Contract Manufacturing

WuXi AppTec inks new manufacturing services agreement with Lion Biotechnologies

29-Nov-2016 By Melissa Fassbender

Lion Biotechnologies has expanded its ‘favorable’ existing relationship with WuXi AppTec to manufacture its autologous cell therapy products.

Cellectar secures 'extended partnership' to support clinical trial needs

29-Nov-2016 By Melissa Fassbender

Cellectar Biosciences has announced a partnership with the Centre for Probe Development and Commercialization (CPDC) to establish manufacturing capacity ahead of the company’s NCI-supported Ph II trial of CLR 131.

Compounding issues: gov’t watchdog releases drug compounding report

28-Nov-2016 By Melissa Fassbender

The FDA is still in “the early stages” of overseeing 503B outsourcing facilities, but efforts continue as concerns surround the oversight of drug compounders, according to a recent report by the US Government Accountability Office (GAO).

Ideal Cures adds new manufacturing facility at 'tax holiday' location

28-Nov-2016 By Melissa Fassbender

Ideal Cures has added a fourth manufacturing location at Sikkim in India to meet the demand of its local customers and to expand its global customer base.

Catalent adding OTC capsule maker Accucaps to global softgel network

28-Nov-2016 By Dan Stanton

Catalent will add two Canadian manufacturing facilities to its softgel network through the acquisition of Accucaps.

US FDA finalises contract manufacturing quality agreement guidance

24-Nov-2016 By Dan Stanton

A written quality agreement between a sponsor and a contract manufacturer can facilitate compliance with cGMP, the US FDA says in its finalised guidance.

Almac expands capabilities to meet pediatric formulations demand

23-Nov-2016 By Melissa Fassbender

The acquisition of a stick sachet packaging line from Merz expands Almac Group’s MHRA/FDA-approved UK commercial packaging facility to meet the growing demand for specialist packing solutions.

Both small and large CMOs to benefit from pharma capacity and agility demands

21-Nov-2016 By Dan Stanton

Larger CMOs are likely to be better for commercial manufacturing but small players offer niche services and agility for lower volumes, say Symbiosis and Idifarma.

Almac announces £27m global expansion

11-Nov-2016 By Melissa Fassbender

The Almac Group is planning to expand its operations in Europe and North America with an investment totaling £27m across three sites.

Slovakian CDMO Saneca ups capabilities after controlled release contract win

10-Nov-2016 By Staff Reporter

Saneca Pharma will invest in its manufacturing site in Slovakia to service a five-year agreement supplying the Menarini Group with controlled release pellets.

Trump presidency unlikely to ‘materially’ impact CROs

09-Nov-2016 By Melissa Fassbender

Analysts suggest a Trump presidency won’t have a material impact on contract research organizations – though a shake-up in trade policy could complicate the larger, global pharmaceutical industry.

New serialization platform allows CMOs to use data 'in a smarter way'

08-Nov-2016 By Melissa Fassbender

Adents and Microsoft have introduced a new platform that allows contract manufacturing organizations (CMOs) to leverage data generated during the serialization process.

Biologics manufacturing services boost for Charles River Labs in Q3

04-Nov-2016 By Gareth Macdonald

Biologics manufacturing and testing activities helped Charles River Laboratories grow in Q3 and will drive further gains say analysts.

Catalent breaks ground on WI expansion to support commercial biomanufacturing

02-Nov-2016 By Dan Stanton

The $34m expansion at its Madison, Wisconsin site will support Phase III and commercial biologics production, says Catalent.

Recipharm invests €1.2m in Italian small-scale API capabilities

02-Nov-2016 By Dan Stanton

Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.

IDT Biologika to provide live virus filling and finishing services to BARDA

25-Oct-2016 By Melissa Fassbender

IDT Biologika has been awarded a five-year contract to provide live virus filling and finishing services in a deal worth up to $50m.

PPD to support biologics, inhalation products at expanded lab

21-Oct-2016 By Melissa Fassbender

PPD has added 4,300 square feet of new laboratory space for analytical testing of biopharmaceuticals and inhalation devices to the company’s Athlone, Ireland-based GMP facility.

CordenPharma completes API process bay for category 4 compounds

19-Oct-2016 By Melissa Fassbender

This week CordenPharma announced the completion of its new highly potent API process bay for category 4 compounds.

Catalent to manufacture Moderna's personalized cancer vaccine for Ph I/II studies

17-Oct-2016 By Melissa Fassbender

Catalent has entered into an agreement with Moderna Therapeutics to support the company’s proprietary production process.

CMC Biologics and IDT Biologika expand ADC manufacturing collaboration

13-Oct-2016 By Melissa Fassbender

CMC Biologics and IDT Biologika have added Cerbios-Pharma SA and Oncotec Pharma Produktion GmbH to the companies’ PROVEO Partnership – a strategic collaboration for manufacturing antibody drug conjugates (ADCs).

Alcami launches supply chain security offering

05-Oct-2016 By Melissa Fassbender

Alcami has announced its first to market Protect Your Brand™ offering, which it said will support companies looking to implement a backup supply option.

CDMO MabPlex expands cGMP manufacturing facilities in China

05-Oct-2016 By Melissa Fassbender

MabPlex International is expanding its biomanufacturing facilities in China to meet biologic demand for “the foreseeable future.”

Compounder Empower opens FDA-registered 503B outsourcing facility

03-Oct-2016 By Melissa Fassbender

Empower Pharmacy has opened a new 15,000-square-foot facility as it looks to establish long-term viability in the compounding pharmacy industry.

Alcami enhances analytical services in Edison, NJ

27-Sep-2016 By Melissa Fassbender

The latest in a series of investments, Alcami has strengthened its analytical services capabilities at its Edison, New Jersey-based site.

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Almac: investment to ensure space, staff, larger US footprint

21-Sep-2016 By Melissa Fassbender

Yesterday, Almac Group announced a $5.2m investment in its US-based operations, which its global VP of operations said will support customers “across the drug development lifecycle.”

Almac Group announces $5.2m expansion

20-Sep-2016 By Melissa Fassbender

In conjunction with its 20th year of business in North America, Almac Group has announced a $5.2m investment at its Durham, North Carolina facilities.

CDMO Custom Pharma Services expands operations

20-Sep-2016 By Melissa Fassbender

The full-service contract development and manufacturing organization (CDMO) for investigational medicinal products has purchased a new building to expand its high containment manufacturing and development operations.

Promising Korea? CMO giant Samsung Biologics opens doors to Biopharma-Reporter

16-Sep-2016 By Dan Stanton

Since 2011, Samsung Biologics has built two plants, gained Bristol-Myers Squibb and Roche as clients and launched an IPO. With a third facility under construction, Biopharma-Reporter visited to see the CMO’s ambition in action.

Lonza licenses rights to sell synthetic AAVs to gene therapy developers

14-Sep-2016 By Gareth Macdonald

Lonza has licensed rights to synthetic adeno-associated viral (AAV) vectors developed by scientists at US hearing research centre, Massachusetts Eye and Ear.

Catalent to plug bioavailability tech gap with Pharmatek Laboratories buy

13-Sep-2016 By Gareth Macdonald

Catalent has announced its intention to buy Pharmatek Laboratories to boost its drug bioavailability offering.

Avid to construct third plant with two 1,000L single-use bioreactors

13-Sep-2016 By Dan Stanton

Avid Bioservices will construct a clinical manufacturing plant later this year just months after production began at a second facility.

LI-COR expansion offers early-phase cGMP services

12-Sep-2016 By Flora Southey

LI-COR Biosciences has expanded its production facility to offer contract manufacturing for early-phase cGMP materials.

Cambrex investment continues as industry trends ‘remain favorable’

07-Sep-2016 By Melissa Fassbender

The latest in a series of investments, Cambrex has recently expanded its Sweden-based site as part of its ongoing investment in small molecule API manufacturing across its global network of facilities.

More Cambrex capacity expansion: API firm to grow Karlskoga facility

07-Sep-2016 By Gareth Macdonald

Cambrex will spend $9m (€8m) to add large-scale manufacturing capability at its API production facility in Karlskoga, Sweden.

SGS opens dedicated extractables and leachables testing facility

06-Sep-2016 By Melissa Fassbender

SGS has opened a new Wiesbaden-based facility to serve as its global Center of Excellence for Extractable Studies and Impurities Profiling as customer demand increases.

Needle-free tech company partners with WHO as part of polio eradication effort

01-Sep-2016 By Melissa Fassbender

PharmaJet has inked a multi-year deal with the World Health Organization for its needle-free technology, which uses 80% less vaccine than traditional methods.

MassBio: drug development pipeline, candidates in clinical trials on the rise

30-Aug-2016 By Melissa Fassbender

As more Massachusetts companies reach clinical trials, demand for biomanufacturing services in the state is increasing, says report.

CMO contracts will transfer to Pfizer

Pfizer to buy AstraZeneca's antibiotic business in deal worth up to $1.5bn

24-Aug-2016 By Gareth Macdonald

Pfizer will buy most of AstraZeneca’s antibiotics business in a $1.5bn (€1.32bn) deal that will see the Anglo-Swedish drug firm continue to package Merrem at its Macclesfield, UK plant for at least the next 18 months.

BASF API biz boosts Siegfried in H1, but IT integration costs hit profits

22-Aug-2016 By Gareth Macdonald

Siegfried Holding AG has attributed a surge in API sales to the drug ingredients business it bought from BASF last year, but says that integration costs hurt profits.

Ash Stevens acquired by India-based CDMO

16-Aug-2016 By Melissa Fassbender

Ash Stevens has been acquired by Piramal Pharma Solutions, an India-based CDMO, in what the CEO said is an "incredibly powerful combination."

Serialization initiative makes progress towards uniform track and trace model

16-Aug-2016 By Melissa Fassbender

The initiative brought together competing vendors working “side by side,” focusing on a common goal of creating industry-wide standards.

WuXi AppTec subsidiary passes third US FDA inspection

15-Aug-2016 By Melissa Fassbender

WuXi AppTec has announced that its Jinshan Shanghai-based small molecule active pharmaceutical ingredient (API) and advanced intermediate manufacturing facility has passed its third US FDA inspection.

Almac Group services support first commercial orphan drug products

08-Aug-2016 By Melissa Fassbender

Almac Group has announced that two of its clients have recently received approvals of their first orphan drug product.

Engineering Pharma

Antares Vision launches serialization unit with PCI Pharma Services

04-Aug-2016 By Melissa Fassbender

Antares Vision has developed a new serialization unit in conjunction with the contract manufacturing organization (CMO), PCI Pharma Services.

CRO Velesco Pharma adds compound management services

03-Aug-2016 By Melissa Fassbender

The contract research organization (CRO) Velesco Pharma has opened a new laboratory in its Plymouth, MI-based facility to support an increased demand for materials management.

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Cambrex predicts flat generic API sales for 2016

Cambrex to start work on Pharma 4 API site in 2016

28-Jul-2016 By Gareth Macdonald

Cambrex has said it will invest around $20m in its Pharma 4 API facility before the end of the year in an effort to get ahead of the capacity utilisation curve.

First patient dosed in Ph I Zika vaccine clinical trial

27-Jul-2016 By Melissa Fassbender

Inovio Pharmaceuticals and GeneOne Life Science have dosed the first patient in the multi-center, phase I clinical trial of the companies’ Zika vaccine.

Recipharm: Q2 rev up on M&As, higher demand and anti-radiation med

25-Jul-2016 By Gareth Macdonald

Acquisitions, higher demand for sterile liquid processing and a surge in Thyrosafe orders helped Recipharm offset pricing pressure in Portugal and lower UK sales in Q2.

The patent lives in Hospira v MedCo: good news for CMOs

21-Jul-2016 By Melissa Fassbender

The Medicines Company announced last week that its Angiomax patent has been upheld – an 'important court decision' which affirms that working with CMOs won’t invalidate a company's patent.

Patheon will list on NYSE today

21-Jul-2016 By Gareth Macdonald

API and drug maker Patheon will begin trading on the New York Stock Exchange under the symbol PTHN later today.

Product Innovations

Generic method approach for determination of residual solvents in active pharmaceutical ingredients by gas chromatography

Solvents are defined as organic chemicals that are used to dissolve components. They are used during the manufacture of drug substances and can also potentially...

Pulmonary Delivery of Orally Inhaled Therapeutics

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Addressing Challenges with Clinical In-Use Testing

Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Léa shares her expertise and describes...

Outsourcing-Pharma

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