charleston, SC site. Substantial growth in demand has driven several recent investments.

When AAI/CML acquired the Charleston facility in 2001 it had one filling line with small-scale lyophilization. The site has invested in significant upgrades to equipment and staff since, including a small scale lyophilizer for cycle development studies conducted by an expert formulation development (FDL) team on site. Customers requiring lyophilization receive the benefits of quick turnaround times from an experienced staff that also supports sterile filling and GMP manufacturing.

A second line for GMP batches was qualified in 2015 to support continued growth in demand for sterile manufacturing, more than doubling the filling capacity for the site. This has been used for multiple regulatory submissions and is expected to produce its first commercial product in 2016. A new, mid-scale lyophilization unit has been recently installed and will be qualified by May, doubling the site’s lyophilization capacity. To complement the additional equipment capacity, a third manufacturing shift has been added, increasing capacity and scheduling flexibility.

“These upgrades to our manufacturing facility in Charleston support the overall progress of our growth as a company to meet the needs of our customers. We are excited to offer increased sterile manufacturing capacity to the market and added capabilities for specialized areas of drug product development and manufacturing,” stated Ted Dolan, Chief Operating Officer.

The sterile manufacturing facility has an excellent track record of compliance and has been referenced in 15 regulatory filings. The additional lyophilization unit extends AAI/CML’s integrated service offerings, which include formulation development, fill/finish, packaging and testing for batch sizes up to 400L.

About AAIPharma Services Corp. and Cambridge Major Laboratories, Inc.

AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. have joined to form a world-class supplier of comprehensive pharmaceutical development and manufacturing services. With seven sites across the globe, our combined capabilities include API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (solid dose and parenteral), packaging, and stability services.

Contact:
AAIPharma Services Corp. / Cambridge Major Laboratories, Inc.
Catherine Hanley
Corporate Communications
(O) 910-254-7273
catherine.hanley@aaipharma.com

AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. Announces ProForm Select™ Integrated Offering for Solid State Chemistry and Formulation Development

Wilmington, NC –February 4, 2016 – AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. (AAI/CML), a leading provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, announced today an integrated service offering for solid state chemistry and formulation development to help the pharma/biotech industry meet important milestones and maintain stability in drug development. ProForm Select™ aligns our solid-state, process chemistry and formulation development centers of excellence in Weert, The Netherlands, Germantown, Wisconsin and Wilmington, North Carolina. These groups are focused on designing efficient, robust and scalable processes to progress Active Pharmaceutical Ingredients (APIs) from early development to final dosage form.

Our integrated end-to-end offering provides solutions for APIs and drug products at every development stage. For our customers this means superior science and full attention at every stage of development. From determining the appropriate salt selection and robust process chemistry to commercial consistency and second supplier qualification, our drug product and API development experts work in parallel to specify and define the critical quality attributes that are the key to product success. This results in significantly reduced timelines that aid in the advancement of products through the clinic to provide commercial success.

process

ProForm Select™ Offers and Program Deliverables:

 
Concept Through Clinic

  • Scalable synthesis route
  • Molecular characterization including solid state
  • In depth assessment of the target product profile
  • Support of regulatory filings
  • 35% faster timeline than industry standard

 
Commercial Level Control

  • Scalable commercial process
  • Stable and robust process chemistry and drug product development
  • Integrated evaluation of drug substance and drug product target product profile
  • 35% faster timeline than industry standard

 
Commercial and Secondary Supply

  • Optimization of commercial process to reduce cost of goods, increase efficiencies
  • Line extension support
  • De-risking molecule by applying QbD principles
  • 45% faster timeline than industry standard

 

“We are excited to announce this integrated offering, which couples solid state, process chemistry and formulation development, allowing AAI/CML to make a value-added impact in our customers’ progression towards clinical and commercial success. Our centers of excellence in Weert, Germantown and Wilmington are geared toward finding proactive solutions to address the increasing API process and Drug Product formulation development complexity of clinical candidates.” stated Syed T. Husain, Chief Commercial Officer.

About AAIPharma Services Corp. and Cambridge Major Laboratories, Inc.
AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. have joined to form a world-class supplier of comprehensive pharmaceutical development and manufacturing services. With seven sites across the globe, our combined capabilities include API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (solid dose and parenteral), packaging, and stability services. Contact us for all your drug development and manufacturing needs at www.aaipharma.com and www.c-mlabs.com.
Contact:
AAIPharma Services Corp. / Cambridge Major Laboratories, Inc.
Catherine Hanley
Corporate Communications
(O) 240-344-2140
catherine.hanley@aaipharma.com

Additional Equipment and Capacity for Drug Product Manufacturing in Wilmington, NC

Wilmington, NC –December 21, 2015 – AAIPharma Services Corp./Cambridge Major Laboratories, Inc. (AAI/CML), a leading provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, today announces additional capabilities and capacity for oral solid manufacturing in its Wilmington, NC facility. These investments have been driven by the significant growth in our drug product portfolio, particularly for orphan drugs and rare disease therapies.

Some of the recent additions to our oral solid capabilities include precision coating for our fluid bed dryer (GEA/MP-4), which allows for bottom spray coating for enteric release products. Also, it allows top spray granulatation and drying for materials from the (GEA/PMA-400) high shear mixer. The additional bottom spray coating capability was introduced along with the extruder spheronizer (GEA NICAS450/NICA140). Lastly, a Bosch KKE 1700 capsule checkweighter was added to increase the encapsulation capabilities. With the addition of this equipment and a second manufacturing shift, the solid dosage capacity has increased by approximately 35%.

“Our facility upgrades inWilmington for Drug Product complement the overall progress of our laboratory and headquarters expansions. We are excited to have this top of the line equipment and added capability for specialized areas of drug product development and manufacturing,” stated Ted Dolan, Chief Operating Officer.

These new capabilities complement our existing specialties which include Minitabs, Pediatric Sprinkles, Chewable Products, Sublingual Tablets, Orally Disintegrating Tablets, Extrusion Granules, and Extrusion Spheronization. AAI/CML also has the capability to manufacture potent drugs, controlled substances, and moisture/oxygen sensitive drugs. AAI/CML will continue to invest in unique capabilties and facility upgrades as its portfolio expands.

About AAIPharma Services Corp. and Cambridge Major Laboratories, Inc.

AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. have joined to form a world-class supplier of comprehensive pharmaceutical development and manufacturing services. With seven sites across the globe, our combined capabilities include API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (solid dose and parenteral), packaging, and stability services.

Contact:
AAIPharma Services Corp. / Cambridge Major Laboratories, Inc.
Catherine Hanley
Corporate Communications
(O) 910-254-7273
catherine.hanley@aaipharma.com

AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. Invests in DE Dietrich Agitated Filter Dryer To Improve its Manufacturing Capabilities in Weert, The Netherlands

WEERT, THE NETHERLANDS – December 18, 2015 – AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. (AAI/CML), a leading provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, today announces it has upgraded its small moleculemanufacturing capabilities at its site in Weert, Netherlands with the installation of a DE Dietrich Agitated Filter Dryer for controlled isolation of Intermediates and Active Pharmaceutical Ingredients (APIs). The filter dryer, first introduced early this year, provides a completely closed system unit for isolation and drying, which minimizes operator exposure and provides a safer manufacturing environment.

“The investment in this technology has improved containment around isolation, enhanced the safety of our operating environment, and helped increase yields. Our highly active compounds can also be processed using this filter dryer with ancillary equipment, for customers that need additional protection for Occupational Exposure Limits (OELs),” stated Ted Dolan, Chief Operating Officer. “We are pleased to continue to offer more options for customers with our expanding capabilities.” The DE Dietrich Agitated Filter Dryer also provides packaging efficiencies and the ability to re-dissolve using a second solvent within one system. The unit boasts a useful volume of 490 Liters, cake volume of 180 Liters and nominal filtration area of 0.6m2.

About AAIPharma Services Corp. and Cambridge Major Laboratories, Inc.

AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. have joined to form a world-class supplier of comprehensive pharmaceutical development and manufacturing services. With seven sites across the globe, our combined capabilities include API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (solid dose and parenteral), packaging, and stability services. The family of companies is in the portfolio of American Capital, Ltd. (NASDAQ: ACAS). Contact AAI/CML for all your drug development and manufacturing needs at www.aaipharma.com and www.c-mlabs.com.

Contact:
AAIPharma Services Corp. / Cambridge Major Laboratories, Inc.
Catherine Hanley
Corporate Communications
(O) 910-254-7273
catherine.hanley@aaipharma.com