WILMINGTON, N.C., Feb. 17, 2016 /satPRnews.com/ -- 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 the planned investment of at least $10.7 Million to relocate its St. Louis, MO analytical testing facility to the Cortex Innovation Center. AAI/CML provides innovative analytical testing solutions for manufacturers' new drug entities, generic drugs, animal health products, medicated consumer health products, chemicals and biopharmaceuticals. Its analytical testing business is comprised of three centers of excellence in St. Louis, MO; Wilmington, NC; and Edison, NJ to serve its regional, national and global customers. Its current St. Louis, MO facility employs approximately 80 full time staff and specializes in chemical and microbiological analytical testing including raw material testing, drug product release, stability, and environmental monitoring for both sterile and non-sterile drugs. The new facility is a response to increased customer demand and the growing trend of analytical testing outsourcing within the pharmaceutical and biotechnology industries. It will house state-of-the-art equipment in addition to its existing service offerings, and will provide new testing capabilities to meet industry and changing regulatory requirements, such as glass and plastic containers testing for pharmaceutical use, elemental impurities, disinfectant qualification and efficacy studies. The structural completion and build-out are due to be finished in the fourth quarter of 2016 and transition from the existing location will occur in the first quarter of 2017. The new facility will be operational concurrently to ensure no interruption of customer commitments in testing during the transition period until the new site is fully operational. AAI/CML's additional sites in Edison, NJ and Wilmington, NC will serve as testing support if appropriate. Each existing project will be discussed in detail with customers to ensure a seamless transition. Stability chambers at the new facility will be operational prior to removing this capability from the existing site so as not to interrupt any studies. Transfer of stability samples to the new facility will occur using temperature controlled equipment and will be monitored to ensure no deviations from specified conditions. The two facilities are within close proximity, with a travel time of less than 30 minutes from each other. Clients will be notified prior to shipment of stability samples. The new facility will have a new FDA registration number and clients will be notified in advance when their studies are planned to be relocated. AAI/CML will absorb the cost of method transfer exercises, re-verifications or method suitabilities related to the site move, ensuring relevant regulatory requirements continue to be met. In early 2017, clients will be notified by AAI/CML with details of relocation activities and a new shipping address for sample submissions. "This expansion comes at a critical time in our company's growth," said Stephan Kutzer, CEO, President and Chairman of AAI/CML. "Analytical testing is an instrumental pillar of our company and we are excited to provide our customers and the market with innovative testing solutions as part of our overall service offering including our other pillars in API, Drug Product and Development Services. "
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, AAI/CML's 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. Source: PrNewsWire All


AAIPharma / Cambridge Major Laboratories to Invest $10.7M in New Facility at Cortex Innovation Center in St. Louis, MO

WILMINGTON, N.C., Feb. 11, 2016 /satPRnews.com/ -- 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. Logo - http://photos.prnewswire.com/prnh/20150806/256637LOGO
Source: PrNewsWire All


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

WILMINGTON, Noord-Carolina, 5 februari, 2016 /satPRnews.com/ -- AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. (AAI/CML), een vooraanstaand leverancier van maatwerk productie- en ontwikkelingsdiensten voor de farmaceutische en biotechnologische industrie, kondigde vandaag diens integrale dienstverlening voor vastestofchemie en de ontwikkeling van formuleringstechnologie aan. Met dit aanbod wil de onderneming de farma- en biotech-industrie ondersteunen bij het behalen van belangrijke mijlpalen en het handhaven van stabiliteit in de geneesmiddelenontwikkeling. ProForm Select™ is de verbindende schakel tussen onze kenniscentra voor vaste stof- en proceschemie en formuleringstechnologie in Weert, Germantown, Wisconsin en Wilmington, Noord-Carolina. De focus van deze groepen ligt op het ontwerpen van efficiënte, robuuste en schaalbare processen ten behoeve van de ontwikkeling van werkzame farmaceutische bestanddelen (API's = Active Pharmaceutical Ingredients); van de eerste fase tot aan de uiteindelijke vorm en dosering. Logo - http://photos.prnewswire.com/prnh/20150806/256637LOGO
Onze integrale dienstverlening van begin- tot eindpunt biedt oplossingen voor elke ontwikkelingsfase van API's en geneesmiddelen. Dit betekent dat onze klanten tijdens iedere fase in de ontwikkeling zeker zijn van de inzet van superieure kennis en een intensieve focus. Van het bepalen van de juiste zoutkeuze en de toepassing van krachtige proceschemie tot de commerciële consistentie en kwalificatie van tweede leveranciers. Dankzij de parallelle werkwijze van onze ontwikkelexperts voor werkzame farmaceutische bestanddelen en geneesmiddelen worden de kritieke kwaliteitskenmerken optimaal gespecificeerd en gedefinieerd - een doorslaggevende factor voor het succes van een product. Hierdoor wordt de doorlooptijd aanzienlijk verkort, wat de voortgang van de producten via de klinische fase naar commercieel succes ten goede komt. ProForm Select™ biedt zijn klanten:
Through Clinic-concept
Commerciële dienstverlening
Commerciële diensten en secondaire levering
"We zijn er trots op om dit integrale pakket te kunnen aankondigen, waarmee we vastestofchemie, proceschemie en ontwikkeling van formuleringstechnologie aan elkaar koppelen. Hierdoor kunnen we de klanten van AAI/CML aanzienlijke meerwaarde bieden voor wat betreft de doorlooptijd van de klinische fase naar commercieel succes. Onze kenniscentra in Weert, Germantown en Wilmington zijn er volledig op afgestemd om proactieve oplossingen te vinden voor de toenemende complexiteit rondom klinische kandidaat-geneesmiddelen op het gebied van API-processen en de ontwikkeling van formules," aldus Syed T. Husain, Chief Commercial Officer. Over AAIPharma Services Corp. en Cambridge Major Laboratories, Inc.
AAIPharma Services Corp. en Cambridge Major Laboratories, Inc. zijn gaan samenwerken om diensten van wereldklasse te bieden op het gebied van uitgebreide farmaceutische ontwikkeling en productie. De combinatie beschikt wereldwijd over zeven vestigingen. De gezamenlijke capaciteiten omvatten API-ontwikkeling en -productie, vastestofchemie, ontwikkelen van formuleringen, analytische ontwikkeling en het uitvoeren van tests, bereiden van klinische en commerciële producten in de uiteindelijke toedieningsvorm (vaste toediening en parenteraal), verpakkingen en stabiliteitsdienstverlening. Voor al uw behoeften op het gebied van ontwikkeling en productie van geneesmiddelen en informatie, neemt u contact met ons op via: www.aaipharma.com  of  www.c-mlabs.com. Source: PrNewsWire All


AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. komt met ProForm Select™ integrale dienstverlening voor vastestofchemie en de ontwikkeling van formuleringstechnologie

AAIPharma / Cambridge Major Laboratories to Invest $15M in Additional Laboratory Capacity and Global Headquarters in Wilmington, NC
11/26/15
AAIPharma Services Corp./Cambridge Major Laboratories, Inc. (AAIPharma/CML) announces the planned investment of at least $15.8 Million to expand its laboratories and global headquarters in Wilmington, NC. The expansion will provide additional office space and development services capacity to meet the growing demands of the pharmaceutical and biotechnology markets. The Wilmington site expansion will provide up to 40,000 square feet of expanded development services capacity and include a new administration building that will become the global headquarters for the company. AAIPharma/CML recently received approval for up to $500,000 in incentives from local city and county governments over the next five years. "AAIPharma/CML's success and continued growth in Wilmington highlights the fact that life science businesses are flourishing in every corner of North Carolina," Governor Pat McCrory said. "Our state plays an increasingly key role in efforts to pioneer new treatments for people around the world, and this corporate expansion keeps that momentum going. "
Scott Satterfield, Chief Executive Officer at Wilmington Business Development, said the announcement is the culmination of months of work bringing the necessary leaders to the table and embracing the opportunities that come with a major corporate expansion. "In a project like this, there are a lot of moving parts," Satterfield said. "WBD is proud to support AAIPharma/CML's long-term growth plans, along with other exciting projects we have on the horizon. "
Approximately 5,000 square feet of lab and lab support area will be added by the end of the first quarter of 2016. It is anticipated that the new 40,000 square foot administration building will be completed by the end of 2016, followed by additional laboratory space in 2017. GHK Cape Fear Development, a fully-integrated real estate development firm located in Wilmington NC, has been engaged to develop the new headquarters building on AAIPharma/CML's Wilmington campus, located on Scientific Park Drive. "We are honored to have been selected by AAIPharma/CML to develop a state of the art Headquarters facility which will accommodate the continued growth of their business," stated Mike Brown, Partner, GHK Cape Fear Development. This expansion will include the addition of at least 50 jobs over the next five years, providing critical growth opportunities to the local area. "This expansion fits with our strategy for sustainable growth at all of our sites and is the first of several expansions to come in the near future. " said Stephan Kutzer, CEO, President and Chairman of AAIPharma / Cambridge Major Laboratories. "We appreciate the opportunity to work with local city, state and county governments to bring more jobs to the Wilmington area. "
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. Stories you Need to Know
Stories you Need to Know
It's on us. Share your news here.


AAIPharma / Cambridge Major Laboratories to Invest $15M in Additional Laboratory Capacity and Global Headquarters in Wilmington, NC

WILMINGTON, North Carolina, 26 november 2015 /satPRnews.com/ -- AAIPharma Services Corp./Cambridge Major Laboratories, Inc. (AAIPharma/CML) kondigt de geplande investering aan van ten minste $15,8 miljoen in de uitbreiding van de laboratoria en het mondiale hoofdkantoor in Wilmington, NC. De uitbreiding zal resu LTE ren in extra kantoorruimte en extra capaciteit voor ontwikkelingsservices, waarmee wordt voldaan aan de groeiende behoeften van de farmaceutische en biotechnologische markten. Logo - http://photos.prnewswire.com/prnh/20150806/256637LOGO
De uitbreiding van de vestiging in Wilmington zal voorzien in 40.000 vierkante voet voor uitgebreide capaciteit voor ontwikkelingsservices en een nieuw kantoorgebouw dat zal gaan fungeren als het mondiale hoofdkantoor van het bedrijf. AAIPharma/CML heeft recentelijk goedkeuring ontvangen voor tot $500.000 in subsidies van de lokale overheden op stads- en districtsniveau gedurende de komende vijf jaar. "Het succes en de doorzettende groei van AAIPharma/CML in Wilmington benadrukt nog eens het feit dat zakelijke mogelijkheden op het gebied van de levenswetenschappen in elke hoek van North Carolina bloeien", aldus gouverneur Pat McCrory. "Onze staat speelt een steeds belangrijker sleutelrol in pionierswerk op het gebied van nieuwe behandelingen voor mensen over de hele wereld en deze bedrijfsuitbreiding zorgt ervoor dat het momentum aan onze kant blijft". Scott Satterfield, Chief Executive Officer van Wilmington Business Development, verklaarde dat de aankondiging de culminatie vormt van maanden werk om de benodigde leiders rond de tafel te krijgen en het omarmen van de mogelijkheden die gepaard gaan met een belangrijke bedrijfsuitbreiding. "In een project als dit is er sprake van veel bewegende delen", aldus Satterfield. "WBD is er trots op om ondersteuning te bieden aan de groeiplannen voor de lange termijn van AAIPharma/CML, samen met andere spannende projecten die aan de horizon verschijnen". Ongeveer 5.000 vierkante voet aan labruimte en ondersteunende ruimte daarvoor zal tegen het eind van het eerste kwartaal van 2016 zijn toegevoegd. Volgens de verwachting zal het nieuwe kantoorgebouw van 40.000 vierkante voet tegen het eind van 2016 zijn voltooid, in 2017 gevolgd door meer laboratoriumruimte. GHK Cape Fear Development, een volledig geïntegreerd ontwikkelbedrijf voor onroerend goed gevestigd in Wilmington NC, is aangetrokken voor de ontwikkeling van het nieuwe hoofdkantoor op de campus van AAIPharma/CML in Wilmington, gelegen aan de Scientific Park Drive. "We voelen ons vereerd dat we door AAIPharma/CML zijn gekozen voor de ontwikkeling van een ultramodern hoofdkantoor dat voldoet aan alle vereisten voor de verdere groei van het bedrijf", aldus Mike Brown, Partner, GHK Cape Fear Development. De uitbreiding brengt gedurende de komende vijf jaar een toename van ten minste 50 banen met zich mee, waarmee kritieke groeimogelijkheden voor het lokale gebied worden gerealiseerd. "Deze uitbreiding past in onze strategie voor duurzame groei op al onze vestigingen en is de eerste van verschillende uitbreidingen die er in de nabije toekomst aankomen", aldus Stephan Kutzer, CEO, President en Chairman van AAIPharma / Cambridge Major Laboratories. "We hebben de mogelijkheid op prijs gesteld om samen te werken met overheden op stads-, staats- en districtsniveau aan pogingen om meer banen te creëren in het gebied rond Wilmington". Over AAIPharma Services Corp. en Cambridge Major Laboratories, Inc.
AAIPharma Services Corp. en Cambridge Major Laboratories, Inc. hebben samen een bedrijf van wereldklasse gevormd dat uitgebreide farmaceutische ontwikkelings- en productieservices levert. Met wereldwijd zeven vestigingen richten we ons gezamenlijk op de ontwikkeling en productie van API's, vastestofchemie, formuleringsontwikkeling, analytische ontwikkeling en testservices, klinische en commerciële productie van doseringsvormen (vaste dosis en parenteraal), verpakking en stabiliteitsservices. Source: PrNewsWire All


AAIPharma / Cambridge Major Laboratories investeert $15M in aanvullende laboratoriumcapaciteit en mondiaal hoofdkantoor in Wilmington, NC

CritiTech conducts research and development into the production and application of fine-particle compounds. The company has expanded its operations to include applications in fine particle API production, coatings, and internal product development.

Crititech

LAWRENCE , KS and WILMINGTON , NC -- AAIPharma Services Corp. , a biopharmaceutical drug product development and contract manufacturing company , and CritiTech , Inc. , a nanotechnology company that improves the delivery of therapeutic molecules , announce a strategic alliance to expand the reach of the CritiTech , Inc. technology .

CritiTech and AAIPharma Services Announce Strategic Alliance.
to Provide A Novel Drug Delivery Option to Pharmaceutical and Biotech Companies.

Merger

AAIPharma Services is a top contract drug development, manufacturing and analytical services company providing solutions to pharmaceutical, biotech and healthcare clients.

Wells Fargo Success Story

Professional Services

Platform Overview

aaiPharma Services

Compete with aaiPharma Services?

Compete with aaiPharma Services?

Discover the right solution for your team